Quality & Regulatory Jobs in Pharma & Biotech

This position will work NIGHTS from 6 PM to 6 AM on a 2-2-3 rotation schedule About This Role The Senior Quality Associate I is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral Facility. Specifically, this role will have primary quality oversight of the following activities (1) Shop floor support ensuring critical steps are executed according to batch record and procedural requirements, (2) Exceptions review and approval and (3) Respond to operational needs that require QA approval. What You’ll Do Ensures Product documentation and other...

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...

SR. ASSOCIATE QUALITY ASSURANCE - INSPECTION What will you do? In this role you will ensure the integrity and compliance of materials and processes that support the delivery of high-quality, life-impacting products. You’ll provide QA support in a Non-Standard Shift Operations environment that may include weekends and/or nights ensuring products meet the highest standards of compliance, safety, and quality. Specific responsibilities include but are not limited to Perform inspections, testing, and release activities independently, ensuring strict adherence to SOPs, cGMPs, and safety protocols. Apply subject matter expertise in materials and production processes to identify quality issues and ensure compliance. Accurately...

The Senior Quality Specialist will provide QA support for manufacturing operations, analytical laboratory operations, and materials management for the internal programs at Vertex Manufacturing Center (VMC), Boston, MA. The position will be a part of the QA operation floor support team. This role will review & support activities related to product disposition, including batch data, batch records, deviations, in-process data, EM data, QC release testing, and other quality systems documentation. The Senior Quality Specialist supports or executes daily activities related to equipment or instrumentation supporting Facilities, Utilities, Manufacturing, and Labs. The position will support multiple production functions (from Quality operations...

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...

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 An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for a Quality Inspector I to be in Danvers, MA. Job Summary The Quality Inspector I will perform basic inspections and sorting of incoming materials, parts/components. Provide support as needed to the Operations group. Duties and Responsibilities Perform inspections of...

The Regulatory Affairs Director (RAD) , Global Regulatory Strategy will be responsible for the development and implement ation of global regulatory strategies for all assigned products and therapeutic areas, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will, with a high sense of urgency, lead cross-Regulatory teams and be accountable to provide key regulatory input to Global Program and/or Medicine Teams (GPTs/GMTs) deliverables . The individual will also ensure effective communication and constructive working relationships with business partners and representatives of...

We are recruiting for a Regulatory Affairs Specialist I to join our team on-site in Sylmar, CA or Scottsdale, AZ . As an individual contributor, the function of a Regulatory Affairs Specialist I is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for US and international registration assessments. What You’ll Work On Annual Reports – FDA APRs, ARCs (support), Custom Devices, Ics (support)...

Senior Development Quality Manager This position works out of our Menlo Park, CA location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. We are seeking a passionate Senior Development Quality Manager to lead and develop an engineering team responsible for operations quality, design changes, transfer projects, and post-market surveillance within assigned product areas. The manager will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring...

Quality Manager, Enterprise Systems As a Quality Manager, Enterprise Systems , you will be responsible for planning, directing and coordinating quality and enterprise systems programs within Abbott’s Rapid & Molecular Diagnostics (RMDx) Infectious Disease (ID) business unit. This role is chiefly focused on business and stakeholder engagement, business and enterprise systems change management, strategic planning, communications and Quality program delivery. The Quality Manager, Enterprise Systems will champion the Quality function ensuring that the ID QA initiatives are aligned to business strategy. This role will interact with divisional leaders, RMDx shared service leads, BTS Business Relationship Managers and IT...

Pfizer Sanford provides Drug Substance and Drug products to facilities around the globe. This position will write, or support the development of, various technical documents such as standard operating procedures, executable electronic forms, specifications, and business guidance documents. The candidate will assist in Pfizer's digital revolution by representing the department in transformation of protocols, plans, reports, forms and other documentation to electronic documents. Additionally, the candidate will help lead continuous improvement projects within the validation department. As an associate, your focus on the job will contribute to achieving project tasks and goals. Through your domain knowledge and commitment, you will...

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 Staff 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’...

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 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 recommend focusing...

Johnson & Johnson is currently recruiting for a Senior Manager, Quality Systems! This position can be located at any US/PR J&J site with a preference for Horsham, PA, Titusville or Raritan, NJ. Senior Manager External Quality, P&O is the EQ Global Process Team Leader for assigned Quality System(s) Manages day-to-day proactive and effective quality processes and systems within the External Quality (EQ) Processes & Operations to support external manufacturing globally. Ensures EQ is in full compliance with regulatory, industry and Johnson & Johnson Supply Chain requirements and standards. Resolves planned and unplanned issues regarding compliance, quality systems and training....

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. Exact Sciences Corporation seeks Quality Engineer II in Madison, WI. Job Duties Participate in requirements, design and review meetings. Participate in development of test strategy, test plan, test cases, and risk assessment leading to successful implementation and timely project...

As a Principal Regulatory Affairs Specialist at Medtronic, you will play a critical role in shaping the global regulatory strategy for innovative medical technologies. You will provide strategic input and technical guidance to ensure our products meet evolving domestic and international regulatory requirements. This high-impact role involves leading regulatory submissions, maintaining compliance, and driving collaboration across teams to support product development and lifecycle management. Your expertise will directly influence patient access to life-changing therapies worldwide. Key Responsibilities Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering global regulations. Lead or perform coordination and...

A Supplier Quality Engineer collaborates with a diverse network of suppliers to resolve quality challenges affecting production. This role involves working closely with the production team to promptly address issues and drive improvements in component quality. The engineer will play a key role in establishing quality standards for suppliers, enhancing quality system programs, and partnering with cross-functional teams to execute qualification projects. Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and...

Quality Assurance Senior Manager What you will do This QA Sr. Manager role will be responsible for the quality oversight of primary component suppliers. This person is an integral member of the Amgen cross-functional supplier team(s) that includes, but is not limited to, business operations, process development, supply chain and combination product quality. Key Responsibilities include Ensure appropriate quality oversight of suppliers in line with global regulations, define quality requirements for suppliers and monitor performance Quality liaison between Amgen and the supplier Negotiator and owner of quality agreements Prepare external site for inspections including development of inspection playbooks....

The Regulatory Diagnostics Manager (RDM) for Precision Diagnostics is responsible for implementation of strategic plans for development of diagnostics, including companion diagnostics (CDx), as they pertain to the Novartis innovative medicines portfolio, including its marketed products. The RDM works with oversight of senior members of the Regulatory Affairs Precision Diagnostics Team including the TA and Diagnostics Lead on strategies and submissions including companion diagnostics, in close collaboration with internal RA Disease Unit associates, associates of Digital, Data and Clinical Innovation (DDCI) at Novartis as well as Partner Companies that develop diagnostics and ensures adherence to regulatory requirements. The RDM will...

Lead global regulatory strategy and execution for our innovative biologics/combination product portfolio. As Sr. Director of Regulatory Strategy, you will shape and drive regulatory pathways from preclinical through commercialization and lifecycle management. This key leadership role combines strategic oversight of registration requirements, regulatory submissions, and health authority interactions across markets. The ideal candidate brings deep expertise in global biologics regulations, with demonstrated success in navigating complex regulatory landscapes for combination products. Join our dynamic team to advance breakthrough therapies while ensuring regulatory excellence and compliance across all stages of drug development. The ideal candidate will live in the San Diego...

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

Quality Compliance Manager What you will do Let’s do this! Let’s change the world! We are hiring a Quality Compliance Manager, which will operate within the General Medicine & Obesity Quality Therapeutic Area. In this vital role you will provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program. (protocol development, database lock, and regulatory submissions/ approvals). Reporting to the Quality Compliance Associate Director, you will oversee quality management and ensure compliance for global and local clinical trials by supporting...

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...

Johnson & Johnson is hiring for a Principal Quality Systems Specialist – Shockwave Medica l to join our team located in Santa Clara, CA. 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 Manager Distribution Quality Operations p rovides oversight and support for quality compliance of BMS products at 3PL distribution centers (DCs) and during transportation between facilities. Ensures that BMS quality compliance expectations are met and maintains inspection readiness. Collaborates to develop quality strategies for storage, transportation, and distribution of products. Key Responsibilities Serves as primary DQ USPR contact and provides quality oversight/support for the Manchester, PA USDC and BMS Puerto Rico’s 3PL DC. Reviews and approves change control documents related to storage, transportation, and distribution of products. Supports product launch preparation and activities. Conducts pre-approval assessments and other regulatory...

A Day in the Life Medtronic is currently searching for a Principal Quality Engineer to join the New Product Development team at the Lafayette, CO facility. You’ll play a crucial role in supporting our Surgical business unit by ensuring that our suppliers deliver high-quality parts, materials and service. You will also participate in design transfer and manufacturing quality activities. Key Responsibilities Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services. Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems. Experience with PCBA suppliers and validation of PCBA test...

Medtronic is a world leader in providing health care products that restore health and extend life. The Medtronic Diabetes R&D team contributes directly to this mission; we deliver software and firmware for Medtronic’s pump and continuous glucose monitoring devices. Our business is growing significantly as the market demands reliable medical devices which look and feel more like consumer devices. We are looking for an Associate Quality Systems Specialist who can help us continue to make devices more robust and reliable for our patients. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention...

We are looking for a skilled and detail-oriented Quality Tech III. This role is a critical part of our operations, responsible for environmental monitoring and testing/labs. Responsibilities may include the following and other duties may be assigned. Reviews sterilization and microbiology test records for accuracy and completion as a part of sterile release process Performs microbiological testing in laboratory and controlled environments Reviews and approves test reports Coordinates shipping of test samples to contract laboratories Maintains inventory of laboratory supplies Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to...

About Synchron Synchron is a neurotechnology company with a mission to deliver the first commercially scalable brain-computer interface (BCI) for millions of people with paralysis to reconnect with the world. Our minimally invasive BCI system is designed to enable users to control digital devices directly through thought, restoring access and control over the digital world. Our team is working at the intersection of healthcare and technology to translate breakthrough research into real-world care. Join us in shaping a more connected and accessible future. As a Quality Assurance Engineer in our newly formed division in San Diego, CA, you will...

The Senior Regulatory Program Manager will manage implementation regulatory activities of Robotics Surgical Technologies (RST) portfolio. The mission of Global Regulatory Affairs is to influence the regulatory environment, develop innovative strategies for regulatory approval and post-introduction requirements, and anticipate and respond to changing requirements in order to benefit the patients we serve. Location Strong preference to have a candidate work from Lafayette, CO, Boston, MA, North Haven, CT, or Mounds View , MN. Will consider candidates to work from another MDT facility in the U.S. or work remotely within the U.S. Travel 25% Responsibilities may include the following and other...

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. The Senior Specialist, QC Compliance, Cell Therapy is responsible for leading QC deviation, laboratory investigations, CAPAs and change control. May provide...

Provides Regulatory Strategy support for the preparation of and coordination of document packages for regulatory submissions. Conducts review of regulatory documents. Maintains various regulatory databases and document tracking systems. Under direct supervision, may act as Regulatory Strategy department contact for various internal projects or program activities. _ Your Contributions (include, but are not limited to) Under direct supervision, assist with preparation ofsubmissions to regulatory authorities (e.g. clinical trial applications, IND/IND supporting documents and maintenance submissions, annual reports, expedited safety reports) Conducts review of clinical regulatory documents. Performs quality checks of submission documentation and publishing output Updates and maintains logs, databases...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Senior Associate – Specialist, Global Regulatory Affairs CMC role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows With supervision , support the execution of regulatory CMC investigational , registration and post- approval strategies...

Our company is expanding its global Bacillus Calmette Guerin (BCG) vaccine production by adding an end-to-end laboratory capability located in the Durham, NC campus. The new facility will be used to produce the bulk active ingredient, finished product, and laboratory testing for the BCG vaccine. The Specialist, Quality Control participates in a team of analysts in the development, validation, and routine testing for the BCG Product. The position will focus on environmental monitoring, aseptic process simulation and support testing readiness in preparation for commercial production. The selected candidate will participate in equipment validation, process validation, and GMP laboratory readiness. The...

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. Sanofi, an integrated global healthcare leader , discovers, develops and distributes therapeutic solutions focused on patients' needs . Sanofi has core strengths in the field of healthcare with seven growth platforms diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, and animal health . The Compliance Specialist will be...

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. This position supports the execution of routine and non-routine testing in the QC Virology PCU to ensure the safety, potency, and purity of biological products in compliance with Federal Regulations, cGMP, and Sanofi policies and procedures. This position requires the individual to compliantly perform viral assays as scheduled, analyze results,...

Senior Specialist Quality Control – Technical Resources What you will do Let’s do this. Let’s change the world! In this vital role you will be the technical specialist for Amgen Manufacturing Limited, QC Operations. You will serve as a key technical leader supporting the Quality Control (QC) laboratories. You will be responsible for addressing complex technical challenges with cross-functional, multi-site, and external impact. Collaborating across Quality Control, Quality Assurance, Manufacturing, Engineering, and Process Development, your work will be critical in ensuring the robustness and reliability of lab operations. Specific responsibilities include but are not limited to Technical Expertise & Troubleshooting...

Director- Site Quality Head The Opportunity Abbott Diabetes Care has an opportunity for a Director - Site Quality Head. The Director leads strategy, management and support for global supplier quality associated with the division. Areas include suppliers (parts and services), Third Party Manufacturers (TPM), and Original Equipment Manufacturers (OEM), service providers and consultants. Establishes quality systems and plans for supplier controls to assure design, development and manufacture of the highest quality products to exceed customer requirements. Interfaces with outside regulatory agencies. What You’ll Work On Champions quality and compliance through awareness of requirements, trends and other external influencing factors especially...

Job Title Software Quality Engineer II Our location in Sylmar, CA currently has an opportunity for an Software Quality Engineer . This is a fully onsite role . This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for non-product software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. 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. WHAT YOU’LL DO Provide guidance and training to the...

R2814855 Regulatory Site Office Manager Location Swiftwater, PA About the Job 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. The Regulatory Site Office Manager, Vaccines will work closely with the Manufacturing and Supply teams, and CMC colleagues on the regulatory assessment of Vaccines site-based projects to achieve submissions and approvals in key markets and to maintain regulatory compliance...

This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. We are seeking a passionate Manager in Quality Engineering to lead and develop an engineering team responsible for operations quality, design changes, transfer projects, and post-market surveillance within assigned product areas. The manager will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products...

Medtronic has declared its bold ambition to become the global healthcare technology leader. By doing so, we seek to reach more patients in more meaningful ways, more quickly. Are you looking to create capability and competencies in Operational Excellence (OpEx) for the leader in the Medical Technology industry? As the Operational Excellence Sr. Manager, Transactional Processes, you will be a core member of the team representing Operational Excellence to plan and execute process improvement objectives supporting the Global Quality organization. These objectives include specific operational performance targets as well as the development and training of employees to create a sustainable...

Purpose The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant. Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks...

We are searching for the best talent for a Manager, Health Care Compliance to be based in Santa Clara, CA; New Brunswick, NJ; Raritan, NJ; West Chester, PA; Irvine, CA; or Danvers, MA. Purpose The Healthcare Compliance Manager will support Shockwave Medical, and play a key role in ensuring the Company meets statutory and regulatory requirements relating the health care fraud and abuse; as well as advertising and promotion laws governing commercial and scientific activities. This role will also support Shockwave’s health care compliance integration activities. You will be responsible for Partner with business and functional stakeholders and provide compliance...

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 and Johnson is seeking a Senior Investigation Quality Leader, located in Athens, GA. The Senior Investigation Quality Leader is responsible to ensure the generation and completion of robust investigation reports (i.e Nonconformance and Root Cause investigations). This includes,...

Senior Manager/Associate Director, Regulatory Medical Writing X-TA At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. 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 is currently recruiting for a CAR-T Specialist 3, Quality Assurance Microbiology. This position will be located in Raritan, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at [CAR-T is...

About Vision Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime....

As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment. The individual may execute tasks and partner across business functions. The individual will be reviewing Labeling, Advertising and Promotional materials, determining risk, identifying data needed, obtaining data and ensuring that the information is reliable and effectively presented to substantiate claims. You'll also have opportunities to participate in worldwide regulatory submissions. This is a broad scoped position with strong opportunity for growth and career development based on performance. What You’ll Work...

Position We are seeking an experienced Senior Manager to Associate Director, Regulatory Affairs, to manage our regulatory clinical trial applications (CTAs) and compliance efforts. In this critical role, you will be responsible for ensuring that our biotechnological innovations align with all relevant regulations and standards. You will collaborate with cross-functional teams to develop ex-US CTAs, and manage the maintenance of applications submitted to Competent Authorities (CAs) in support of study initiation. This role is a member of the program teams within the function of Regulatory Affairs.This role will require a minimum of 3 days a week of onsite presence (or...

About the role As Senior Validation Engineer, you will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. You will report to Head of Engineering Services. This is an on-site position, and you will be required to work all five days from the office. How you will contribute Be a Validation Engineering representative and technical subject matter expert (SME)...

Primary responsibilities are routine testing and verification of print and imaging of labels, product inserts, carton materials, foils, etc and their review / release to production. This includes proofs, first prints, and reprints and documentation in a GMP laboratory. Additional responsibilities include entering data into SAP, training to become proficient in drafting investigations, working directly with vendors to correct component deficiencies and improve vendor processes, updating standard operating procedures, trains and learns to coordinate launch activities around print activities around printed material, and approve artwork in our global LIMS system. Testing equipment utilized include but are not limited to Text...

This position works out of our Plymouth, MN location in the EP division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As a Staff Quality Engineer, you'll have the chance to be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What You’ll Work On Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or...

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 getting a bachelor’s...

Provides leadership & strategy for a group of IT professionals supporting a major organizational unit responsible for the definition, development, implementation, operation and support of computer-based systems and related processes and tools which provide information for reporting, operations, and decision making for the Quality Non-Complaints, LMS (Learning Management), DMS (Document Management), and Global Engineering Systems (GES) within the Quality-Regulatory-Engineering Services BSS Organization. What You'll Work On Creates and manages Corporate Quality Non-Complaints, LMS, DMS & GES Strategies and Architectural Framework in partnership with Divisional BRM’s Aligns department priorities appropriately, determines critical success factors, evaluates and pursues initiatives, investments and opportunities...

As Senior Analyst, Data Quality, you will join our Commercial Data Management team and become a key contributor in building scalable quality control processes and partnering closely with cross-functional teams to ensure our data is trusted, accurate, and business-ready. This is an exciting opportunity for a detail-oriented, analytical thinker who enjoys tackling complex data challenges, working collaboratively across teams, and utilizing cloud data technologies to make a significant impact in a pivotal position. Your responsibilities will include the following activities _ Your Contributions (include, but are not limited to) Execute recurring quality control checks on commercial datasets including sources such...

Careers That Change Lives In this exciting role as a Sr Quality Engineer you will Witness cutting edge surgical navigation and robotic technologies designed to alleviate pain, restore health and extend life. Representative and/or Lead for the New Product Introduction ( NPI ) Quality team on the NPI Core Team on small to medium size project s . Compliance oversight over the medical device NPI activities in accordance with the applicable Standard Operating Procedures (SOP's) and External Standards as part of the NPI process. Contribute and lead activities during the following activities Risk analysis, including product risk a ssessment...

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 for the chemical or physical property. Performs a variety of qualitative tests or qualitative assays on samples, and to aid in maintenance and certification of test instruments and apparatus to ensure compliance. Performs required inspections, checks, analysis and documentation of studies. Prepares and monitors quality statistics and reports. Reviews production records for conformance to procedures. Conducts...

Careers that Change Lives A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people . Help us engineer the extraordinary! Bring the next generation of life-changing medical technology to patients worldwide. We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. Learn more about Medtronic benefits and compensation at the bottom of this job description. We...

ASSOCIATE QUALITY CONTROL- GELS LABORATORY What you will do Let’s do this. Let’s change the world! In this vital role you will be responsible for one or more of the following activities analytical testing, method development, routine sample testing, and data management. This role is a key contributor within the Quality Control department and supports non-standard shift operations, which may include first, second, third, and/or weekend shifts. Specific responsibilities include but are not limited to Conduct routine laboratory testing using techniques such as SDS Page, IEF, Capillary Electrophoresis and Elisa in accordance with SOPs, compendia, and analytical methods. Operate laboratory...

The Quality Systems Senior Specialist is responsible for providing quality assurance support for some or all of the following manufacturing processes pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations. This role is part of the External Quality Assurance (EQA) team responsible for product quality across a portfolio of topical skincare products that include Natural...

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...

The Senior Design Quality – Electronic Engineer position, is one of development, improvement and innovation. If you pride yourself on your problem-solving skills and a meticulous attention to detail this may be the role for you. You will be tasked to provide quality engineering support in the design and development of electronic medical device products. Facilitate the application of Design Controls, Risk Management and Change Control processes in the evaluation and implementation of changes to released products. Responsibilities may include the following and other duties may be assigned. Previous experience in Electronic PCB design and development. Preferably with a formal...

Role Senior Design Quality Engineer The Design Quality Engineer position is one of development, improvement, and innovation, through cross functional collaboration. If you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you. You will be tasked to provide quality engineering support in design and development of medical device products across the Acute Care and Monitoring [ACM] portfolio of products. Facilitate the application of design controls, Risk Management and Change Control processes in the evaluation and release of product changes. As our Senior Design Quality engineer, your Key Accountabilities...

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

At 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. Eli Lilly and Company seeks a Regulatory Affairs Director (R7-R8) 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. The Deviation Mentor is a key member of the Quality Assurance...

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. Eli Lilly and Company seeks an Advisor, Global Quality Labs (R5)...

This position is responsible for providing investigation technical support, supplier process improvement, and scientific expertise and compliance knowledge to fulfill BMS requirements to implement supplier changes. Applicants must comply with Corporate and HR Policies, Security Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function Duties/Responsibilities Perform investigations, using eQMS (Infinity) system, for Supplier Complaints including but not limited to BMS and Supplier’s processes. Create and execute Corrective Actions and Preventive Actions (CAPA) Prepare, submit and discuss finding of the investigation process with key stakeholders. Lead global investigations in collaboration with Global Quality Supplier...

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

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

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

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. KEY RESPONSIBILITIES The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. This position will ensure “right first time” global approvals of CMC regulatory (Biologics) submissions,...

Key Responsibilities Lead strategy and execution of complex sterile product qualification activities. Expertise in contamination control, cleaning validation and isolator systems. Adopt best practices for continuous qualification of sterile production facilities. Provides relevant CMC support for sterile products pre- and post-approval filings. Interface with Senior Leadership Team to provide a unified set of goals and objectives for the Validation team. Assist with onboarding of new technologies and provide oversight for new qualification programs. Work with Quality to adopt an effective quality management system and achieve the quality objectives. Provide leadership for Validation team and ensure growth and development of staff...

GCP Quality Compliance Manager What you will do Let’s do this! Let’s change the world! In this vital role you will provide critical support to the Process Quality function by assisting in the implementation, monitoring, and continuous improvement of Amgen’s R&D Quality Management System (QMS) and Regional Quality Oversight. Accountabilities Assist in maintaining and improving the QMS by helping to track, document, and implement quality initiatives, ensuring that procedures and processes meet regulatory requirements. Contribute to the collection, analysis, and reporting of quality metrics (KPIs, KQIs), helping to identify trends, risks, and areas for continuous improvement. Provide hands-on support to...

We anticipate the application window for this opening will close on - 20 Oct 2025 Position Sr. Supplier Quality Engineer for Medtronic, Inc. located in Minneapolis, MN. Responsible for communicating technical objectives between Medtronic and suppliers. Coordinate with cross-functional groups in supplier selection process. Developing and maintaining incoming inspection procedures, ensuring inspector trainings and qualifying parts for SOQ program. Responsible for Supplier Change process between Medtronic and Suppliers to evaluate and implement changes at Supplier. Responsible for Supplier and Medtronic CAPA (Corrective and Preventive Action) Supplier related Product and Process NCMR (Nonconforming Material Report) by working with the supplier...

Aligned with our mission to alleviate pain, restore health, and extend life, we are seeking a dedicated Quality Engineer I to join our Ponce manufacturing business unit. This role offers an incredible opportunity to contribute to technical excellence in manufacturing quality operations while ensuring the delivery of medical devices that meet the highest standards of safety and quality for our patients and customers. 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...

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...

We are seeking an individual with a strong track record of work behaviors and extensive experience to join our team at Johnson & Johnson as a Data Steward, Quality Systems! This position can be located in Raritan, NJ, Titusville, NJ or Horsham, PA . This is a unique opportunity to contribute significantly to the development and implementation of world-class quality systems in the pharmaceutical industry. As a global leader in healthcare, Johnson & Johnson offers a dynamic and ambitious work environment where you can excel and demonstrate your capabilities. For more than 130 years, diversity, equity & inclusion (DEI) has...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer to be based 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...

Job Summary Auris Health, a member of Johnson & Johnson's Family of Companies, is recruiting for Head of Quality and Compliance (Q&C) Leader for our Monarch platform. This role will directly report to Global VP of Q&C Robotics and Digital Surgery and will be in Santa Clara, California. This role is an end-to-end role with responsibilities including Design & Development, Manufacturing/Operations, Quality & Compliance and Post Market Surveillance. As a leader, you will drive exceptional Quality and Compliance including focus on customer safety and product design, and manufacturability and reliability throughout the Product Development, Operations, Distribution, and Commercial processes. The...

The Opportunity Abbott’s Digital Solutions organization, part of the Medical Devices group, partners with our Diabetes, Cardiovascular, and Neuromodulation businesses to develop and commercialize digital technologies that expand access to care, optimize medical procedures, and improve chronic disease management. Together with Abbott’s life-changing medical devices, Digital Solutions leverages technologies such as AI and data interoperability to enable people to live life to the fullest. We are seeking a Director, Quality Assurance to join our team and establish the QA function within Digital Solutions for a diverse and growing portfolio of digital health products, including software as a medical device (SaMD),...

Onsite- 100% At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as a Supplier Quality Engineering (SQE) Manager , you will be responsible for ensuring the quality and compliance of electronic components, indirect materials, and services procured at our Medtronic Tempe Campus (MTC) for the design and manufacture of...

The Senior Auditor, Global Compliance Audit, has the primary responsibility of conducting global sales and marketing compliance audits for all of Abbott’s global operating divisions and Affiliates. Compliance audits provide assurance on the effectiveness of the key elements of Abbott’s Ethics & Compliance Program. The audit scope areas covered include, but are not limited to, the following activities undertaken by the Commercial businesses within the Corporation Meals, Travel and Entertainment Expenses Professional Service Arrangements Training & Education Support Charitable Contributions Commercial Transactions Research Funding and Scientific Activities /Publications No-Charge Products Promotional Practices Ethics & Compliance Program Third-party Activities Transparency Reporting...

The Opportunity The Director, Software Quality is responsible for Abbott’s corporate quality policies and strategic programs associated with both product and non-product related software inclusive of design and development, validation and cybersecurity. Products include PC application software, mobile applications, embedded firmware and hardware products for medical monitoring systems, all digital and cloud products across Abbott’s portfolio. This role leads and directs activities associated with quality, regulatory, and compliance areas of Abbott. Responsible for developing a standard interpretation of regulations for Abbott, facilitating policy development and deployment to the divisions. Actively influence regulations through industry groups and other channels. Provide oversight...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. As a Senior Quality Compliance Manager, the individual will play a crucial role within Abbott’s Heart Failure organization with primary focus to maintain overall Quality Management System compliance to internal policies, applicable standards and external regulatory requirements. What You’ll Work On The incumbent defines and develops strategy for external and internal audits (Regulatory Agencies, Corporate, Notified Bodies, Certifications...

Job Title Quality Manager Our location in Sylmar, CA currently has an opportunity for a Quality Manager . This is a fully onsite role . The Quality Manager is responsible for implementing and maintaining an effective Quality System. 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. WHAT YOU’LL DO Responsible for implementing and maintaining an effective Quality System as it relates to Post Market and Management Responsibility Independently lead groups and projects to resolve complex issues. analyze complex problems...

GeneDx (Nasdaq WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com . Summary The Quality Systems Specialist II is responsible for supporting, maintaining, and improving the Quality Management System (QMS) at GeneDx. This role...

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. Will monitor and approve cleanings for the manufacturing rooms and equipment...

Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting the patient first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs. Your dedication to quality is important to our customers and, most importantly, to their patients. We are seeking an Automation Quality Assurance Engineer who will be a team leader in the Quality Optimization team for system related quality processes responsible for ensuring the quality and integrity of software and hardware processes related to process automation. The ideal candidate will focus on...

We are searching for the best talent for a Regulatory Law Paralegal to be based in Titusville, NJ. Purpose The Regulatory Law Paralegal contributes to the achievement of key Johnson & Johnson Law Department priorities by providing proactive and professional support to the Regulatory Legal team and its business partners. You will be responsible for Work closely with regulatory lawyers and business partners to assist in the support and review of commercial and compliance programs and materials, which could include review of advertising and promotional materials and activities, social media, and regulatory compliance. Assist with advertising and/or regulatory challenges, develop...

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. Company Overview At Lilly, we serve an extraordinary purpose. We make...

Quality Assurance Senior Manager What you will do Let’s do this! Let’s change the world! In the rapidly evolving landscape of clinical trials, ensuring the quality and compliance of innovative technologies is paramount. This role reports to the Executive Director, Precision Medicine/Diagnostics and R&D Supplier Quality, and is dedicated to supporting the implementation of a comprehensive and proactive Quality Assurance (QA) strategy for diagnostic or health technology products used in Clinical Trials, including third-party collaborations and oversight. The individual in this role is crucial in managing and overseeing programs and projects related to R&D supplier/service provider quality, diagnostics, imaging, digital...

We value what makes you unique. Together, we can change healthcare worldwide. We are seeking a Senior Quality Engineer to join our team in Billerica, MA. This role is integral to ensuring the highest standards of quality and compliance in our medical device manufacturing processes. As a key member of our Quality team, you will collaborate cross-functionally to enhance product reliability, optimize processes, and uphold regulatory compliance. 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...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You will lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Medtronic’s eDiscovery program is a key program in the broader strategy of Global Information Lifecycle Management, Discovery Management, and overall good data stewardship. This position offers the opportunity to manage eDiscovery for a wide variety of litigation and legal matters. The eDiscovery Specialist reports to the Sr Program Manager of Global Information and Discovery Management. This is an individual contributor role. This role...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable for management of all assigned programs/products as the internal expert on US and international Codes, guidance, and industry standards pertaining to prescription medicine promotion. How you will contribute As our Associate Director, Global Regulatory Affairs...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Director, Process Optimization Lead (Unified Regulatory Platform) to be located in Raritan, NJ or Cambridge, MA. Purpose The Director, Process Optimization Lead (Unified Regulatory Platform) is responsible for driving an...

AbbVie’s Global Internal Audit function plays a critical role in protecting and enhancing the organization’s value through risk-based assurance and advisory services to internal stakeholders, senior management, and our Audit Committee of the Board. Internal Audit strives to be a critical function to evaluate company, industry and emerging risks, effectively partnering with the business, and consistently recruit and develop key talent. Our goals are carried-out through the talent of the audit team, while leveraging analytical and audit tools, supported by a dynamic and collaborative team culture. The scope of compliance audits may include, but is not limited to, the following...

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. The Senior Manager, Quality Engineer is responsible for quality oversight of engineering and validation lifecycle activities, including facility, equipment, and utility...

About the Role This position will drive computer system validation activities for the Summit site Manufacturing Execution Systems (MES) supporting the Summit, NJ Cell Therapy manufacturing site. This role is ideal for someone with a strong IT/Computer Science foundation and 5 years or more of hands-on experience in the pharma/biotech industry. You’ll partner with other cross-functional teams such as QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions and support. Key Responsibilities Lead end-to-end validation activities including test preparation, authoring of IQ/System/UAT scripts, Dry Run, test data setup, environment readiness, test execution facilitation,...

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. The Associate II, Shop Floor Quality Assurance team is responsible for 24x7 Quality collaboration and oversight of site operations, including but...

We are searching for the best talent for a Manager, Health Care Compliance to be based out of the Orthopedics' offices (e.g. West Chester, PA; Raynham, MA; Raritan, NJ; New Brunswick, NJ; Warsaw, IN; or Palm Beach Gardens, FL.) 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 Under the direction of the HCCO Orthopedics, the HCC Manager is primarily responsible for the implementation and support of programs designed to ensure the...

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

Sr. Supplier Quality Engineer Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our location in Temecula, CA , currently has an opportunity for a Senior Quality Engineer . This role will serve as liaison between internal Abbott third party manufacturers and Abbott Vascular. Ensures effective implementation of quality and compliance requirements between multiple quality systems and sites. THIS IS AN ON-SITE DAILY ROLE. WHAT YOU'LL DO Position Responsibilities Work...

Specialist Quality Assurance The primary function of the Quality Specialist is to assist in maintaining the quality system. The role can have responsibility for one or more of the following processes Batch release Complaint Coordination Metric maintenance Surveillance Program Testing Program Document Control Exception Report and CAPA System Batch and Sample Retention and Maintenance This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday. What You’ll Work On Assist with administration and ensuring compliance to Quality Management...

Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. Our expanding portfolio delivers measurable clinical and economic value – and opens doors. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare. Responsibilities may include the following and other duties may be assigned. Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory...

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 the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and...

About the role As a Supervisor, Quality Control, you will have a staff performing many biological, chemical, or physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods and may include environmental monitoring programs. You may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations. You will be responsible for results regarding product quality and conformance to regulations and quality policies. In some instances, you will be responsible for a functional area and may not have team members. This position works 600pm- 230am Monday-Friday....

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,...

Manager, Design Transfer Quality Engineering This position will have responsibility for the design transfer of all Diabetes Care Blood Glucose Monitoring Systems (strips, meters & accessories), FreeStyle Libre portfolio of products, medical device combination products, new medical sensors, Lingo which will deliver products to over 15MM customers globally over the next 5 years with a revenue of over $10Bn. In addition, this position will also be accountable of transfer of all designs (new product introductions, product changes to on market products, test method validations, complaint investigation techniques) into all manufacturing sites, including contract manufacturers. This position will be based...

We anticipate the application window for this opening will close on - 14 Oct 2025 Position Sr. Quality Engineer for Covidien, LP (a Medtronic company) located in Fridley, MN. Responsible for New Product Development (NPD) Systems Engineering, quality assurance, and regulatory compliance within the medical device industry. Ensure the development and maintenance of high-quality, reliable, and safe medical devices that meet or exceed regulatory standards and customer expectations. Coordinate complaint investigations for Medtronic’s returned implantable devices. Accept and handle returned implantable devices, cleaning and sterilization process. Coordinate test results, clinical data, DHR (Device History Records) and product performance data....

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Senior Manager, Global Regulatory Project Management and Strategic Planning within our Global Regulatory Affairs organization, based remotely. Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs)...

Your skills could be critical in helping our teams accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other product and disease-related materials for assigned products. As the product expert, this individual helps to develop and implement regulatory strategies related to promotional and advertising campaigns for marketed products and development projects. Provides input into labeling strategies for investigational and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB). We are an innovative global healthcare company with one...

Johnson & Johnson is recruiting for a Senior Director, BWI Quality & Compliance to support our Cardiac Electrophysiology business. The role is based in Irvine, CA. POSITION SUMMARY Head of Quality, responsible for ensuring effective implementation of BWI Quality Management System. RESPONSIBILITIES In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position Leads BWI Worldwide Quality functions, setting the strategies and goals in accordance with applicable regulatory requirements. Johnson and Johnson Enterprise, Medical Device and CSS policies and goals. Product Quality – Oversees directly and indirectly organization of Quality professionals,...

Careers that Change Lives Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. Agility and responsiveness are critical to our success with remote monitoring, wearables, robotics, AR/VR, telemedicine, and more. Experience what it’s like to work at a company with an exciting product pipeline of patented inventions driving innovation in the healthcare space. The Ear, Nose, and Throat Operating Unit is a global leader and trusted partner for innovative ENT solutions that improve patient access, outcomes, and customer satisfaction. We partner with the ENT community to understand the needs of customers and...

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. Associate Director - Import Trade Compliance Responsibility Statement Lead the operations...

Position Manager, Quality Assurance Technical Operations - Investigations Location Devens, MA Key Responsibilities Provides quality support to Devens Site through quality review and approval of investigations. Reviews and approves discrepancy reporting, investigations and corrections and actions associated with all areas of the manufacturing process including, incoming, manufacturing, facility, and utility systems. Provides quality support and oversight for Manufacturing Science and Technology and Validation protocols and reports. Provide guidance and decision making on deviation decisions within the manufacturing site and support areas. Perform routine GMP walkthroughs of processing and support areas within the Devens site....

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. What You Will Achieve In this role, you will Perform batch record review and final batch disposition for clinical and commercial materials to ensure high quality products are released in a timely manner Effectively review/approve GMP documents to ensure quality attributes are met. Participate in...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. We are seeking an experienced, high caliber Senior Supplier Development Quality Engineer to be responsible to act as the site interface to suppliers. What You’ll Work On Drives the development, maintenance and improvement of quality of components sourced from outside suppliers. Reviews new design specifications and proposes changes to existing specifications to support component quality and manufacturability. Develops...

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our Diabetes division currently has an opportunity for a Software Data Validation Engineer II. What You'll Do Investigate and report unexpected events, issues or software bugs through the data output from production telemetry. Investigation may include marco quality issues spanning multiple months of data...

Sr. Cleaning Validation Engineer Job Responsibilities · Serve as the Cleaning Validation lead of cross functional team and able to provide guidance during planning, designing and development of projects. · Write and review technical documentation (cleaning cycle development reports, SOPs, system lifecycle documentation, protocols & reports for engineering and validation testing, cleaning validation master plans) · Creation, execution of Cleaning Validation Protocols, including identification and resolution of non-conformances/deviations. · Assist in preparation of regulatory submissions and presents validation in respective SME areas to regulatory authorities during regulatory inspections. · Manage contractors performing system qualifications, ensure the quality of completed deliverables....

Quality Engineer II (2nd Shift) 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...

As System Owner responsible for overall delivery inclusive of technical direction, adherence to SLC deliverables, in the development and support of applications and systems by assisting in the preparation of system specifications, testing, and implementation of efficient, cost-effective solutions with different tech stack and architectures spanning N-Tier Architectures and, SaaS space inclusive of Salesforce. Responsibilities Work with PMs for management of projects, budget accountability and project deliverables. Post completion audit of projects and assist in continuous improvement efforts. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Serve as technical lead for projects/programs and technical teams to develop,...

Director of AI Model Evaluation & Quality Validation - LLMs & Generative AI This Opportunity We are seeking a highly skilled and experienced Machine Learning Expert to join our team and evaluate the effectiveness of our AI models utilizing Large Language Models (LLMs). The ideal candidate will have a strong background in machine learning, natural language processing (NLP), and a proven track record of working with LLMs. You will be responsible for assessing the performance, accuracy, and efficiency of our AI models, identifying areas for improvement, and providing actionable insights to enhance their effectiveness. You will work...

· Strategic Leadership & Vision Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and regulatory expectations. Champion regulatory innovation and novel approaches to accelerate development and approval timelines. Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination products and devices. · Global Regulatory Excellence Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure regulatory conformance and consistency across markets, maintaining compliance with evolving health authority requirements and internal governance. · Enterprise Collaboration & Influence Cultivate strong, collaborative relationships across Gilead’s global...

About This Role As a Sr. Associate II, Quality Assurance (Quality Systems), you will play a pivotal role in ensuring the compliance and efficiency of quality systems at our Biogen RTP facility. Your expertise will be vital in overseeing Quality Control compliance of exceptions and CAPAs, contributing to the issuance and management of GMP documents, and supporting internal operations. This role is integral to maintaining GMP standards and will involve collaborating across functions to drive continuous improvement and global alignment. You'll be responsible for authoring key site reports and facilitating critical meetings and governance boards. Your contributions will support regulatory...

The Senior Manager Regulatory Affairs will work for our Global Regulatory Services division within Leveraged Services. As a Senior Manager, the individual is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. This new team member will support key digital health technology activities (i.e., software, cybersecurity, telehealth, digital solutions, etc.) and be recognized as an expert and resource within the division. The individual should have a strong understanding of the software lifecycle management and software development, including design, validation, and maintenance in the device regulatory environment. Demonstrates...

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

The Associate Director Regulatory Affairs will work for our Global Regulatory Services division within Leveraged Services. As an Associate Director, the individual is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. This new team member will support key digital health technology activities (i.e., software, cybersecurity, telehealth, digital solutions, etc.) and be recognized as an expert and resource within the division. The individual should have a strong understanding of the software lifecycle management and software development, including design, validation, and maintenance in the device regulatory environment. Demonstrates...

Supplier Development Quality Engineer II This position works out of our St. Paul, MN location in the Structural Heart division. 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 Supplier Development Quality Engineer II , you’ll have the chance to develop components and associated quality requirements for new product initiatives. This position is responsible for managing supplier relationships, qualifying components and developing incoming controls that will drive the quality of future components. This will include technical support...

Objective / Purpose Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities...

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. Lilly’s Purpose At Lilly, we unite caring with discovery to make...

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

The Associate Regulatory Affairs Director (RAD) , Regulatory Science & Execution will be accountable for the develop ment, implement ation and maintenance of regulatory strategies for assigned project(s)/ product (s) and regulatory jurisdiction ( s ) , with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will provide tactical and strategic input to and leadership across regulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure effective communication and constructive working...

This position works out of our Atlanta, GA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The inspector provides an independent, unbiased evaluation of materials or the work of others. The results of the Inspector's evaluation are documented and communicated to organizational stakeholders with an interest in the evaluation's outcome - typically, this is supplier development and/ or manufacturing. The Inspector's approval certifies the work, or material meets the division's quality system requirements. Will...

This position works out of our Sylmar CA or Austin TX facilities. What You’ll Work On Abbott is currently seeking an experienced professional to provide Support for developing, updating and maintaining basic and routine elements of Abbott’s compliance program at the franchise, business unit, divisional or corporate level. Assists with the revision and administration of OEC education and training (including supporting materials) and assists with the implementation and administration of division monitoring plan. Core Job Responsibilities The Senior Analyst performs the following with moderate supervision from the OEC Manager/Director Supports and communicates with the business to provide OEC and divisional...

This Cybersecurity Compliance Manager position can work remotely within the U.S . We are seeking a leader to develop and manage a centralized, standardized framework for medical device cybersecurity compliance. This role will drive alignment across people, processes, and technologies to support Abbott divisions and product teams in mitigating medical device risks. The successful candidate will establish and lead a cybersecurity compliance program, oversee a team of specialists, and ensure adherence to relevant laws, regulations, and industry standards through audits, risk management, and expert guidance. What You’ll Work On Provide strategic leadership in developing and executing a product information security...

Associate Director, Portfolio & Program Management (PPM) The Associate Director in Regulatory Planning and Publishing works closely with various stakeholders to drive the identification, planning, execution, and management of activities that deliver high quality and timely regulatory and safety submissions for approval. The incumbent will be responsible for translation of regulatory strategy into an execution plan and is expected to have excellent project management skills with a strong track record of demonstrated leadership on cross-functional regulatory teams. Should be capable of independent management of all submission projects and documents, at any level of complexity, across all submission types throughout the...

About This Role As a visible member of the RTP Pharma Site Leadership team as well as the Global Quality Control Leadership team, you will provide both strategic and operational leadership for the Pharma Site Quality Control (QC) Operations organization. In this pivotal role, you will oversee a team dedicated to ensuring the highest standards of quality through chemical, biochemical, and biological analysis (microbiology) of various stages of drug substance and drug product material manufactured in our Parenteral Filling , Oral Solid Dose (OSD) , and Antisense Oligonucleotide operations at RTP Pharma. You will develop and manage QC budget plans...

This is a full time, on site position with M-F business hours About This Role A Sr. Associate I, Quality Assurance is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral facility. Specifically, this role will have primary quality oversight of the following activities (1) Batch Records, (2) Exceptions/Investigations and (3) QA Controlled Documentation What You ’ll Do Batch Record Review/Product Disposition Review documents (e.g., production records, test methods, raw data, and certificates of analysis) for compliance and determines acceptability for use in GMP production...