Quality & Regulatory Jobs in Pharma & Biotech

Are you a cross-functional leader experienced with Pharmcovigilance and Auditing? We have an exciting opportunity to join our global team as a Quality Excellence Lead. The successful candidate will be instrumental in shaping quality strategies, providing data and delivering insights, with a focus on enhancing outcomes, productivity, and efficiency. The Opportunity At Roche, our commitment to quality in Pharma Development is unwavering. We aim to deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society. As a Quality Excellence Lead, you will play a pivotal role in driving excellence across our...

Senior Specialist, Cell Therapy Trade Compliance Location Gaithersburg, MD or Santa Monica, CA Introduction to role In AstraZeneca's Cell Therapy division, we follow the science to explore and innovate. We are working toward 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 worldwide. Our commitment to making a difference is driven by 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...

The Program Manager, Quality Strategy plays a critical role in driving alignment, communication, and execution of quality initiatives across the organization and enterprise. This role combines strategic planning, operational excellence, and representation to ensure the quality organization meets its goals and delivers improvements to metrics, processes, and collaboration. The Program Manager will act as a trusted partner to leadership, fostering communication and driving progress on quality strategies. This role is part of the Acute Care and Monitoring (ACM) organization, focusing on advancing quality processes and strategies to support innovative solutions that improve patient outcomes in acute care settings. The Program...

1) Review promotional material. 2) Perform regulatory evaluation of the change development project/engineering change orders. 3) Responsible for MDR recertification and maintenance. 4) Perform regulatory activities per UKCA requirements. 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, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking / control systems. Keeps abreast of regulatory procedures and changes....

A Day in the Life of a Principal Quality Engineer, Post-Market Risk Responsibilities may include the following and other duties may be assigned. Serves as Subject Matter Expert for Risk Management across the Post-Market space for their assigned product families Accountable for and owns the Risk Management Files for assigned product families Maintains Risk Management Files for assigned product families Conducts product Risk Analysis (PHA, RAC, SSRCI/System & Use FMEAs) in compliance with ISO14971 Evaluates product Risk Management Files against field data to ensure accuracy and correctness of predicted risks; validating pre-market Benefit Risk Analysis...

We are searching for the best talent for a Staff Quality Engineer to be located in Cornelia, GA and Athens, GA. 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 The Staff Quality Engineer is a seasoned individual contributor in a scientific/technology field. Conducts core initiatives for Quality Engineering schematics, detailed layouts, and subsequent comprehensive supply chain outputs, as well as associated key performance metrics, goals, and objectives. Works collaboratively with management...

We are looking for the best talent for a Senior Quality Engineer to be located in Cornelia, GA with occasional travel to Athens, GA. 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 You will be responsible for Determine quality standards and ensure compliance with industry regulations. Develop and implement quality control processes to ensure flawless production. Collaborate with diverse teams to identify areas for improvement and implement effective solutions. Conduct thorough product...

Use Your Power for Purpose At Pfizer, everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions will be instrumental in ensuring that our products meet the highest standards of quality and safety. What You Will Achieve In this role, you will Provide process validation troubleshooting support for all equipment/unit operations and processes on site related to Sanford’s...

Use Your Power for Purpose Our science and risk-based quality culture is not only compliant but also flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Your leadership and expertise will drive the strategic direction of your division, fostering a culture of continuous improvement and innovation. Your ability to leverage constructive relationships across divisions will help you maximize the resources available within the organization, ensuring that Pfizer is ready to achieve new milestones and help patients across the globe. What You Will Achieve...

The Clinical Study Quality Lead Senior Manager conducts quality assurance oversight and management activities of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols and Vertex policies and procedures. 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 quality issues and compliance metrics, investigation and CAPA management, and proactive inspection readiness activities. Key Duties and Responsibilities Serves as the Quality Lead for assigned clinical programs providing GCP compliance interpretation, consultation, and other...

to make a real difference in the lives of many About Lingo Abbott's rich history in developing cutting-edge health technologies is evolving with its new venture into b iowearables . The b iowearables segment is poised to represent the future of the organization, with the potential to generate over $1 billion in revenue within the next five years, supported by Abbott’s robust R&D and financial resources. At Lingo, we are committed to transforming health management with our cutting-edge biowearables that monitor glucose levels and other critical metabolic biomarkers. Our products integrate seamlessly with other health indicators such as sleep, exercise,...

Job Responsibilities Independently and proactively initiate and drive the planning, execution, and completion of change management projects Develop and implement strategies to mitigate risks within the change management process and change control system. Facilitate and present at cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS and regulatory expectations. Responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals. Develop, deliver, and improve the change management program for various levels of the organization, while also ensuring training...

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 The PR&D Quality Systems (QS) Team is responsible for...

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. Position The Quality Assurance Floor Support Specialist works as a...

The Director, Quality Risk Management will drive consistent Global Leadership on Quality Risk Management (QRM), the Risk Management Framework, Risk Posture considerations and provide support for key QRM processes within the GxPs (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP) across the Product Lifecycle. Accountable to drive QRM process optimization, integration, adoption and continuous improvement through capability building, key stakeholder engagement, digital enhancement, trend analysis of QRM data and guidance on authoring QRM procedures. Works cross-functionally to develop performance improvement initiatives throughout the organization by interacting and working with many great teams and leaders across the BMS network....

At Medtronic's Pyramid site in Memphis, TN, we are seeking a dedicated Quality Engineer II to join our team. In this role, you will be instrumental in developing and maintaining quality standards for our medical products. You will work closely with engineering and manufacturing teams to ensure that our products meet stringent quality standards. Your responsibilities will include designing inspection methods, conducting quality assurance tests, and performing statistical analyses to uphold product reliability and compliance. If you're ready to leverage your skills in quality engineering to enhance healthcare solutions, we encourage you to apply and become part of our mission...

Careers That Change Lives In this exciting role as a Senior Quality Engineer in Medtronic ’ s Surveillance process within the quality organization s , the incumbent will contribute to the Post Market Surveillance document writing process to ensure compliance to regulations and expectations of Regulatory Bodies. This is a scientific (engineering, technical, medical) writing position. This individual will partner with other teams such as Quality/Reliability, Clinical, Regulatory Affairs, Product Development, Medical Safety, and Statisticians to collaborate and execute tasks in a timely manner. Responsibilities may include the following and other duties may be assigned. Contributes and authors Post...

Medtronic – Milwaukee, WI manufactures spinal implants and Brain/ENT instrument components. In this exciting and fulfilling role the Quality Engineer will be responsible for providing quality support to the product value stream, ensuring that customer and patient needs are met every day. They will be part of a passionate team dedicated to ensuring our products meet the highest standards. In this role, the Quality Engineer II is critical in supporting key department metrics, which contributes to the global strategy while delivering on our mission to manufacture products of the highest quality that alleviate pain, restore health and extend the life...

Johnson & Johnson is hiring for a Sr Regulatory Affairs Specialist – Shockwave to join our team located in Santa Clara, CA or Remote. 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 more at...

Johnson & Johnson is hiring for a Quality Engineer II to join our Shockwave Reducer team located in New Brighton, MN . Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the innovative Shockwave Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina – long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide. To support the growing Shockwave Reducer business, we are establishing a facility in New Brighton, MN (SWMI-MN) focused on...

Johnson & Johnson is hiring for a Sr. Regulatory Affairs Specialist (Remote) – Shockwave Medical to join our team located in Santa Clara, CA and Remote US . 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...

Senior Associate Quality Assurance What you will do In this vital role you will be responsible for Plant Quality Assurance (PQA) On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements. This is an outstanding opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff, and also to provide coaching, guidance and direction to Manufacturing, Quality Control, and Facilities/Engineering staff regarding compliance and quality systems. This position works a rotating day shift, with five...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

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 Global Quality Compliance (GQC) Operations Associate will work in collaboration...

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. Responsibilities The Learning Associate – Learning & Development (L&D) supports the...

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our location in Irving, TX currently has an opportunity for a Customs and Trade Compliance Analyst . This new team member will provide technical and analytical support for customs and trade compliance matters at the site/division level, ensuring compliance with all relevant customs regulations and trade laws including, 19CFR, 15CFR, FDA,...

Quality Technician This position of Quality Technician works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine Division. The Quality Technician is responsible for bioanalytical and/or platform quality testing within the WWLIMS or QIMS system and SAP system. Provides inputs to facilitate CAPA investigations as required. Maintains product and testing inventory and complies with the quality system. Undertakes the role of a Quality Technician with minimal supervision. Redline documents and reviews operating procedures when needed. Execution of daily activities with minimal supervision. Accountability/Scope Individuals execute daily testing in a high-paced laboratory environment. Identify and...

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our location in North Chicago, IL (Lake County) currently has an opportunity for a Customs and Trade Compliance Manager. This individual will provide leadership and direction to ensure site compliance with all relevant customs regulations and trade laws and other US regulatory agency requirements. It will be the responsibility of this...

Are you a Pharmacovigilance auditor with an interest in performing risk assessments and developing quality strategies for assigned areas? Or are you a Pharmacovigilance expert who wants to gain auditing experience? If so, then this is the role for you! The Opportunity In Pharma Development Quality (PDQ) we strive for confidence in the integrity of our data and our processes, agility, and unrivaled transparency with health authorities, patients and society. Our work provides leadership, know-how and partnering on quality across Molecules, Products (Drug and/or Medical Devices), Pharma affiliates and global regulated processes. We are looking for a Quality Lead (Pharmacovigilance...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Clinical Laboratory Quality Control (QC) Associate (Tues - Sat and Sun - Thurs 1000am - 630pm) performs and functions within the Technical Laboratory under the guided direction of the Supervisor, Clinical Laboratory Quality Control Lead, or designee....

The Senior Analyst, Compliance Analytics, supports the creation, organization, execution and adoption of our Compliance Analytics Platform, including Office of Ethics and Compliance (OEC) Operations-specific dashboards, tools and systems, to manage and mitigate risk. This role is also responsible for informing, executing and adjusting the annual, US monitoring plans leveraging data analytics and performing data analysis to inform our on-going understanding of potential Compliance risks, and providing guidance for business led monitoring activities. Responsibilities Supports the end-to-end process to deploy global OEC Operations analytics and digital platforms, including defining business requirements, supporting design, executing User Acceptance Testing (UAT) and go...

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 Health Care

Accountabilities Quality Control Maintenance Planning - Retention of maintenance technical documents - Retrieval, filing, and archiving of preventive maintenance and corrective maintenance work orders - Review assigned SAP PM notifications and ensure complete and proper information is recorded - Convert and release assigned work orders (Corrective Maintenance and Preventative Maintenance) - Plan maintenance jobs for assigned areas ensuring coordination with area customers and area availability (includes Microbiology, Components, and Chemistry support) - Determine if work order needs SHE or QA review and approval; execute the review process - Create weekly work order schedule and participate in planning/scheduling meetings to monitor...

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. Aligned with our mission to alleviate pain, restore health, and extend life, we...

Medtronic – Warsaw, IN manufactures spinal implants and Brain/ENT instrument components. In this exciting and fulfilling role the Quality Engineer will be responsible for providing quality support to the product value stream, ensuring that customer and patient needs are met every day. They will be part of a passionate team dedicated to ensuring our products meet the highest standards. The Quality Engineer II role is critical in supporting key department metrics, which contributes to the global strategy while delivering on our mission to manufacture products of the highest quality that alleviate pain, restore health and extend the life of our...

Purpose Supports AbbVie’s global quality assurance function, suppliers and manufacturing sites for medical devices and combination products by providing in-house support to ensure product meets customer and regulatory requirements. This position supports the analysis and data collection for product or quality system issues intended to support continuous improvement. This position will also be involved in the support of regulatory inspections for medical devices and combination products. The employee must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources,...

The Sr. Manager, Risk-Based Quality Management (RBQM) plays a critical cross-functional role in ensuring the quality and compliance of clinical trial execution through effective monitoring oversight and risk-based strategies. This role is responsible for overseeing site monitoring activities and co-monitoring efforts, as well as contributing to centralized monitoring, quality trend analysis, and risk mitigation initiatives. This individual may serve as the regional monitoring oversight lead for assigned programs, supporting internal teams and CROs in aligning operational execution with risk and quality expectations throughout the clinical trial lifecycle. Here’s What You’ll Do RBQM Execution Support Support execution of RBQM strategies by...

Responsibilities Owns and drives all manufacturing NCRs, CAPAs, and customer complaints within assigned value stream. Supports audit readiness and on-site audits. Strong personal communications skills to influence other departments and individuals. Contribute quality and compliance expertise and guidance to teams responsible for addressing specific quality issues. Establish and support best practices for problem solving, root cause analysis, and solution selection tools. Tracks KPIs related to health of quality systems Support projects across the Strategic Engineering team to support engineering, data analysis, technical writing, and training activities Provide necessary support to ensure GMP compliance and other regulatory requirements are maintained within...

Engineer II Software Quality This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout division. What You’ll Work On Develop and conduct training of company personnel for the divisional software development and validation program. Work with Design and...

Director, Device Quality Introduction to role Are you a quality professional with significant expertise in Medical Device and Combination Product quality system requirements? Join us to ensure our quality systems, process and procedures remain compliant, scalable, effective, and efficient. Drawing on your experience across the full device product life cycle, you will enhance our approach to quality and quality management systems globally. You’ll lead initiatives that ensure continuous improvement, optimization, and maintenance activities of the device life cycle processes and be an SME partner across the business. Accountabilities Quality Business Process Owner for the device design process. BPO accountabilities include...

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 Johnson & Johnson is recruiting for a Senior Software Quality Engineer , located in Santa Clara, CA. Our team advances the MONARCH™ surgical robotics platform by providing quality engineering support and leadership for design of new products and design changes for commercial products. We collaborate on breakthrough medical technologies that unite multiple subject areas to improve patient outcomes and advance medical professionals’...

Sr. Quality Engineer will support day to day activities on manufacturing process. Support nonconformance investigations, audit process and CAPA process. Will oversee manufacturing and engineering processes to ensure proper use of tools, materials, and procedures. Developing and implementing quality control to analyze and improve existing systems. Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating...

We are seeking a strategic, experienced, and proactive Chief Compliance Officer (CCO) to lead and manage the global compliance and privacy functions for Medtronic Diabetes – a $2.8 billion medical device business that has recently announced that it will be spinning out into a standalone public company. Reporting to the company’s General Counsel, the CCO will be responsible for overseeing a comprehensive compliance program that ensures adherence to all applicable regulatory requirements, industry standards, ethical practices, and internal policies—across all regions of operation. The CCO will also lead the company’s global privacy team, ensuring compliance with global data protection regulations...

Join us at AstraZeneca in the Vaccines and Immune Therapies division as a Global Patient Safety Physician. This role is pivotal in our mission to provide long-lasting immunity to millions of people and directly impact the lives of populations around the world. We are at an exciting frontier of medicine, and we need your expertise to help us turn our ambition into a reality. Main responsibilities Working with the Safety Team, be responsible for the Clinical Safety strategy for assigned AstraZeneca- MedImmune drug projects and products throughout all stages of development and/or when on the market, including implementation and communication...

Position Description Perform procedures required for testing samples in compliance with current good manufacturing procedures (cGMP), safety and environmental guidelines, including clean room entry and aseptic procedures. Meet testing schedules, which may include working longer hours to complete testing and cleanup. Maintain accurate and compliant documentation. Assist in reviewing and updating current procedures for equipment and processes. Assist in planning, development and implementation of new procedures or special projects, resolution of testing issues by recommending solutions to issue or routes of investigation. Assist in cleaning and sterilization of equipment used in the department as well as cleaning work areas (including...

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...

Purpose The Manager, QA Audit and Compliance will perform evaluations for compliance with US and foreign regulation requirements (minimally may include the Americas, Asia, Africa, Australia, European Middle East regions) and provide constructive evaluation of quality related systems for suppliers that provide materials, services and products to AbbVie. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers and third party manufacturers. Their execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness and safety of...

Quality Technician II for Abbott SH, this position is based in Caguas, Puerto Rico. The Quality Technician II provides technical support to Quality Engineering by monitoring processes using statistical tools and analysis methods, tracking key performance indicators (such as yield or rework rate), dispositioning product per approved procedures, supporting Quality Engineers in the management of nonconformance events, executing quality related validations, performing problem solving to identify solutions to pressing issues, development process/tools changes to improve overall quality, among other quality roles tied to the performance, sustainability and improvement of manufacturing processes. The position works out of our Barceloneta...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Principal HR Policy and Compliance Manager is responsible for developing, implementing, auditing, and ensuring adherence with HR policies and procedures that have broad impact across the company. This role designs, maintains, and monitors HR policies and procedures...

As part of Global Labeling Strategy, and under the supervision of the Labeling Strategy Therapeutic Area Head for Inflammation and Rare Disease, the Regulatory Labeling Strategist is responsible for driving labeling strategy, developing, maintaining, and updating labeling documents, and supporting the facilitation and management of the end-to-end labeling processes for pre- and post-marketed products over the product's life cycle. In this vital role, you will author, enable internal governance reviews, and manage the development of the target product label, core labeling documents, and United States labeling for assigned products in accordance with the product strategy and Amgen labeling processes. Principal...

Position The Quality Assurance Specialist role is responsible for providing guidance and support to implement, execute, and oversee compliance and quality-related processes in accordance with applicable GMP requirements and our company's Animal Health Quality Systems. The position will assist engineering, material management, supplier quality management, and warehouse areas, and will provide overall support with quality audit (internal and external). Other expectations include Knowledge and experience in assessing quality impact and GMP requirements applicable to qualification and validation of highly complex engineering and IT projects related to pharmaceutical product Manufacturing and Quality Control. Work experience in supporting engineering and maintenance-related...

Sr. Specialist Quality Assurance Engineer - Williamson The Sr. Specialist Quality Assurance Engineer will onduct quality-related activities to deliver consistent; high quality documents; services; products and processes. This is a 5 days /week onsite opportunity based out of Alameda, CA. What You’ll Work On Defines project goals and milestones. Responsible for timely project completion. Provides solutions to a wide range of difficult problems. Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives . May lead projects with cross-functional or broader scope. Interacts effectively with employees, manager , and cross-functional peers. May represent own team while...

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 . Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom...

Purpose Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market. Responsible for assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetics Devices, etc. Responsibilities Primary driver for the quality and compliance aspects of Design transfer and on-market change management. Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and...

About the role The primary responsibility is to ensure compliance with procedures and regulatory requirements in the manufacturing facility. You are responsible for quality support and oversight of manufacturing operations, which includes presence on the floor and for performing Acceptable Quality Limit (AQL) sampling of finished product. Additional responsibilities include assessment for potential issues on the floor, raw material investigations, Quality on the Shop Floor (QOTSF), online batch documentation review, sample management, kitting of batches, and raw materials release. How you will contribute Perform Acceptable Quality Limit (AQL) sampling of finished product. Identify and assess quality risk in production operations...

Amgen, one of the world’s leading biotechnology companies, is investing $550 million to build a new multi-product drug substance bio manufacturing facility in Holly Springs, North Carolina, a bio manufacturing “hub” known for their life sciences industry. The new plant will combine two production formats, traditional stainless-steel fed-batch and single-use technology. This combination of capabilities is an approach that Amgen calls “FleX Batch” manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability, aspiring to embed industry 4.0...

Associate Quality Control What you will do In this vital role you will support the QC General and Immunoassay team by performing testing using GC (Gas Chromatography), BLE (Breakloose and Extrusion), Moisture Determination by Karl Fisher, Osmolality, Solid Phase Extractions with UV Spectometer. In addition they will support ELISA methodologies testing for HCP (Host Cell Protein) and ProA (Protein A) Impurities, qPCR, Density and Reconstitution Time. 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....

Quality Engineer II This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Quality Engineer II, you’ll have the chance to provide process/quality engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Also provide process/quality engineering support to product development teams, helping to ensure development of highest quality new products....

Regulatory Affairs Innovation Lead - VIE Contract Location USA, Cambridge Target start date 01/12/2025 iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28. PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship. PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to...

Purpose The Quality Control Planner is responsible for the oversight of QC Laboratory Planning and Scheduling within the Plant QC Group. Additional responsibilities may include short-term forecasting for enablement of efficient and effective laboratory scheduling, maintenance of laboratory planning and scheduling applications, evaluation and presentation of laboratory KPI's, and cross site harmonization of planning/scheduling processes. Responsibilities Maintains/manages laboratory planning/scheduling application, ensuring accurate configuration for laboratory workflows and timely prioritization of laboratory samples. Monitors, maintains, evaluates, and reports out laboratory KPI's. Collaborates with Laboratory Management to identify and implement process changes that enable continuous improvement. Participates in cross-site harmonization of laboratory...

Purpose Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of site leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QA Site Director. Responsibilities Manages the Quality Control (QC) laboratory including direct reports and budgetary responsibilities Member of the Laboratory Center of Excellence (COE) Serves as the standalone laboratory systems and site Maximo administrator Reviews and approves raw materials and commodities including ERP approval Exception Report (ER) investigation, writing, review, and approval including ensuring effective...

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. Preference for software-based regulatory experience or familiarity with software regulations and requirements. This position will be based in Mounds View, MN. The Principal Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Diagnostics products and External Pacemaker to market, provides advice on...

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...

Coordinates schedules and implementing activities for the Distribution function, that include overseeing personnel, directing operations and following-up on transactions, to ensure department standards and the Regulations are observed. Manages sterilization, returned goods, receipt, storage and transaction of finished goods in accordance with validated procedures. Ensures that customer orders are processed quickly and accurately to meet Division standards. WHAT YOU’LL DO As a Validation Engineer, you’ll have the chance to create and implement the Abbott Division validation program. Creates and maintains validation documentation for new and existing systems and processes subject to design control. Ensures that validation activities are implemented for...

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 Senior CQV (Commissioning, Qualification, and Validation) Engineer! This hybrid position will be located in Athens, Georgia! Are you interested in joining a team that is helping improve patient care and...

Johnson & Johnson is currently seeking a Staff Quality Engineer to join our exceptional team in Raynham, MA . 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 At Johnson & Johnson, we pride ourselves on our world-class products and our commitment to making a difference in the lives of people around the globe. As a Senior Quality Engineer, you will play a vital role in ensuring the quality of our...

Sr Manager Quality Assurance, Device Supplier Management and Oversight What you will do In this vital role you will program manage remediation of assigned critical external mechanical device suppliers. Lead a team of quality professionals overseeing external mechanical device suppliers Ensure compliance with scientific, regulatory, and quality standards across global operations Collaborate cross-functionally with teams in External Supply, Process Development, and Combination Product Quality Drive change, ensure product quality, and create a diverse and inclusive environment Monitor quality systems and performance of external device suppliers. Define and enforce quality requirements Manage supplier quality KPIs and risk escalations Manage and...

The Vice President of Central Quality Operations will l ead and influence Quality strategy for Gilead Global Quality Management System (QMS) and the design, implementation and delivery of systems and execution for GMP/GDP (Good Manufacturing and Distribution Practices) activities in the Global Markets organizations across every country in the world. Ensure the enterprise wide QMS structure, policy, standards and systems are fit for purpose across PDM, Commercial and other functional areas for the current and future direction of Gilead business needs, industry trends and regulations.. The r ole provides a significant impact across many areas as the QMS and Global...

The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients (API), biologics, vaccine drug substances and finished products. As Director, you will support Quality audits and health authority inspections and ensure any resulting corrective and preventative actions (CAPA) are effectively implemented. Primary Activities Serve as a subject matter expert for current good manufacturing practice (CGMP) requirements for vaccine and large molecule manufacturing Partner with our Company and CMO management to identify appropriate CAPA to address findings identified during audits and inspections. Monitor CAPA status and ensure...

Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The main function of the Associate Specialist, Quality Control is to assist in the assurance of the quality of product through the performance of microbiological, chemical and analytical sampling and assays as well...

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. S ummary of Job Responsibilities Quality Systems Ensure compliance with Good...

Purpose AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is committed to driving quality excellence across all stages of discovery and development for the product’s lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients. Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVie’s evolved business strategy are complex, rapid pace, and dynamic. Emphasizing and embedding quality in the...

This is an exciting opportunity to lead the Biostatistics efforts supporting Natera’s product portfolio of cutting-edge cell-free DNA screening tests. As Lead Biostatistician, you will leverage your medical device/assay development background along with your experience in applied statistics to oversee the design, analysis, and reporting of validation experiments to support our Women’s Health and Organ Health portfolio. The ideal candidate will possess strong communication skills and a deep understanding of biostatistics in analytical validation. PRIMARY RESPONSIBILITIES Study Design and Analysis Oversee the design, statistical analysis, and interpretation of analytical validation studies in support of Women’s Health and Organ Health product...

In this exciting and fast-paced role as a Principal Quality Engineer, you will have responsibility for providing quality engineering support for the manufacture of molded components used in implantable medical devices. This position is located at the Medtronic Energy and Component Center (MECC) Connectors Focus Factory. The MECC facility supports the design, development, and production of numerous components used in implantable devices for a variety of Medtronic businesses. Key aspects of this role include leading and/or supporting quality investigations, review and disposition of non-conforming product, establish statistical process controls, CAPA, collaborating with customer sites (downstream Medtronic facilities) on non-conformance investigation...

We bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to do 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. This is an onsite role located in Lafayette, CO. As a Director of Post-Market Quality based in Lafayette, CO, you will lead a team responsible for ensuring the safety, compliance, and performance of our products after they reach the market. This role...

Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies. You will provide commercial regulatory support for assigned brands, therapeutic area, and other projects. You may review and...

We are searching for the best talent for a Senior Regulatory Affairs Program Lead to support our Robotics & Digital Surgery team. The preferred location for this role is Cincinnati, OH however Santa Clara, CA is also available as a location . This role will work a Flex/Hybrid schedule with 3 days per week in-office. There is NO remote option . Relocation assistance may be available on a case-by-case basis. Purpose In joining our growing regulatory team, the Sr. Regulatory Affairs Program Lead will help Robotics & Digital Solutions reach US and international regulatory (NPD) approval goals. Under minimal...

The Quality Manager is a technical resource in the principles and application of quality assurance operations and compliance. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects. This is on-site job at the Leiden Center Key Duties and Responsibilities Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions. Lead the Working cell banks, intermediate and drug product dispositions activities. Perform change control assessments for the disposition and review batch manufacturing documents. Establish and revise the appropriate SOP's with...

This position works out of our Lake Forest IL facility. Reporting to the Global Privacy Officer for Diagnostics Divisions, this role is responsible for supporting the review and design of privacy controls, mechanisms and protocols across the organization and product line, and will support an important global digital transformation initiative. This team member will work cross-functionally with the Privacy, Legal, Compliance, Engineering, and Product Teams. The Privacy Program Manager must have experience with privacy by design, third-party vendor risk assessments, privacy impact assessments (PIAs), and compliance as well as overall operational and programmatic privacy experience. The successful candidate will have...

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 job At Lilly, we unite caring with discovery to...

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. U.S. Import Export Compliance (USIEC) is responsible for trade compliance oversight...

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, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi's Framingham Biologics facilities. QA's main responsibility is to ensure cGMPs are adhered to during manufacturing operations. Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety,...

Working at Abbott 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 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 plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to...

Job Title Quality Engineer II This position works out of our Alameda, CA office in the Lingo Division. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. This position is responsible for activities related to design control; qualification; specification and corrective and preventative action of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer...

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 unite caring with discovery to make...

Job Title Project Manager, Quality and Compliance This position works out of our Sturgis, MI 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 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. For over 70 years, Abbott’s Sturgis, Mich. , has been impacting its community while producing products that provide essential nutrition...

This critical senior position is responsible for leading the Commercial Quality Control team within the Commercial Manufacturing and Supply Chain Division. The incumbent will be responsible for leading a diverse team that is responsible for executing release and stability testing of all commercial programs across multiple modalities including small molecules, Cell and Genetic Therapies and Biologics. As well as leading established teams and platforms, the leader will be responsible for building new capabilities required for emerging pipeline assets and supporting routine manufacturing operations to ensure timely and quality products are delivered to patients. The team will be responsible for building...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer to be located in Horsham, PA. 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 Purpose The Senior Manager, Health Care Compliance Officer will be responsible for collaborating with Commercial and Medical Affairs on activities and...

The Sr. Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance. The Sr. Quality Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. The Sr. Quality Manager manages and develops personnel to support department and functional activities. Key Duties and Responsibilities Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions Participates in cross-functional teams as an experienced Quality technical resource Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed Assists Change...

About the role As the Senior Quality Complaints Specialist, you will ensure the quality of processes and product outputs by defining activities, processes, and standards. Your role will involve auditing, monitoring, and determining the quality of processes or outputs to meet internal and regulatory standards. You will support Takeda's mission by ensuring product integrity and compliance with quality requirements. You will report to the Complaints Lead. How you will contribute Define and specify activities, processes, and standards to meet quality requirements Audit, monitor, and determine the quality of processes or outputs Conduct product integrity testing to ensure compliance with quality...

Objective / Purpose The Head of Design & Delivery, Development & Regulatory will lead the global technical product strategy across Takeda’s development technology portfolio, encompassing Clinical Development, Regulatory Affairs, and Pharmacovigilance domains. This role is accountable for shaping and delivering innovative, compliant, and business-aligned digital solutions across the development lifecycle — from protocol design through regulatory submissions to post-market safety surveillance. You will lead a global team of product managers and work cross-functionally to ensure that Takeda’s development technology platforms are modern, scalable, and enable faster, safer delivery of medicines to patients. Accountabilities Define and execute the strategic product roadmap...

About the Role As a Quality Control (QC) Supervisor at Takeda, you will lead daily QC laboratory operations with a strong focus on microbiological testing, compliance, and process excellence. You will play a critical role in ensuring product integrity through method execution, investigations, and project leadership—directly supporting Takeda’s mission to deliver high-quality therapies to patients. This role will require hands-on microbiology expertise, method troubleshooting, and leadership in regulatory environments. How you will Contribute Oversee and execute routine and complex laboratory testing to support manufacturing operations, validation studies, and batch release—especially in microbiology. Perform and support microbiological methods such as Environmental...

Johnson & Johnson is currently recruiting for Quality Assurance Specialists (Two openings) ! This position is located in Wilson, NC. This role requires a fully onsite Monday-Friday schedule. 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...

The Principal Compliance Audit Specialist focus will be primarily medical device software, product security, and risk management. We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers. Responsibilities may include the following and other duties may be assigned. Must have experience and knowledge working with regulated medical devices and cybersecurity requirements. Manage and oversee internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

Senior Quality Analyst- Nights Takeda Pharmaceuticals About the Role You will perform all primary Quality Assurance activities for Teardown, Fractionation, and Purification following cGMP, GDDP, FDA and Regulatory Standards, ISO requirements, and internal standard operating procedures. The incumbent shall provide daily Quality on the Shop Floor oversight to manufacturing batch record and documentation review for accuracy and compliance to procedure, Quality on the Shop Floor walkthroughs to assure cGMP compliance and resolution of issues, participating in troubleshooting and problem solving of manufacturing issues and supporting daily Return to Operation assessment and Change Control (insignificant changes) process. You will provide Quality...

Quality Engineer II This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Quality Engineer II, you’ll have the chance to provide process/quality engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Also provide process/quality engineering support to product development teams, helping to ensure development of highest quality new products....

We are looking for our next Regulatory Operations Compliance Manager to join our team on-site out of our Maple Grove, or St. Paul, MN locations. This Compliance Manager, Global Regulatory Operations would be structured under Global Regulatory Services managing projects related to harmonized regulatory activities in the Abbott’s medical device division. As an individual contributor, the function of a Compliance Manager is to combine the knowledge of Regulatory, Quality and Compliance to manage implementation projects for emerging regulations and lead/drive quality compliance metrics for the Regulatory shared service organization. What You’ll Work On Lead procedural updates and emerging regulation implementation...

We are looking for our next Senior Regulatory Quality Specialist to join our team on-site out of our Maple Grove, or St. Paul, MN locations. This Regulatory Quality Senior Specialist position would be structured under the Global Regulatory Services (GRS) function managing projects related to harmonized regulatory activities in the Abbott’s medical device division. As an individual contributor, the function of a RA QA Specialist is to combine the knowledge of Regulatory, Quality and Compliance to lead and assist implementation projects for emerging regulations and supporting quality compliance related activities for the GRS department. With limited supervision, coordinates and compiles...

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 all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System,...

Shire Human Genetic

At Medtronic, we’re on a mission to alleviate pain, restore health, and extend life. As a Senior Quality Systems Specialist , you will play a critical role in ensuring compliance with global regulatory requirements while helping to continuously improve our quality system to support innovation and patient safety. This is your opportunity to apply your quality systems expertise in a collaborative environment where your work truly matters. As a Senior Quality Systems Specialist, you will Lead and support Quality System processes , such as CAPA (Corrective and Preventive Action), Internal Audits, Management Review, and Document Control. Serve as a subject...

The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities, and supports new/existing project initiatives. Key Duties and Responsibilities Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified. Supports change control assessments, implementation and closure Identifies and facilitates continuous improvement efforts Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed Helps represents Vertex Quality on cross-functional working teams, applying strong communication...

Johnson & Johnson is hiring for a Sr Regulatory Affairs Specialist, Ads/Promo Global – Shockwave to join our team located in Santa Clara, CA or Remote . 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....

The Director of Regulatory Information Management (RIM) leads the advancement of business capabilities to enable efficient, consistent, and compliant use, and management, of Regulatory information across AbbVie and with Health Authorities. Provides strategic design, implementation, and ongoing improvements of Regulatory business capabilities. Works closely with Business Process Owners across the enterprise to identify, prioritize, and deliver integrated processes involving Regulatory Information and supporting technologies in support of our broader AbbVie strategies. In addition, the individual has division level influence and is generally considered a key opinion leader and an expert resource both within AbbVie and externally. The individual may influence...

About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. The Sr Specialist Quality Systems within the Product Quality Assurance department is responsible for providing quality assurance support for the biologics...

As part of Pharma Technical Development (PTD) our organization is committed to deliver the Pharma ambitions by bringing game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance and Drug Product), clinical supply, formulation, device, packaging, and analytical development. Together with our partners, Global Biologics Bioprocess Development develops robust, efficient, and sustainable bioprocesses including Cell Line & Media Development, Cell Culture & Fermentation, and Purification Development. The Opportunity The Head of Process Validation, Tech Transfer...

This position will work M-F business hours, plus weekend on-call support About This Role We are seeking a highly experienced and motivated Senior Microbiology Manager to lead the microbiology function at our state-of-the-art biologics drug substance manufacturing facility. This role is critical to ensuring the microbiological integrity of our processes, utilities, and environment, and plays a key role in supporting GMP compliance and product quality. What You’ll Do Lead and manage the site microbiology team, including hiring, training, and performance management Oversee environmental monitoring (EM), utility monitoring (WFI, clean steam, compressed gases), and microbiological testing of raw materials, in-process samples,...

J&J MedTech is recruiting for a Primary Quality Engineer, New Product Development , located in Cincinnati, OH. 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 more at The Primary Quality Engineer is responsible for...

J&J MedTech is recruiting for a Senior Quality Engineer, New Product Development , located in Cincinnati, OH. 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 more at The Senior Quality Engineer is responsible for...

The position will be heavily involved in close partnership with Active Pharmaceutical Ingredient (API) manufacturing contractors and technical personnel and interacting with their functional equivalents in Quality Disposition and Pharmaceutical Research and Development and, Procurement on strategic objectives utilizing external contractors including Good Manufacturing Practice (GMP) qualification as well as site/project selection. Additionally, the incumbent would serve as the bridge between research and development, and Commercialization activities and develop strong working relationships with external quality management personnel. The incumbent would be the key quality representative attending and contributing to oversight and business review meetings with our company and contractor personnel...

AstraZeneca - Vaccines & Immune Therapies At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of people, where the burden of disease is greatest. During the COVID-19 pandemic, we played an important role as part of a truly global effort to respond to a new and unprecedented challenge. We will continue to advance science in vaccines and immune therapies and work with partners to drive improvements in public health and ensure our science reaches millions more people. Role The Senior Regulatory Affairs Director (SRAD) leads the global regulatory strategy for complex...

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. Moderna is solidifying its footprint in Madrid, a city that thrives on creativity and innovation. As a crucial...

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 Associate Director - Quality Engineering is responsible for demonstrating leadership,...

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. R esponsible for monitoring product performance, complaint investigations, and evaluating quality issues impacting released product R esponsible for Design Assurance activities supporting changes to commercial products. Mentor team members through technical problem solving including CAPA investigations and triaging issues. Provide technical...

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 plan...

This Regulatory Affairs Project Manager position is an onsite opportunity working out of our St. Paul, MN location in the Abbott Vascular Division. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. In collaboration with the Regulatory leadership, develop and implement regulatory strategies that will ensure earliest possible introduction of product(s) into domestic and international markets. Additionally,...

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 . Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great...

As the Quality Assurance Specialist III - Global Product Distribution & Affiliates , your key responsibilities will be Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as part of a QA team supporting Gilead’s global logistics operations. Serves as a project lead within the function or QA representative on cross functional projects. Maintains routine programs and processes to ensure high quality products and compliance with EU & FDA current Good Distribution Practice (GDP) and National Association of Boards of Pharmacies (NABP) Verified-Accredited Wholesale Distributors (VAWD) requirements. Supports Global and Regional QA teams as well as...

As the Associate Director, Quality Assurance - Global Product Distribution & Affiliates, your key responsibilities will be Serve as a key member of the QA Global Supply Chain team who are collectively responsible for implementation of cohesive & effective QA processes across the Gilead distribution network as well as developing medium and long-term strategic plans with our Global Logistics (Commercial & Clinical), and Supply Planning business partners, which support the overall strategic plans for the Supply Chain & Quality organizations. Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as part of a QA team supporting...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. This is a key role on the Shop Floor Quality Assurance team. As Shift Manager for the A2 Shift (6pm to...

We are searching for the best talent for Manager, Regulatory Affairs to support the Power Tools team within our Orthopaedics group. The preferred location for this role is Palm Beach Gardens, FL but candidates in Zuchwil or Oberdorf, CH will also be considered . This role will work a Flex/Hybrid schedule with 3 days per week on-site There is NO remote option . Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we...

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, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity, Collaboration, Innovation, Expertise. This critical role Covers all Lifecycle phases of pre-authorization to regulatory submission, submission to pre-approval inspection (PAI), PAI...

The primary responsibility for the Validation Specialist is the planning and overall approval of validation tasks. Under the direction of the Validation Section Manager, will participate in the implementation of the Validation quality program, but s/he will be expected to independently manage 5+ key projects simultaneously. May be expected to coach/supervise contractors and/or junior Validation Specialists This role serves to provide Quality Assurance oversight of site validation documents/ practices and reports up through the site Quality organization Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements Ensures that all...

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Manager Quality Control Support - Digital Laboratory Systems What you will do In this vital role you will...

People-centered, data-driven, connected. We're solving the world's biggest health challenges with healthcare technology. We fuse technology and research for groundbreaking solutions. From less-invasive surgery that minimizes a patient's downtime to the world’s smallest pacemaker, our technology transforms lives. At Medtronic, at our Warsaw production facility, also known as Warsaw Orthopedics, manufactures Spinal Implants and Brain/ENT components. Responsibilities may include the following and other duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications...

This position, Associate Director Regulatory Affairs , works out of our San Diego, CA location in the Infectious Diseases Division. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs. 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. We are seeking a highly knowledgeable individual to combine expertise in scientific, regulatory, and business issues...

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. Help us advance our purpose to make life-saving medicines that matter...

We are searching for the best talent for our Manager, MISE Vendor and Quality Management position to be located in Titusville, New Jersey. 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 The role Manager, MISE Vendor and Quality Management is responsible for developing and managing the quality...

Purpose This individual will be responsible for leading and supporting Quality Risk Management (QRM) activities for AbbVie products such as Combination, Pharmaceutical and medical devices. Support the strategic direction to ensure business objectives are met to support and sustain the Quality System in compliance to Quality Risk Management regulations, guidance’s and standards. Responsibilities Drive Quality Assurance activities to develop, implement and sustain required QRM regulations and standards to comply to global requirements. Assure proper integration for AbbVie products such as device, combination, drug and biologics regulations. Areas of direct responsibility include development and maintenance of QA procedures for risk management...

Position As the Director, IT Computer System Validation & Quality Assurance, you will play a pivotal role in ensuring the compliance, reliability, and quality of our computer systems within the biotechnology domain. This position offers a unique opportunity for an experienced professional to lead and make a significant impact on our company's success. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Millbrae, CA office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration....

For over a decade, Medtronic has been at the forefront of transforming stroke care, leading the fight against both acute ischemic stroke (AIS) and hemorrhagic stroke. By equipping physicians with innovative technologies, we empower their expertise to improve patient outcomes and redefine neurovascular care. Our commitment extends beyond medical device development—we actively collaborate with the medical community to drive meaningful advancements in stroke treatment. Together, we are changing the way stroke is managed worldwide, making a lasting difference for the millions of patients affected every day. Click here to learn more about Medtronic Neurovascular brain treatments and therapies. #Neuroscience Join...

This position works out of our Liberty, SC location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. We are seeking a high caliber Sr. Quality Engineering Technician who will work under general supervision, builds routines for non-contact inspection equipment to support incoming inspection activities. Interprets drawing & blueprint requirements and applies test or inspection methods to verify requirements. Performs tests according to written protocols; adjusts incoming inspection plans to support supplier quality engineering; maintains accurate...

Manager of Customs & Trade Compliance Our location in Lake Forest, IL , currently has an opportunity for a Manager of Customs & Trade Compliance . This role will provide leadership and direction to ensure site compliance with all relevant customs regulations and trade laws and other US regulatory agency requirements. It will be the responsibility of this position to develop a staff of experts in the import/export compliance field that will serve the current and future demands of the supply chain operation. What You’ll Work On Manage import/export process and develop effective internal controls to ensure site compliance...