Quality & Regulatory Jobs in Pharma & Biotech

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview Lilly is currently constructing a cutting-edge facility for the...

This position works out of our Lake Forest, IL location in the Core Lab , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Senior Professional Quality (Commodities) will conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes. What You’ll Work On Develops and executes local quality strategies aligned with divisional and business objectives. Translates strategic priorities into executable long‑range programs, projects,...

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Manager, Regulatory Medical Writing to support across key therapeutic areas (X-TA) within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located High Wycombe, UK; Leiden, Netherlands; Neuss, Germany; Paris,...

The Principal Quality Engineer – DevOps is responsible for ensuring that AbbVie's IT operations and software lifecycle processes fully comply with regulatory requirements and corporate standards. This role provides leadership in defining, implementing, and optimizing quality systems through digital enablement and AI-driven solutions, and involves direct collaboration with cross-functional teams, Business stakeholders, and the Business Technology Services (BTS) Quality organization. This techno-functional expert transforms traditional quality assurance by implementing automation frameworks and DevOps best practices that enhance efficiency, reduce cycle times, and ensure regulatory compliance while optimizing CI/CD pipelines The Principal Quality Engineer – DevOps will provide oversight of quality...

The Senior Manager, IT Quality is responsible for elevating AbbVie’s IT operations and software quality practices by ensuring full compliance with regulatory requirements and corporate standards, while providing advanced strategic leadership across process improvement, risk management, and validation strategies. This role leads the development and implementation of quality systems and processes by leveraging digital enablement, data-driven methodologies, and emerging technologies including automation, AI, and advanced analytics. Collaborating directly with cross functional teams, the Senior Manager provides audit and inspection support, Corrective Action and Preventive Action execution in the Business Technology Solutions Quality area, and adoption of vendor documentation, strengthening operations...

Are you a quality-driven professional who thrives in a fast-paced environment, tackles complex issues head-on, and pivots seamlessly when priorities shift? We’re looking for a highly motivated, experienced Quality Assurance professional to lead and manage critical quality event processes, including complaints, nonconformances, CAPAs, and deviations. The Senior Quality Assurance Specialist oversees the day to day management and operations of the facility, products and vendors. Through outstanding communication, effective problem solving, and active management of ambiguous situations, the Senior Quality Assurance Specialist ensures product safety, product quality and compliance with all relevant procedures, state and federal regulations and customer expectations. Ensures...

Are you a quality-driven professional who thrives in a fast-paced environment, tackles complex issues head-on, and pivots seamlessly when priorities shift? We’re looking for a highly motivated, experienced Quality Assurance professional to lead and manage critical quality event processes, including complaints, nonconformances, CAPAs, and deviations. The Senior Quality Assurance Specialist oversees the day to day management and operations of the facility, products and vendors. Through outstanding communication, effective problem solving, and active management of ambiguous situations, the Senior Quality Assurance Specialist ensures product safety, product quality and compliance with all relevant procedures, state and federal regulations and customer expectations. Ensures...

Are you ready to shape how we communicate life-changing science to patients and healthcare professionals—safely, compliantly, and with impact? This role leads the US advertising and promotional compliance strategy for assigned products, ensuring our external communications are scientifically rigorous, fair-balanced, and fully aligned with FDA requirements. You will partner closely with cross-functional colleagues in medical, legal, regulatory, commercial, and regulatory operations to drive high-quality promotional and scientific materials from concept to submission. Can you anticipate regulatory risk and translate complex guidance into clear, actionable direction for teams? Your work will enable timely launches, confident market presence, and consistent, ethical engagement...

Job Title Quality Technician I We currently have an opening for a Quality Technician I for the Vascular division. This role can be located at our Houston, TX location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. WHAT YOU'LL DO MAIN PURPOSE OF ROLE Performs inspection and testing of purchased materials, components and products in accordance with policy and procedures. Assists Supplier Quality...

Responsibilities may include the following and other duties may be assigned. Develops, implements, administers and certifies compliance policies, procedures, and practices. Ensures alignment with legal and ethical standards of the organization. Provides compliance advice, investigates complaints and verifies deficiencies are corrected. Develops employee communication and training programs that focus on the elements of a companywide compliance program. Enforces anti-bribery and anti-competition laws. Analyzes metrics and audits functional compliance program. Maintains current knowledge of laws for financial, advertising and marketing reporting, regulations, and industry guidance that impact the company's compliance program. SPECIALIST CAREER STREAM Typically an individual contributor with responsibility in...

Software Quality Engineer I position, supporting Released Product Engineering [RPE] for the Acute Care & Monitoring [ACM] Operating Unit, is one of development, improvement, and innovation, through technical excellence and cross functional collaboration. If you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you. You will be tasked to provide quality engineering support in design and development of medical device products across the Acute Care and Monitoring [ACM] portfolio of products. Facilitating the application of Design Controls, Risk Management and Change Control processes in the evaluation and release...

The Cardiac Surgery Business is one of the fastest growing businesses, helping ECMO patients across the globe. We are an inventive and collaborative group. We are dedicated to making sure that every patient gets the best product — when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and access to healthcare. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a...

As the Regulatory Affairs Manager, you will be responsible for establishing strategy for worldwide product approval submission activities, directly responsible for execution of submission activities focused on US/EU and for ensuring regulatory compliance for Acute Care and Monitoring products. The Regulatory Affairs manager is expected to accomplish results through hands on and delegation of responsibility to individual contributors. This role will require collaboration with business partners to develop regulatory strategies to support the business goals and translate the strategies into work plans for the Regulatory Affairs teams to implement the newly created ACM OU is committed to excellence in innovation...

The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for working collaboratively to plan and carry out regulatory activities related to the Basic Energy and Access and Instrument product portfolio. This role involves preparing and submitting regulatory documents, such as 510(k) applications and CE technical files, conducting regulatory change assessments, and supporting the implementation of the EU Medical Device Regulation (MDR). The Sr. RAS translates regulatory requirements into actionable project or product requirements and works closely with multiple departments to ensure that all regulatory deliveries are completed accurately and on schedule. The position is best suited for individuals who have...

REGULATORY AFFAIRS SPECIALIST Our Neuromodulation operating unit delivers advanced therapies for chronic pain, movement disorders, and nervous system conditions, offering SCS, DBS, and targeted drug delivery. Through proven technology, clinical evidence, and innovation, we provide personalized solutions that restore function and enhance quality of life. Check us out on LinkedIn Medtronic Brain Modulation and Pain Interventions Pelvic Health Our Pelvic Health Operating Unit advances care for patients living with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies, including sacral and tibial solutions. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor, these...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we serve an extraordinary purpose. We make a difference...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we serve an extraordinary purpose. We make...

About Orthopaedics Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their...

About Orthopaedics Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their...

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans....

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Global Regulatory Leader. This position is a hybrid role and can be located in Spring House, PA; Titusville, NJ; or Raritan, NJ. Remote work options may be considered...

Brief Description of Position The Associate Director Quality Systems & Compliance within Device Quality & Regulatory will support our company's Manufacturing Division QMS Topic 3.3 – MDCP Design Controls and lead continuous improvement initiatives that support every aspect of our business processes, systems, and data. The Associate Director will collaborate with cross-functional teams to identify opportunities for improvement, address internal/external audit observations and tackle challenges, balancing effective operations with transformative initiatives. The Associate Director will work with the manufacturing division's Topic 3.3 Owner and Business Owner and has responsibility for oversight and lifecycle management of procedures related to this specific...

The Executive Director, Chemistry, Manufacturing, Control for Biologics (Biologics-CMC) is accountable for managing a team of CMC professionals and ensuring rigor in CMC regulatory strategy as well as delivery of high quality CMC submissions for late phase new modality biologics products. The Executive Director, as a Senior member of the Global Regulatory Affairs and Clinical Safety Chemistry, Manufacturing and Control organization ( GRACS CMC), will also manage significant projects as an extension of the overall GRACS CMC Leadership Team. This lead plays a critical role in driving alignment and execution globally across Regulatory CMC (Chemistry, Manufacturing & Controls), GRACS (Global...

Associate Quality Control What you will do In this vital role you will support the QC General and Immunoassay team by performing general testing methods for BLE (Breakloose and Extrusion), Moisture Determination by Karl Fisher and Solid Phase Extractions with UV Spectrometer. In addition the role will support ELISA methodologies testing for HCP (Host Cell Protein) and ProA (Protein A) Impurities and qPCR. Responsibilities Responsible for one or more of the following activities in QC analytical testing, sample and data management and equipment maintenance. Perform routine laboratory procedures such as sample analysis, standard and solution preparation. Responsible for documenting,...

Associate in Quality Control What you will do In this vital role you will contribute to maintaining the quality of products and manufacturing processes. They perform QC testing, analyze results, document findings, and work with the production team to address any quality issues. Responsibilities Responsible for one or more of the following activities in QC analytical testing, sample and data management and equipment maintenance. Perform routine laboratory procedures such as sample analysis, standard and solution preparation. Responsible for documenting, compiling, interpreting, reviewing and entering laboratory data. Providing and communicating results, maintaining/operating specialized equipment and drafting and revising documents such...

Lead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global regulatory initiatives. Lead global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of product submissions. Develop global CMC regulatory strategies to enable life-cycle product/process development strategy while maintaining global licensure and right to operate of Gilead’s operations. Lead the execution of these global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development. Lead the integration and implementation of CMC Team Leaders...

Summary Quality Assurance Operations, Laboratory Operations Support is responsible for managing Quality Assurance aspects related to Quality laboratory operations. This includes quality oversight on laboratory-based initiatives such as technical transfers, equipment and method changes, investigations, and periodic trending and reporting. This role will liaise with internal partners (e.g. Quality control, analytical technology functions) in support of daily operations and conflict resolution, and act as a QA representative on associated projects related to Quality laboratory operations. Major Duties and Responsibilities Provides quality support through quality review and approval of investigations or change controls. Reviews and approves discrepancy reporting, investigations and CAPAs...

The Senior Quality Engineer is responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations. Responsibilities Perform QA activities related to Combination Product and Medical Device Development Ensure compliance with company policies and procedures. Perform design control and risk management activities according to AbbVie's Quality System Partner within Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met Perform 3rd party supplier management...

POSITION SUMMARY The Sr. Quality Specialist leads robustness of investigations and approvals, ensuring timely triage, thorough root-cause analysis, and effective corrective/preventive actions. This skilled and competent Quality Approver role will support monitoring progress, provide feedback to investigation owners, resolve stakeholder conflicts, and escalate issues to senior management when required. Investigation Quality System Investigation Process Execute quality reviewer/approver duties, review evidence, and approve closure of investigation records. Conduct investigation record quality reviews for documentation completeness, robust root-cause analysis, and compliance with procedures. Provide coaching and actionable feedback to issue owners on best practices, system usage, and investigation execution. Facilitate the progression...

Job Title Quality Engineer Our location in Temecula, CA, currently has an opportunity for a Quality Engineer in our Vascular Division. This is a fully onsite role. The Quality Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters...

This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. The Software Compliance Engineer participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products that ensures digital applications and firmware produced by ADC is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. This person will monitor design controls...

Regulatory Policy and Intelligence Senior Manager What you will do The Global Regulatory Policy and Intelligence team advances important policy issues, aligned with Amgen’s goals and priorities, by engaging externally with regulators, industry trade associations, and patient advocates, along with internal subject matter experts across Amgen. In this vital role you will support the development, articulation, and implementation of Amgen's positions on regulatory policies that impact Amgen's business and will report to the Amgen’s U.S. Lead for Global Regulatory Policy and Intelligence. Key Responsibilities Promotes internal awareness of key regulatory policy activities, including International Council for Harmonization (ICH) activities;...

The Senior Specialist Digital and Data Quality will be responsible for the quality aspects of GMP computerized systems and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations. This includes involvement in all quality-related activities for computerized systems which are required by our Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety or data integrity. The position will work closely with stakeholders and SME’s from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the...

The Director, Global Regulatory Affairs Process Excellence & Transformation leads complex, cross-functional operational excellence initiatives across Global Regulatory Affairs (GRA). The role is responsible for identifying, designing, and implementing process improvements that enhance efficiency, consistency, and quality across GRA processes. As a key member of the GRA Process Optimization Network (GPON), this role consults with cross-team representatives to diagnose operational challenges and deliver scalable, sustainable solutions. The Director applies deep subject-matter expertise and hands-on operational excellence experience to shape objectives and drive transformation aligned with GRA and corporate goals. This is a Boston based, hybrid position requiring 3 days/week onsite....

The Regulatory Labeling Senior Manager, Rest of World (ROW) is responsible for development and maintenance of product labelling for ROW markets across all therapeutic areas. This includes prescribing and patient information and associated business processes. Key Duties and Responsibilities Provides individual contribution in development, submission, negotiation and approval of ROW labelling. Ensures compliance with labelling governance requirements and associated business processes. Participates in label working groups and representing labelling at labelling governance meetings. Works with Labelling Operations to ensure alignment with Package Component Labelling Provides input into strategy for health authority interactions and advises stakeholders of regulatory labelling requirements regarding...

At Takeda’s Brooklyn Park, MN, Facility, we manufacture Entyvio and Adcetris — monoclonal antibody therapies that help patients live healthier, brighter lives. The Engineering Validation team plays a key role in ensuring our systems and processes meet strict regulatory standards. As part of the Engineering Department, we collaborate with multiple departments and functions to safeguard product quality and patient safety. Validation is essential to earning regulatory approval and delivering trusted therapies. Interns will gain hands-on experience in a purpose-driven environment where science and teamwork come together to make a real-world impact. As an Engineering Validation Intern, you will contribute to...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. Regulatory Publishing is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner with other Global...

Responsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups...

At Medtronic, quality is at the heart of everything we do—it’s how we fulfill our Mission to alleviate pain, restore health, and extend life. As a Quality Engineer at our Nathan Lane Manufacturing site, you will be at the forefront of driving excellence in our products and processes. You’ll leverage your experience to ensure our life-changing therapies meet the highest standards of quality, compliance, and reliability. This role requires you to be onsite Monday through Friday, providing you the opportunity to collaborate closely with cross-functional teams in a fast-paced, hands-on environment. If you’re ready to take on a meaningful role...

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. Defines appropriate measures to ensure product quality. Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. Reviews software systems design, change specifications, and plans against contractual and/or process requirements. Reviews include applicable...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. As a Senior Quality Engineer, you will be responsible for supporting manufacturing operations at the Irvine Toledo site by leading activities such as NCMRs, DHR review, CAPA execution, Inspection Optimization, and NPI support. This role ensures quality compliance and drives continuous improvement across manufacturing...

As the Director, US Advertising and Promotion, Global Regulatory Affairs within our GRA Advertising and Promo Team, you will be responsible for decisions, providing strategic direction and oversight for the day-to-day activities for assigned products. Ready to get started? Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. Job Summary In this role, the candidate will serve as the resident expert in GRA US Advertising and Promotion (A&P) group on promotion, labeling, product defense, and development strategies for assigned product(s). The...

Key Responsibilities Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management. This will involve collecting all the relevant inputs from the RBM framework (CORM) as well as R&D Quality Clinical Quality Assurance on audits and inspections. As part of the upstream protocol authoring process, partner with Drug Development, in particular the CORM function, to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors and ensure...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. About the Organization builds and maintains capabilities using cutting...

Purpose The Senior Validation Engineer/Analyst functions as the lead for maintenance, engineering, and validation activities within the assigned site/area of responsibility. Equipment, facility, utilities and cleaning are within the scope of responsibility. The incumbent is the primary liaison with the Operations, engineering services, and third party vendors for executing activities within area of responsibility. All responsibilities should be executed in a manner to ensure that product quality is maintained at the appropriate level to meet R&D and Corporate Quality Standards/Expectations. Responsibilities Manage equipment, facility, utility and cleaning validation activities. Manage departmental capital projects and miscellaneous engineering activities. Work...

The QA Validation Analyst/Engineer is responsible for planning and overall approval of validation tasks. Responsibilities may also include executing validation activities. Under the direction of the Validation Section Manager, this individual will participate in the implementation of the Validation quality program at the plant under minimal supervision. Level of responsibility and performance is commensurate with grade level.The Validation Engineer responsibilities may include the review of commissioning and validation documentation completed by others, leading, authoring or reviewing investigations and implementation of preventive and corrective action, review and authoring of plant standard operating procedures, review and approval of critical planned maintenance routines,...

The Manager, Medical Device External Quality is part of AbbVie’s External and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality. The role will be based out of Lake County, IL site. This role primarily oversees external product quality assurance (EPQA) for commercial medical devices which are manufactured by third parties. In this capacity, the Manager, Medical Device External Quality, champions best practices related to sustaining product quality, equipment qualification, and manufacturing process validations. As such, the Manager, Medical Device External Quality works closely with AbbVie’s Contract Manufacturing Organizations (CMOs), relevant third-party suppliers (e.g., custom...

Job Profile Summary The Quality Engineering Service Manager for Worldwide TechServ will be responsible for managing all Compliance and Quality aspects across multiple global service and depot centers. This role ensures adherence to regulatory requirements, internal standards, and continuous improvement initiatives within a highly complex and evolving environment. - Support Quality & Compliance Strategies for Worldwide Tech Serv operations across multiple regions. -Act as the primary Quality point of contact for Worldwide Tech Serv leadership. -Ensure compliance of service centers and depot centers globally with global regulatory standards and internal policies. Provide direct oversight for regions USA, EMEA, China,...

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Global Regulatory Affairs Scholar, located in Spring House, PA, Raritan or Titusville, NJ. Global Regulatory Affairs Scholar Program Overview The Global Regulatory Affairs (GRA) Scholar Program at Johnson & Johnson...

We are searching for the best talent for Senior Supplier Quality Engineer to join our Ethicon Endo-Surgery organization located in Cincinnati, OH. The Ethicon Endo-Surgery business offers a broad range of products, platforms and technologies, including surgical staplers, clip appliers, trocars and tissue sealing devices, that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. Ethicon Endo-Surgery, Inc. was created 30 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at About Oncology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Oncology team is focused...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview Lilly is currently constructing an advanced manufacturing facility for...

About the role As a Quality Control Analyst II, you will perform compendial assessments to ensure compliance with current regulatory requirements and pharmacopeial standards. You will author and review technical documents, including protocols, standard operating procedures (SOPs), and analytical methodologies and design and coordinate analytical method onboarding activities, including execution planning, training, and documentation. How you will contribute Lead and manage the qualification of critical materials, ensuring fitness for use in analytical testing. Oversee change control management processes, including risk assessment, documentation, and implementation. Manage Corrective and Preventive Actions (CAPAs) related to analytical processes and support timely closure of quality...

About the role As a Quality Control Analyst II for QC Compliance is to provide technical expertise and support for the Operational Support functions of the QC Laboratory through ownership and participation in Quality Record management activities. How you will contribute Author and revise GMP documents and Quality Control records (e.g. Test Methods, SOPs, change controls, etc.) Train staff in general Quality Control activities and updates Train staff in Deviation and Laboratory Investigation processes and techniques Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks Identify and implement improvement initiatives to improve yield, reliability, and/or...

About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Monitors designated systems and activities, according to tasks trained and assigned, to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing...

About This Role As the Senior Manager of Quality Systems within the Implantable Device Unit (IDU), you are pivotal to ensuring regulatory compliance and upholding quality standards across the lifecycle of Class III medical devices. You will lead the development, implementation, and execution of quality system activities, aligning with FDA Quality Management System Regulation (QMSR), ISO 13485, and EU regulations. Your role is essential in maintaining the Quality Management System (QMS) and fostering a culture of quality in device development and lifecycle management. By collaborating with cross-functional teams, you will drive continuous improvement initiatives and ensure seamless management of quality...

About This Role As the Manager, Quality Systems within the Device Quality team, you will be pivotal in ensuring regulatory compliance and supporting quality across the lifecycle of Class III medical devices. This role involves developing, implementing, and executing quality system activities aligned with FDA Quality Management System Regulation (QMSR), ISO 13485, EU Medical Device Directive (MDD), and EU Medical Device Regulation (MDR). You will maintain the Implantable Device Unit Quality Management System (QMS) and foster a culture of quality in the development and lifecycle management of compliant Class III medical devices. Reporting to the Head of Device Regulatory Affairs,...

Specialist IT SOX and SAP GRC Compliance What you will do In this vital role, you will support the integrity, accuracy, and compliance of key reports and SAP GRC controls relied upon for SOX processes, helping ensure strong financial and IT control environments across the organization. Key Responsibilities Serve as a key contributor to the SOX Key Reports program, supporting reports relied upon for SOX controls. Perform detailed technical analysis of report logic, including code, queries, scripts, and data transformations, to understand how reports are generated. Validate report completeness and accuracy by reconciling report outputs to source systems and...

Target Validation Sr Director What you will do In this vital role as Senior Director, Global Research – Target Discovery you will have the opportunity to shape and lead Amgen’s Target Validation Unit within Research Biology. This research based Senior Director role will be responsible for building, leading and developing a multidisciplinary team that implements the most cutting-edge experimental and computational science and technologies to address and solve complex biological problems related to target discovery for multiple therapeutic areas. Responsibilities Lead and develop a multidisciplinary organization of ~25 scientists within Research Biology Integrate diverse experimental disciplines and workflows to...

Designs, implements and maintains quality master data to support processing materials into partially finished or finished products and transacting them in the ERP system. Responsible for planning, implementing, improving, and managing compliance of quality master data, material movement, acceptance, and control processes. Assesses and performs these processes in alignment with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Performs analysis of reports and ERP/ production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As the Senior Director - U.S. Ethics & Compliance Advisor (HIV), you will a ct as the key point of ethics and...

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. The Associate Director RA serves as the regulatory lead on relative Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies for the advertising and promotion of prescription drugs and biologics. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system...

Quality Engineer This position works out of our Barceloneta location in the Abbott Vascular division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. This is an exempt role 2nd (Second) Shift As the Quality Engineer, you’ll Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. What You’ll Do Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Identifies manufacturing process defects (scrap, nonconforming material, customer complaints), dispositions non-conforming material, leads identification...

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to Training and career development, with onboarding programs for new employees...

Quality Engineer II This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer II , you’ll support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership with...

This position works out of our corporate Abbott Park, Illinois location, or other applicable Abbott location. The Abbott Quality and Regulatory (AQR) Global compliance audit function is a corporate program which conducts audits of Quality Systems across all of Abbotts Manufacturing sites. Product quality and/or regulatory problems can negatively affect consumer health and safety, Abbott’s worldwide image, performance of Abbott earnings and market share and customer confidence and loyalty. The role has a broad responsibility that has significant impact throughout AQR and all divisions. The position is responsible for ensuring executive management is aware of compliance business risks and regulatory...

Quality Engineer This position works out of our Barceloneta location in the Abbott Vascular division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. This is an exempt role First shift (Monday to Friday) . As the Quality Engineer, you’ll Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. What You’ll Do Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Identifies manufacturing process defects (scrap, nonconforming material, customer complaints), dispositions non-conforming...

This position will work on pre-market and post-market changes for the Pelvic Health Operating Unit. SENIOR REGULATORY AFFAIRS SPECIALIST Pelvic Health Our Pelvic Health Operating Unit advances care for patients living with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies, including sacral and tibial solutions. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor, these programmable therapies deliver personalized treatment supported by strong clinical evidence and long-term outcomes—helping improve confidence, independence, and quality of life. Check us out on LinkedIn Medtronic Pelvic Health Onsite At Medtronic, we bring bold ideas forward with...

The Supplier Quality Engineer II will support Medtronic’s Brooklyn Park site by partnering closely with suppliers and internal stakeholders to ensure quality, compliance, and continuous improvement across the supply base. This role is responsible for supplier qualification, performance monitoring, and issue resolution, while driving corrective and preventive actions aligned with regulatory and quality system requirements. The ideal candidate brings strong technical judgment, a collaborative mindset, and a passion for delivering high‑quality products that ultimately improve patient outcomes. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable...

The Cardiac Rhythm Management operating group is a division within Medtronic focused on developing and manufacturing medical devices and solutions for the management of cardiac arrhythmias and heart failure. This group’s product portfolio includes implantable pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, and remote monitoring systems. CRM’s mission is to improve patient outcomes and quality of life by providing innovative therapies for the detection, prevention, and treatment of abnormal heart rhythms. The group collaborates closely with healthcare professionals and leverages advanced technology and data-driven insights to drive improvements in cardiac care. At Medtronic, we bring bold ideas forward...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Join Medtronic as a Senior Software Quality Engineer and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to drive quality for design, development, and...

If you have experience in regulatory compliance and enjoy working with cutting-edge medical technologies, we’d love to hear from you. Join us as a Senior Regulatory Affairs Specialist. Our products include different technologies (active and non-active, hardware and software) and are sold in more than 30 countries. The Senior Regulatory Affairs Specialist will be part of the US Regulatory team, reporting to Regulatory Affairs Manager, supporting a wide range of activities with frequent interactions with corporate teams in US and globally. Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document...

As a Senior Quality Engineering Manager in the Cardiac Surgery Post Market Quality organization, you will lead quality strategy and execution for a complex, global commercial portfolio. You will be accountable for ensuring patient safety, product performance, and regulatory compliance for released products, while leading a high‑performing team responsible for post‑market surveillance and risk management. This role requires deep technical expertise in risk management, design controls, and root cause investigation, along with proven leadership capability to drive change, strengthen quality culture, and deliver results in a fast‑paced environment. At Medtronic, we bring bold ideas forward with speed and decisiveness to...

This position will ensure excellence in Marketing Company GMP & GDP Quality activities to maintain the local License to Operate (LTO), driving compliance, quality performance, and continuous improvement across the US market and aligned cluster. Key Responsibilities Governance and Leadership Serve as back-up to the Cluster Lead as the GMP/GDP contact for the region. Maintain an effective governance structure that provides transparent oversight of quality activities and risk management. Act as a core member of the Marketing Company Quality Regional Leadership Team, contributing to strategy, prioritization, and resource planning. Lead, manage, and develop team members in a multi-layered organization; set...

We anticipate the application window for this opening will close on - 25 Jun 2026 Position Lead the quality engineering team, ensuring that products and processes meet regulatory standards and Medtronic’s quality expectations. Oversee quality initiatives, support compliance, and drive continuous improvement across engineering and manufacturing operations. Manage and mentor a team of quality engineers, providing guidance, training, and performance feedback. Oversee the development, implementation, and maintenance of quality systems and processes in accordance regulatory requirements including Good Manufacturing Practices (GMP) standards, 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, EU Medical Device Regulation (MDR), and State...

The Third-Party Quality team delivers strategic leadership and comprehensive oversight for Third Party Quality compliance across the MA Bio Campus. Our focus is on ensuring excellence in quality standardsand regulatory adherence in all external partnerships. The Third-Party Management Specialist is responsible for overseeing Third Party Quality for the MA BioCampus. This role is crucial in maintaining high-quality standards and ensuring compliance in our Relationships with external partners. About Sanofi We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition,...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization & Position Overview Clinical Supply and Delivery (CSD) provide the...

Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines? At AstraZeneca , we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet...

Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines? At AstraZeneca , we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet...

Within Oncology Regulatory Affairs, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to those who need it – working across our pipeline and the business to get medicines to patients as efficiently and optimally as possible. As an industry leading Oncology Regulatory function, we’re growing fast, and we’re as passionate about and committed to the development of our people as we are our business – providing an open and encouraging space to explore, learn, grow and develop across all roles and levels. At AstraZeneca, we share and are motivated by the same...

Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About AstraZeneca At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Oncology Regulatory Science and Strategy Within Oncology Regulatory Science and Strategy (ORSS) we bring...

The Associate Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations. Responsibilities Assist with proper integration and support of quality regulations drug, biologics, device and/or combination products. Conduct initial regulatory review of documents. Assist with audits...

The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant. The Senior Quality Engineer will provide Quality support for projects related to core production, new software/computer systems, new products/technologies/Automation systems. As part of the project team, the Senior Quality Engineer will ensure all activities including Qualification/Validation Strategy, Deviation Investigation and Resolution, Risk Management activities, etc. meet applicable Quality and Regulatory requirements. Additionally, the Senior Quality Engineer supports on-going production including by working with operations/quality teams for deviation resolution, auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation...

GenerateBiomedicines is seeking a dynamic and experienced Associate Director, Quality Systems and GxP Compliance to lead our Quality Systems and Compliance operations across the organization. This role will oversee core quality management functions—including training, documentation, change control, deviations, CAPAs, audits, complaints, and supplier management—ensuring GxP compliance and inspection readiness. Reporting to the Vice President, Quality this individual will manage and develop the Quality Systems while collaborating with site stakeholders to uphold GB’s commitment to regulatory excellence and operational efficiency. This is a unique opportunity to shape and strengthen Quality systems in a fast-paced biotech environment, supporting innovative therapies from...

We are seeking a proactive and experienced Regulatory Affairs Manager to lead and coordinate global regulatory activities supporting the development of our biologic therapeutics. This role will independently manage key submission components, contribute to regulatory strategy, and help drive compliance with global regulatory standards. You will work cross-functionally to influence planning and execution of development programs, helping ensure alignment with evolving regulatory requirements. The ideal candidate brings hands-on regulatory experience, strong technical and writing skills, and the ability to operate independently in a fast-paced, dynamic environment. Here's how you will contribute Independently lead the preparation and coordination of regulatory submissions...

Supplier Quality Engineer II - Software Careers That Change Lives In this exciting role as a Supplier Quality Engineer II - Software you will have responsibility for review and approval of software elements and software of unknown provenance (SOUP) items developed outside of Medtronic; partnering with sourcing teams for the selection, evaluation, approval and ongoing performance monitoring of software suppliers; and working with software development and New Product Development teams to qualify and release software product to support CRM and CDS products and devices. CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well...

Regulatory Affairs Director Oncology R&D Gaithersburg, MD Hybrid Work- on average 3 days a week from office The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialisation, and life cycle management of the assigned cell and gene therapy (CGT) product(s). You'll s erve as the global regulatory lead ( GRL ) on early - stage projects or be responsible for specific indications or jurisdictions of larger programs . You'll have the opportunity to contribute significantly to product and clinical strategy and support cross-functional alignment for governance and health authority interactions . Th e RAD also...

Location Durham, NC 3 Days in office/week The role is responsible for supporting quality partnering across BioPharmaceuticals R&D, providing data-driven insights to inspection readiness, regulatory compliance, and empowering study teams to deliver clinical studies. The Associate Director, Clinical Quality is responsible for facilitating the delivery of Quality Management activities related to Clinical Operations within R&D working with partners across the business to embed quality/compliant practices while leading and guiding proactive inspection readiness activities. They are also accountable for identifying and sharing industry trends in quality for the new business area(s), in their scope, through benchmarking with industry peers, and collectively...

We are searching for the best talent for a Senior Quality System Engineer, Field Actions to be based in Danvers, MA. Remote work options may be considered on a case-by-case basis and if approved by the company. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Purpose This exciting opportunity will allow the individual to not only collaborate across the Abiomed business for day-to-day operations, but also will regularly communicate and...

Johnson & Johnson is currently recruiting for an Innovative Medicine Transformation IT Compliance Senior Manager (Transcend Program) and the role will be based in Titusville, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn...

Johnson & Johnson is currently recruiting for a Senior Quality Operations Manager! This position can be located in Cornelia or Athens, Georgia. Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinates. At this level, the position has a greater degree of impact on the business results and typically, responsibility for managing a group of professionals. Implement and lead the quality operations organization for the Ethicon Cornelia, Georgia site by Planning, coordinating, and directing quality assurance programs designed to ensure continuous production...

We are searching for the best talent for Senior Counsel, Regulatory Law, MedTech. The Johnson & Johnson Global Legal Organization (“GLO”) is recruiting for a Senior Counsel, Regulatory Law, MedTech to support Johnson & Johnson MedTech. This position will be based in Santa Clara, CA. This Senior Counsel position is for an attorney within the Global Regulatory Legal Team of the GLO. The responsibilities of this Senior Counsel involve providing strategic legal counsel on a wide range of regulatory and compliance issues to support the development and commercialization of innovative MedTech products, services, and solutions, including digital health and robotics....

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control Analytics - CAR-T in Raritan, NJ! This shift is going to be scheduled 400pm - 200am through Sunday - Wednesday. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today...

Johnson & Johnson Vision Care, a member of Johnson & Johnson Family of Companies, is currently seeking a Sr. Software Quality Engineer, to join our outstanding team located in Jacksonville, FL! In this role the Sr. Software Quality Engineer applies tools and practices for the effective and efficient development, transfer, and maintenance of manufacturing processes throughout the product lifecycle. The Sr. Software Quality Engineer conducts assignments encompassing complete projects or portions of major projects. By determining methods and techniques to be used, will coordinate phases of work internally and externally. Key Responsibilities Support Computer Software Validation (CSV) project planning activities...

About the role The Project Management Lead (Manager level) oversees and drives cross‑functional execution of GLEC strategic initiatives, process transformation efforts, and enterprise‑wide programs. In this management role, they provide leadership, structure, and governance to ensure disciplined project delivery, effective risk management, and the achievement of measurable business outcomes. How you will contribute Own PMO execution for assigned programs. Enable and support more complex initiatives Set up and manage program governance structures, plans, RAID logs, charters, and status routines. Build integrated workplans, stakeholder maps, resourcing strategies, and decision frameworks. Manage cross-functional dependencies with DD&T, Finance, Procurement, and Legal and E&C...

This position works out of our corporate Abbott Park, Illinois location. The Abbott Quality and Regulatory (AQR) Global compliance audit function is a corporate program which conducts audits of Quality Systems across all of Abbotts Manufacturing sites. This is an onsite position. Product quality and/or regulatory problems can negatively affect consumer health and safety, Abbott’s worldwide image, performance of Abbott earnings and market share and customer confidence and loyalty. The role has a broad responsibility that has significant impact throughout AQR and all divisions. The position is responsible for ensuring audit outputs are executed to ensure effective communication such that...

As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for product market entry. What You’ll Work On Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed. Reviews and evaluates communications to ensure communications convey all necessary...

Quality Engineer This position works out of our Arecibo Location in the Abbott CRM division. Abbott CRM provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. This is an exempt role First Shift As the Quality Engineer, you’ll Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. What You’ll Do Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Identifies manufacturing process defects (scrap, nonconforming material, customer complaints), dispositions non-conforming material, leads identification of...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. We prefer a candidate that is site-based (local to Foster City). You will be on site Tuesday, Wednesday, Thursday. For non-local talent,...

Key Responsibilities Provide leadership to the global inflammation regulatory organization to advance Gilead’s portfolio across the full product lifecycle, from Phase I through Phase IV, in alignment with corporate objectives. Leverage in-depth regulatory knowledge and inflammation expertise to deliver strategic and technical guidance, including innovative and precedent‑informed regulatory approaches to global registration. Dissect and distill complex regulatory issues to provide clear strategic direction and support interactions with health authorities, including preparation of high‑quality regulatory content. Hire, develop, and retain diverse top talent; set clear and aspirational goals; and coach direct reports on performance, development, and career progression. Foster a culture...

The Vice President, Cell Therapy Global Quality is accountable for development, deployment and execution of the Quality strategy for the Cell Therapy Development and Cell Therapy Operations organizations. The role is responsible for building, leading and optimizing the Quality organization throughout the global cell therapy network, including responsibility for Patient Operations Quality Internal Manufacturing Quality External Manufacturing and Supply Chain Quality Global Product Quality, consisting of Development Quality, Product Lifecycle and CMC Quality Analytical Science and Technology Quality Systems & Compliance The role leads the Quality organization in the development, commercialization, supply, and lifecycle management of cell therapy products to...

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans....

This is a seasoned individual contributor role responsible for developing, implementing, and maintaining rigorous quality standards and protocols during the sustaining and post-market phases of the product lifecycle. The Specialist serves as a key technical expert, working with limited supervision, who must demonstrate substantial expertise in risk management (e.g., assessing product risk and supporting field actions). This role involves providing design-quality oversight for product changes (including design change analysis and DHF maintenance), and using advanced inspection, testing, and statistical analysis methods to ensure product precision, accuracy, and compliance with all required standards and documentation. A successful candidate will drive process...

We are seeking a seasoned IT Validation/Quality Assurance professional with life sciences expertise to join our team as Associate Director, IT Validation. Reporting to the Director, IT Compliance and Processes, in this role, you will lead CSV/CSA activities and ensure that GxP computerized systems across R&D and Technical Operations are implemented, validated, and maintained in compliance with FDA, EMA, ICH, GAMP and other Health Authority requirements, good data integrity and data quality standards and industry guidelines/best practices. You will provide validation oversight as well as hands-on development of the computer system validation/computer software assurance lifecycle and associated deliverables from design...

The Senior Quality Engineer is responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations. Responsibilities Perform QA activities related to Combination Product and Medical Device Development Ensure compliance with company policies and procedures. Perform design control and risk management activities according to AbbVie's Quality System Partner within Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met Perform 3rd party supplier management...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

Nourish the world and your career as part of the Nutrition team at Abbott. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna®– to help get the nutrients they need to live their healthiest life. Our Global Supplier Quality Assurance (GSQA) group in Columbus, OH currently has an opportunity for a Project Leader, Ingredient Supplier QA. The primary function of the GSQA group is to...

Sr. Specialist Quality Assurance Participates as a member of the Non-Product Software Quality Assurance (SWQA) team for Abbott Diabetes Care. Ensures systems / applications produced in support of the Quality System or consumer products are developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software or systems /applications in support of the Quality System. Coordinate activities with other engineering disciplines, departments, and contractors. What You’ll Work On Completes software quality tasks in accordance with current Quality System...

Supplier Quality Engineer This position works out of our Pomona, CA location in the Toxicology Business Unite , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Supplier Quality Engineer is part of the product development core team responsible for quality engineering deliverables including specification development, risk management, process and test method characterization and control plan development. What You’ll Work On Plans and perform...

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to Career development with an international company where you can grow the career you dream of . Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year An excellent retirement savings...

Sr. Specialist Quality Assurance Participates as a member of the Non-Product Software Quality Assurance (SWQA) team for Abbott Diabetes Care. Ensures systems / applications produced in support of the Quality System or consumer products are developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software or systems /applications in support of the Quality System. Coordinate activities with other engineering disciplines, departments, and contractors. What You’ll Work On Completes software quality tasks in accordance with current Quality System...

We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN or Plano, TX. This position performs three 1-year rotations that include specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. Additionally, during certain rotational periods the position may be responsible for regulatory operations activities such as logistics management of global product release, and maintaining tools needed for managing global regulatory...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As an Associate Director, Quality Organization Change Management at Gilead you will play a pivotal role in overseeing global quality initiatives. **This...

About the role Computerized Systems Validation Engineer I is responsible for supporting the engineering operations within the organization. This role involves applying theoretical knowledge to practical scenarios, ensuring quality, safety, and performance standards are met in production processes. The role supports Takeda's mission by ensuring reliable and efficient engineering operations. How you will contribute Support site projects, technical transfers, and ongoing validation maintenance. Primarily responsible for the design, authorship, and execution of commissioning, qualification and/or validation studies for any of the following major disciplines Assist in testing equipment Ensure standards of quality, cost, safety, reliability, and performance are met in...

Senior Director, Global Regulatory Strategy - Early Development & Business Development Location Boston, MA At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week . Our head office is purposely designed with collaboration in mind, providing...

In AstraZeneca's Cell Therapy division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying , and even curing some of the world's most complex diseases. We have the potential to grow our pipeline and positively impact the lives of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. This role is part of the Cell Therapy Supply Chain team tasked with supporting critical...

This is a full time on-site position with M-F business hours About This Role The Sr. Associate I is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. This individual has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. The Sr. Associate I provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in a manner consistent with site and Corporate policies, cGMP, safety,...

Senior Manager QA What you will do At Amgen, our mission to serve patients drives everything we do. At our Ohio site, we are building a culture where quality is not just a function—it’s a mindset. We’re seeking a Senior Manager, Quality Assurance who is passionate about leadership, thrives in a dynamic environment, and is ready to make a tangible impact on product quality and patient safety. This is more than a role, it’s an opportunity to lead from the front, shape quality culture, and ensure we deliver safe, effective therapies to patients worldwide. Responsibilities Lead, coach and develop...

Global Quality Compliance, Senior Manager What you will do Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities Coordinates and leads or participates in Global Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, Critical Service Providers, Suppliers, Partners, and Wholesalers to assess compliance with all applicable regulations and to identify top compliance risks. Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to...

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans....

The Senior Quality Specialist is responsible for leading and supporting Corrective and Preventive Action (CAPA) activities to ensure compliance with regulatory requirements and Medtronic quality standards. This role partners cross‑functionally with Manufacturing, Quality, Engineering, and other stakeholders to investigate quality issues, identify root causes, implement effective corrective and preventive actions, and verify long‑term effectiveness. This role will support training system effectiveness by ensuring training matrices are properly assigned to all job profiles, training documents are created, updated, and maintained. The role includes developing and maintaining work instructions, assisting management with training assignments, and supporting alignment of quality requirements. At Medtronic,...

In support of the Chief Quality Officer, define and shape the Quality strategy for the Global Business Unit (GBU) Manufacturing Quality Network which includes the biologics & pharma operating units, internally and externally, to ensure a high level of cGMP compliance and the safety, efficacy, and quality of all bio and pharma manufactured commercial products. Responsible for direction of the quality operations teams supporting manufacturing, laboratory operations, and releasing or certifying of all BMS’ products produced, including internal and external manufacturing. This role will ensure consistency and alignment in the overall GBU Network Strategy and operational performance. The role will...

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly,...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for Analyst Quality Control The QC Analyst conducts biochemical, microbiological, and/or general chemical testing of raw material, in-process, or final product samples submitted to the QC laboratories. The position requires testing to...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Quality Inspector II . Purpose The Quality Inspector II will perform inspections, checks, tests, review of quality documents such as a device history report and sampling procedures of incoming materials, parts/components, partially assembled or finished medical devices. Provide support as needed to the Operations group. You will be responsible for Perform inspections on...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Quality Inspector I. Purpose The Quality Inspector I will perform inspections, checks, tests, review of quality documents such as a device history report and sampling procedures of incoming materials, parts/components, partially assembled or finished medical devices. Provide support as needed to the Operations group. You will be responsible for Perform inspections on multiple...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. This position will support international registrations for the Acute Care & Monitoring Operating Unit products. Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Leads or compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling,...

The Opportunity The Healthcare Compliance Office (HCO) Sr. Compliance Manager Auditing position leads internal compliance audits across Genentech This individual is responsible for conducting complex, in-depth healthcare compliance audits and facilitating corrective action plans within areas of the Genentech organization. This individual designs and effectively executes HCO audits by working closely with other members of the HCO Auditing team or by leading a team comprised of consultants and legal counsel. In the role, this individual Uses knowledge of compliance risks and understanding of database reporting capabilities to develop audit strategies and audit plans Executes routine and ad hoc healthcare compliance...

As sequencing technology advances into clinical, diagnostic, and AI-driven applications, the regulatory and quality requirements governing software have become as demanding as those governing physical devices. IEC 62304 compliance, SaMD classification, EU AI Act readiness, and cybersecurity within the QMS are front-line regulatory risks. The Sr Director, Software Quality will establish and lead Illumina's standalone Software Quality function, reporting directly to the VP of Global Quality. This leader will define the operating model, build the team, and own the end-to-end quality framework for all software products and software-driven medical devices across Illumina's global portfolio. The role requires deep technical expertise,...

Job Title Quality Engineer We currently have an opening for a Quality Engineer for the Vascular division. This role is located at our Temecula, CA location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. MAIN RESPONSIBILITIES Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Identifies and controls Manufacturing process defects (scrap, nonconforming material, custom complaints) by participating in efforts/teams focused...

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infections disease, cardiometabolic, informatics and toxicology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage...

Job Title Software Design Quality Engineer We currently have an opening for a Software Design Quality Engineer for the Vascular division. This role is located at our Westford, MA location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. MAIN RESPONSIBILITIES Lead, execute and support on-time completion of Quality Engineering deliverables from product concept through commercialization, including but not limited to risk management activities...

Job Title Quality Engineer We currently have an opening for a Quality Engineer for the Vascular division. This role is located at our Temecula, CA location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. MAIN RESPONSIBILITIES Provides hands-on quality engineering support for warehouse and distribution operations within a regulated medical device environment. This role ensures compliance with FDA Quality System Regulation (21 CFR...

Provide Quality Control (QC) leadership and ownership for site investigations and CAPA execution related to QC operations and laboratory activities. This role is accountable for ensuring investigations are scientifically sound, timely, and compliant, while partnering closely with Quality Assurance for independent oversight and regulatory alignment. Duties / Responsibilities Lead and manage the deviation and investigation process for Quality Control operations, including analytical testing, microbiology, bioassay, environmental monitoring, and laboratory systems. Serve as the QC subject matter expert (SME) for root cause analysis, CAPA development, and effectiveness verification related to laboratory and testing-related events. Ensure investigations are data-driven, scientifically rigorous, and...

PRINCIPAL OBJECTIVE OF THE POSITION The Associate Director, Quality Control Microbiology Laboratory Operations is accountable for the strategic leadership, governance, and GMP-compliant execution of microbiological quality control activities supporting commercial and clinical biologics manufacturing at the Devens site. The role ensures microbiology laboratory operations, systems, and personnel consistently meet regulatory requirements, internal Quality Management System (QMS) standards, and inspection readiness expectations to protect patient safety, product quality, and data integrity. Major Duties and Responsibilities Provide strategic and operational leadership for GMP Microbiology laboratory activities, including environmental and utility monitoring, sterility assurance, microbial testing, and microbiological release support. Establish and maintain...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The Quality Systems Health & Performance Management Leader is accountable for...

Clinical Regulatory Writer, Associate Director or Manager Location Boston, MA - Hybrid (3 days onsite) Introduction to role Are you ready to be part of the solution, turning drug development strategies into reality? As a Clinical Regulatory Writer, you will play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca’s core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals. Accountabilities As a Clinical Regulatory...

Do you have a passion for Science ? Would you like to apply your expertise to impact a company that follows science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. About AstraZeneca in Gaithersburg, MD Our Gaithersburg,...

Purpose AbbVie is dedicated to delivering innovative, safe, and effective medicines and products that address critical health issues and make a remarkable impact on people's lives. As a Global Trade Compliance organization, we are committed to driving and pioneering best-in-class trade compliance practices in a dynamic global environment. The Supervisor, GTC – Tariff Classification, is responsible for ensuring that AbbVie’s cross-border transactions are executed in compliance with import/export regulations worldwide. This Supervisor will play a vital role in the leveraging of technology solutions in the tariff classification area that enables import/export compliance and supports cost savings activities globally. The Supervisor,...

Responsibilities Sets up, leads and develops a team responsible for Quality Control Coordination, Quality Compliance, Exception and Change Management, Qualification and Maintenance and, analytical Outsourcing. Develops and implements short and mid-term strategy for the Compliance group and manages effectively local and global interfaces (within PDS&T, with Operations QC, R&D and Ops QA, Development Sciences, Regulatory, etc.). Develops/aligns local processes/workflows and GMP approaches within PDS&T LC Develops/aligns in close cooperation with other PDS&T sites and partner organizations global lean processes/workflows and GMP approaches cross-functionally. Manages effectively local/global interfaces (Operations QC, R&D and Ops QA, Development Sciences, Regulatory, etc..) and drives cross-functional...

The Senior Quality Engineer is responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations. Responsibilities Perform QA activities related to Combination Product and Medical Device Development Ensure compliance with company policies and procedures. Perform design control and risk management activities according to AbbVie's Quality System Partner within Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met Perform 3rd party supplier management...

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. This role will primarily support Manufacturing Operations and will serve as the Quality Integrated Process Team (IPT) Representative for the...

The Senior Supplier Quality Assurance (SQA) is responsible for developing and executing supplier quality strategy, ensuring compliance with global regulatory requirements, and improving supplier performance across a diverse supply base. This role leads supplier auditing, qualification, risk management, and issue resolution, partnering closely with Procurement, R&D, Manufacturing, Regulatory Affairs, and other departments within the quality organization. This role will also learn to balance supplier requirements between medical device and consumer businesses. The individual will serve as the primary escalation point for critical supplier issues and supports major regulatory inspections across the business. What You’ll Work On Lead supplier quality assurance...

Senior Project Leader TPM (Third Party Manufacturing) Quality Assurance Our location in Columbus OH currently has an opportunity for a Senior Project Leader TPM (Third Party Manufacturing) Quality Assurance. This individual will serve as the primary account manager for all things quality for multiple suppliers that manufacture nutritional products on behalf of Abbott Nutrition. The primary duties within this role include (1) event management and responsibilities for the Abbott CAPA system, (2) project management as it relates to new product launches, trials, rebranding, etc., and (3) compliance within the Abbott quality system as it relates to our supplier base....

Regulatory Affairs Specialist This position works out of our Lake Forest, IL location in the Core Lab , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Regulatory Affairs Specialist will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The Regulatory Affairs Specialist supports the global commercialization of In Vitro Diagnostic (IVD) devices by providing regulatory input...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as a Senior Quality Engineer you will have responsibility for the Quality and Compliance of process development and manufacturing of implantable Cardiac and Neuromodulation medical device related products at Medtronic’s Tempe Campus. Responsibilities may include the following and other duties...

Location Louisville, Colorado and Parker, Colorado (will alternate between sites throughout the week) Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This is an on-site role supporting the Global Supplier Quality organization at the Louisville, CO and Parker, CO manufacturing facilities. As a Sr. Supplier Quality Engineer, you will serve as...

At Medtronic, quality is at the heart of everything we do—it’s how we fulfill our Mission to alleviate pain, restore health, and extend life. As a Quality Engineer II at our Nathan Lane Manufacturing site, you will be at the forefront of driving excellence in our products and processes. You’ll leverage your experience to ensure our life-changing therapies meet the highest standards of quality, compliance, and reliability. This role requires you to be onsite Monday through Friday, providing you the opportunity to collaborate closely with cross-functional teams in a fast-paced, hands-on environment. If you’re ready to take on a meaningful...

The Principal Supplier Quality Engineer for New Product Development (NPD) within the Cardiac Surgery Operating Unit (OU) is responsible for driving supplier quality excellence to support the successful development and launch of innovative cardiac surgery devices. This role collaborates with cross-functional teams and suppliers to ensure robust component development, qualification, and release processes that align with program timelines and regulatory requirements. The ideal candidate will excel in managing supplier changes during NPD programs, effectively communicating and resolving issues, and assessing the impact of changes on existing qualifications and validations to ensure seamless program execution. This role will develop supplier quality...

The Associate Director of GCP Operational QA performs advanced GCP Quality Assurance oversight and management activities of clinical trial operations and applicable vendors, to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols and Vertex policies and procedures and quality standards as set forth in the Quality Management System. These activities include the development and execution of study level audit plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, monitoring and trending of quality risks, issues and compliance metrics, investigation and CAPA management and proactive inspection readiness activities....

Job Title Sr. Engineer Supplier Quality This position works out of our Temecula, CA location in the AVD Vascular division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. We are seeking a high caliber Senior Engineer Supplier Quality d rives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You’ll Work On Assess potential new suppliers for technical, quality and manufacturing...

Objective / Purpose The Director, Target Validation Sciences will lead a next-generation, automation-enabled assay hub for human disease–relevant target validation. Working closely with the Lab of Tomorrow (Takeda’s lab automation and digitalization initiative), this role will transform how target validation is conducted by integrating advanced 3D disease models, organ-on-a-chip technologies, automation, and AI-enabled data analytics into scalable, decision-driving platforms. This role will contribute to and help shape the scientific direction of target validation across therapeutic areas, modernize workflows through digitalization, and support assay transfer across functions while driving the standardization and centralization of assay platforms, accelerating portfolio progression. Accountabilities Establish...

The Associate Director, Customs Valuation Compliance & Reporting, is a critical compliance role that actively partners across the enterprise and leads the operations and strategic design of the end-to-end customs valuation and reconciliation process. Responsibilities include leading the financial planning and reporting of customs tariff impact to AbbVie’s imports (primarily focused on the Americas region) by conducting relevant variance analyses, scenario modeling and developing executive-ready reports; leading customs valuation initiatives in collaboration with stakeholders from other departments; and ensuring accuracy and predictability of tariff costs and other customs reporting metrics. Responsibilities Ensure compliance with U.S. Customs and Border Protection laws...

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly,...

Quality Technician II This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer Technician II, you will support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership...

Quality Engineer I- 2nd Shift This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the 2nd shift Quality Engineer I , you will assure new or modified products conform to requirements and establish compliance with the quality system. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs....

Quality Engineer II This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer II , you’ll support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership with...

Plant Quality Compliance Manager The Plant Quality Compliance Manager leads all plant‑level quality and compliance activities to ensure alignment with GMPs, FDA regulations, and applicable regulatory standards. This role provides leadership to plant teams, ensures effective execution of CAPAs, maintains audit readiness, and serves as the SQF Practitioner and HACCP Coordinator. The position also supports continuous improvement initiatives and elevates compliance risks and trends to plant and divisional leadership. This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies...

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned...

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans....

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities Collect Environmental Monitoring (Viable Air, Viable Surface, Non-Viable Air Samples) and Critical...

Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions Location US Remote About the role As an Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions, you will p rovide oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business units and affiliates. You will drive a fit-for-use global Quality framework that elevates the capabilities in the business units and the affiliate and enables them to deliver their clinical research and pharmacovigilance-related regulated activities with high compliance and agility. You will also establish and maintain relationships with key stakeholders outside R&D such...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as a Quality Technician III supporting the Cardiac Ablation Solutions organization, you will have responsibility for the inspection and testing of returned products as part of the complaint handling process. The Technician will be capable of supporting...

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shift NIGHT shift available, Panama schedule ( 12-hour shift patterns with a 2-2-3 work cycle including weekends and holidays) 6 pm to 6am Duties/Responsibilities Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations. Able to interpret problems and effectively prepare surrounding...

The Director, Quality Compliance and Audits (QCA ) reports to the Executive Director, Quality Compliance & Audits and provides strategic leadership and governance for Gilead’s global GMP and GDP audit program. This role leads and develops a team of auditors and ensures consistent, high‑quality audit execution across Gilead’s global manufacturing and supply network, including internal manufacturing facilities, external contract manufacturers, laboratories, suppliers, distributors, and other third‑party partners. The Director is accountable for oversight of the end‑to‑end audit lifecycle, including development and execution of the annual audit plan, and ensures audits are performed as systematic, independent, and objective assessments of compliance...

The Executive Director, Risk and Proactive Quality is a senior enterprise Quality leader responsible for defining, governing, and advancing the global strategy for Quality Risk Management and Proactive Quality across the organization. This role serves as the Global Business Process Owner (BPO) for Risk and has direct leadership accountability for the Change Control, Medical Device & Combination Product Risk, and Proactive Human and Organizational Performance (HOP) global process owners. This leader provides strategic direction and oversight to ensure that risk‑based thinking, proactive quality practices, and human‑centric performance principles are deeply embedded across the Pharmaceutical Quality System (PQS) and operations. The...

The Senior Director, Proactive Human & Organizational Performance (HOP) is a senior global Quality leader responsible for defining, governing, and deploying proactive quality approaches that strengthen human‑dependent processes and system reliability across the Pharmaceutical Quality System (PQS) and operations. This role serves as the Global Business Process Owner (BPO) for Proactive HOP, accountable for global standards, performance management, capability building, and continuous improvement of the Proactive HOP program. The role reports directly to the Executive Director of Risk and Proactive Quality and partners closely with other Quality GPOs, Local and Functional Process Owners, and site leadership teams to embed Human...

About the role As a Quality Control Analyst II, you will execute and review routine in-process, drug substance, and stability test methods in a timely manner. You will use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower). This shift will be working from Saturday to Tuesday. How you will contribute Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal). Conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability. Own and...

We are seeking a strong Full Stack Developer to join an AI-first, Agile product team supporting Global Regulatory Sciences (GRS). This role will develop and operate AI-native regulatory products, where large language models, agentic workflows, and data-driven intelligence are the default approach to solving business problems—not an add-on. The ideal candidate brings deep, hands-on software engineering experience delivering generative and agentic AI solutions in a regulated environment, with a focus on building production-grade platforms, integrations, and data-connected applications that can scale. Key Responsibilities Rapidly prototype AI solutions, validate hypotheses with users and data, and iterate from proof-of-concept to MVP and...

The Validation Engineer will play a critical role in ensuring compliance with all regulatory requirements and industry standards related to GMP asset management and validation in a regulated GMP manufacturing facility. This position requires a hands-on validation engineer with experience in GMP, an understanding of lab/manufacturing equipment, and a proven track record in validation processes. Key Responsibilities Establish validation protocols, risk assessments, and qualification plans to support GMP operations. Acts as a validation Subject Matter Expert (SME) providing support to multi-function teams, advises operations on validation matters, and potentially serves as the point of contact to present validation programs and...

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. As the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects. Serve as the primary liaison with FDA, for assigned products, on...

About Cell Therapy In Operations we turn molecules into medicine and are unified in our commitment to deliver more medicines to more patients more quickly. In essence, we are the critical link that brings innovation from our science labs to patients around the world. From our quality labs to commercial manufacturing, we share a common purpose to ensure our high-quality medicines reach patients when and where they need them, with the ultimate goal of improving their daily lives. We’re achieving all of this while continuing to accelerate our operational excellence through innovative science, Lean ways of working, and evolving digital...

Summary The validation engineer 2 works as an integral part of the validation team supporting new product introduction, sustaining manufacturing, computerized system introduction / sustaining. Collaborate in a dynamic team-oriented environment and lead the effort for defining, implementing and maintaining validation for manufacturing processes and systems. Become highly proficient in use of Validation Life Cycle Management System. Key Responsibilities Develops and articulates robust strategies for validation of processes/systems and generate validation plans Develops validation protocols for and oversee execution of IQ, OQ, PQ and manufacturing processes, systems and equipment in collaboration with end users and process owners Writes reports summarizing...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose The purpose of the Associate Director / Director, Global Medicines...

Quality Technician II This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer Technician II, you will support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership...

Abbott Nutrition in Casa Grande, AZ is seeking a Quality Engineer. The Quality Engineer is involved in all aspects of the manufacturing operation from assessing equipment needs, to documenting installation, qualification, and ongoing validation of equipment and processes. The Quality Engineer is also expected to assist in the identification and resolution of quality related issues and work with other areas to resolve issues. This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult...

About the role The Strategy Lead (Director) drives strategic planning for GLEC by translating senior leadership priorities into clear, actionable plans and measurable objectives. The role oversees annual planning, maintains strategic roadmaps, manages OKR/KPI frameworks, and supports operating reviews and governance processes. It includes leading strategic analyses, partnering with program and change management teams, and ensuring strong alignment, execution quality, and visibility across teams and regions. The Strategy Lead also serves as a strategic advisor to senior leaders, ensuring the function stays coordinated and focused on enterprise priorities. How you will contribute Lead all core annual planning workstreams, including calendar...

About the role The Learning & Development Lead (Director level) is responsible for creating and executing the global strategy to build both current and future capabilities across the Function. This includes designing an integrated learning roadmap that strengthens functional excellence, supports career development, embeds DE&I principles, and improves manager and team effectiveness. The role partners closely with GLEC Leadership, HR, Talent Development, and DE&I teams to ensure the Function is inclusive, high‑performing, and offers clear pathways for growth and advancement. How you will contribute Develop and own the L&D strategy and multi-year capability roadmap aligned to the Function’s priorities, risk...

Job Title Associate Quality Engineer We currently have an opening for an Assoc. Quality Engineer for the Vascular division. This role is located at our Westford, MA location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. WHAT YOU'LL DO Provide Process/Quality Engineering support to manufacturing and sustaining engineering teams, helping to ensure delivery of highest quality product to the customer. Participate in problem...

JOB TITLE Quality Systems Manager LOCATION 50 Northern Ave ., Boston, Massachusetts 02210 OPENINGS 1 DUTIES Collaborate with internal and external business partners and cross-functional teams to resolve complex quality and operational issues, ensuring compliant and efficient solutions. Draft, review, and maintain process-specific Standard Operating Procedures (SOPs) and Work Instructions to ensure they remain compliant and up to date. Analyze workflows, quality systems, and production processes to identify inefficiencies, compliance gaps, and areas for continuous improvement. Develop and implement effective solutions, encompassing enhancements to cross-functional quality systems and operational processes, ensuring adherence to industry standards and regulations...

General/ The Director, Clinical Quality Program Lead (CQPL) is responsible for the quality oversight across a range of study phases within assigned disease area(s) to ensure that trials are conducted in accordance with GCP requirements. The CQPL has oversight of real-time inspection readiness, risk management and quality health of programs in their assigned disease area(s). This position reports directly to the Senior Director of Global Clinical Quality (GCQ) and will sit on the GCQ Leadership Team. This position will have line management responsibilities. Key Duties & Responsibilities Partner with business stakeholders across Global Clinical Operations, Clinical Development, Regulatory, etc. for...

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position will oversee and partner with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. This position reports to the Shift Manager, Quality Assurance Shop Floor. This position works a rotating 2-3-2 Panama schedule (6am to 6pm) Day shift. Key Responsibilities Provide Quality on-the-floor oversight to Manufacturing/QC/Warehouse/ Packout operations. Identify departures from approved procedures & responding to complex issues independently and escalating critical issues...

The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation of the global regulatory strategy for CGT products of high complexity and visibility and may serve as Franchise GRL on complex programs with multiple indications. In addition to GRL responsibilities, the Sr RAD has the ability to function in dual capacity by also serving as a regional lead based on their location. The Sr RAD ensures that the regulatory strategy is designed to deliver efficient approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Senior Principal Quality Engineer – Design Quality & Systems Excellence role to be located at Danvers, MA. ABIOMED is redefining team-driven success while reshaping heart recovery. Here, new ideas are welcomed and encouraged, learning is constant, and our dynamic setting enables positive people to do profoundly important work. At Johnson & Johnson, we believe...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Software Design Quality Engineer II role to be located at Danvers, MA. The ideal candidate for the Software Design Quality Engineer II position will support various New Product Development and sustaining activities as well as play a role in product risk management, cybersecurity, change controls, and design controls. The engineer should have the ability...

Employer Medical Device Business Services, Inc. Quality Engineer II Job Code A011.10114.6 Job Location Palm Beach Gardens, FL Job Type Full-Time Job Duties Ensure manufacturing areas are meeting good manufacturing practices, international organization for standardization and any other applicable standards. Support day-to-day manufacturing operations in areas such as nonconformance review and evaluation, process verification and validation, process risk assessments, inspection methodology and acceptance criteria for inspection sample plans, root cause investigations, and collaboration on corrective actions (CAPA). Provide leadership in understanding QSR and ISO 13485 regulations, both within the Quality team and across other departments, and help represent Quality...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better...

The Associate Director, Operational Excellence – Internal Quality is a people leader who owns the vision, strategy, and operating model for Operational Excellence across Internal Quality. This role ensures strong strategy‑to‑execution alignment, delivering sustained improvements in compliance, efficiency, cycle time, cost, and right‑first‑time outcomes across Quality Assurance and Quality Control while maintaining inspection readiness and patient safety in a GxP environment. The role serves as the enterprise Operational Excellence leader for Internal Quality, aligning priorities to Quality and enterprise strategy, governing delivery, enabling the OE network, and ensuring measurable value realization across a portfolio of initiatives. This role will sit...

Senior Compliance Manager Strategic Mission The mission of Medical Operations Quality & Compliance (MedOps Q&C) is to be the best-in-class Local Quality organization that enables and empowers the U.S. Affiliate to do what’s right for patients by guiding the business through the medical quality and compliance and healthcare compliance landscape. We achieve this by leveraging our unique business, medical quality and compliance knowledge and fostering broad enterprise collaboration with key organizational partners to navigate the regulatory landscape while promoting a culture of quality and compliance. The Opportunity The Senior Compliance Manager is a specialized strategic advisor and key contributor within...

Senior Compliance Manager Strategic Mission The mission of Medical Operations Quality & Compliance (MedOps Q&C) is to be the best-in-class Local Quality organization that enables and empowers the U.S. Affiliate to do what’s right for patients by guiding the business through the medical quality and compliance and healthcare compliance landscape. We achieve this by leveraging our unique business, medical quality and compliance knowledge and fostering broad enterprise collaboration with key organizational partners to navigate the regulatory landscape while promoting a culture of quality and compliance. The Opportunity The Senior Compliance Manager is a specialized strategic advisor and key contributor within...

USE YOUR POWER FOR PURPOSE Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients. The Quality Compliance Engineer supports the Quality Organization by ensuring compliance with applicable regulatory requirements, company quality systems, and current Good Manufacturing Practices (cGMP). This role plays a key part in driving continuous improvement initiatives, leading quality‑related projects, and partnering cross‑functionally to strengthen compliance, efficiency, and inspection...

Director of Project Controls - Capital Planning, Engineering Project Delivery and Compliance What you will do Let’s do this. Let’s change the world! This role is a key leadership position within the Global Engineering Organization, supporting our aspiration to be Front Office for Operations. The Director is responsible for managing Amgen’s capital portfolio, ensuring consistent and compliant project execution, and advancing transformation initiatives aligned with Engineering’s strategic vision. This leader will drive cross-functional collaboration, align business priorities with investment decisions, and promote continuous improvement to maximize value delivery. This position will be located within driving distance from Amgen sites in...

Senior Manager, Quality Engineering - Minnetonka MN This position works out of our Minnetonka , MN location in the Electrophysiology business. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Senior Manager Quality Engineering , you’ll provide leadership and guidance for the quality engineering department supporting commercial products and new product development. This role is responsible for developing goals, objectives, procedures, policies, and systems that are in line with company goals and objectives, mission and...

Are you looking for a patient-oriented, innovation-driven role that inspires you and promotes your career? Then take your future in your hands and become part of our team as a Associate Director Clinical Program Quality This role combines global strategic influence with meaningful impact on patient safety, data integrity, and the successful delivery of complex clinical programs across multiple therapeutic areas. It offers you a unique opportunity to lead high-visibility inspections, shape risk-based quality strategy, solve complex challenges, and act as a trusted advisor to senior stakeholders while driving continuous improvement across the organization. How you will contribute Provide quality...

The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

PRINCIPAL OBJECTIVE OF THE POSITION The Senior Specialist, Validation Engineer II supports the successful implementation of manufacturing, and laboratory equipment alongside facilities and utilities at multi-use sites through interaction with internal customers and external service providers. The incumbent is tasked with qualifying new equipment, facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of low to moderate complexity. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve...

The Associate Director, Device Quality Assurance within Device Quality & Regulatory (DQ&R) is responsible for providing quality oversight of our Company's Device Network. This specific role is responsible for providing quality support for device assembly and packaging operations at our Company's Wilson, NC site and will be based on-site at Wilson. This role will serve as the primary interface between our Research & Development Division DQ&R and our Company's Wilson, NC site for the following aspects 1. Serve as on-site quality oversight for medical device and combination product operations which require above-site support Accountable for on-site Device Quality and Regulatory...

OBJETIVES Ensure the physicochemical quality of pharmaceutical products through relevant quality controls. Ensure compliance with applicable national and international standards and regulations, as well as internal quality standards. Promote a culture of continuous improvement, identifying opportunities for optimization in the laboratory's processes and procedures. ACCOUNTABILITIES Perform physicochemical analysis of finished drug products. Control stock of reagents, solutions and titrated solutions. Knowledge and management of laboratory equipment HPLC, Karl Fischer, dissolutor test, UV spectrophotometer, coagulometer, SDS-Page, ELISA, etc. Prepare solutions and reagents from the Quality Control lab. Verify analytical related documentation. Support the Analytical Services team in the development and transfer...

About the role As a Quality Assurance Inspector II, you are responsible for inspection activities for all chemicals and components used in the manufacturing process. You will ensure raw materials meet specifications and reject those that fail to meet quality expectations. How you will contribute Perform sampling of chemicals in a classified room using appropriate gowning and safety measures. Perform routine cleaning of classified room used for chemical sampling. Conduct physical analysis on incoming chemicals as required per material’s specification. Responsible for the quarantine and/or destruction of nonconforming materials. Responsible for inspection and release of production materials, components, and chemicals...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through robust QA processes and systems. Our approach is agile,...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. The Associate Director / Auditor, a member of the Quality Compliance and Audits (QCA) group, is responsible for providing independent quality oversight...

The Medtronic Clinical and Regulatory Solutions (MCRS) organization is seeking a Senior Program Manager to serve as the execution enablement lead for regulatory real estate initiatives, including site exits, consolidations, and footprint optimization. This role supports global real estate strategy by partnering directly with regional and local Regulatory Affairs (RA) teams , who retain execution ownership. The role accelerates progress by improving data readiness, structure, coordination, and early issue resolution—ensuring site exits with regulatory impact move forward efficiently and predictably. This role will partner closely with regulatory affairs professionals across the globe, especially in Europe and Asia. The individual operates...