Quality & Regulatory Jobs in Pharma & Biotech

Regulatory Planner - VIE Contract Location United States of America, Swiftwater Target start date 01/12/2026 iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28. PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship. PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure...

DePuy Synthes is recruiting for position, located in MA Raynham , FL Palm Beach Gardens, ,IN Warsaw , NJ Raritan . Alternate Hybrid locations may be considered at Leeds ,UK or Loughbeg, Ringaskiddy; 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 on the specific country(s) that align with your preferred location(s) MA Raynham Requisition Number R-094617 St. Anthony's Road, Leeds, UK - Requisition Number R-095611 Loughbeg, Ringaskiddy -...

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with...

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with...

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with...

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with...

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...

The Head of External Manufacturing Quality – Large Molecule leads our Manufacturing Division's global External Manufacturing Quality organization for biologics and vaccines. This leader directs a multinational team of approximately 100 professionals and establishes the quality strategy, governance, and oversight model for products manufactured, tested, packaged, released, stored, and distributed through our company's external manufacturing network. The role ensures compliance with our company's requirements, applicable regulatory expectations, and global GMP standards while enabling reliable supply, supporting timely product launches, and strengthening the execution of technology transfers across approximately 30 external manufacturing sites spanning cell banking, drug substance, and drug product...

Job Summary The QMS Global Quality Compliance Director reports into the Associate Vice President, Global QMS and is a senior quality governance and compliance role responsible for driving strategy, execution, and oversight of key quality compliance activities across the Operating Units (OpUs) and associated sites. This role sits on the QMS Leadership team and provides leadership for global quality governance forums, including GPO, GVO, and GBO Quality Councils. This role serves as a critical connector between site quality teams, OpU leadership, QMS Topic Leads, and global quality governance bodies and Divisional Quality Council (DQC). The Global Quality Compliance Director is...

As part of the Global Clinical Supplies (GCS) Organization, the Sr. Specialist, Master Data Quality Management is responsible for driving data quality, governance, stewardship, and operational excellence across critical master data domains supporting Global Clinical Supply Operations (GCSO). This role helps ensure that master data is accurate, complete, compliant, and fit-for-purpose to support planning, manufacturing, packaging, distribution, regulatory compliance, and business decision-making. The individual partners with Data Owners, Process Stewards, IT, Business Operations, and Analytics teams to establish data quality controls, monitor performance through dashboards and Key Performance Indicators (KPIs), facilitate remediation, and support continuous improvement initiatives. The role is...

Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply....

Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply....

We anticipate the application window for this opening will close on - 31 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Medtronic is seeking a highly skilled...

We anticipate the application window for this opening will close on - 29 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Medtronic Mindset challenges us to act...

We anticipate the application window for this opening will close on - 28 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic Neuroscience , we bring innovation,...

We anticipate the application window for this opening will close on - 5 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Across our global Neuroscience organization, we advance...

We anticipate the application window for this opening will close on - 9 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we bring bold ideas forward...

We anticipate the application window for this opening will close on - 8 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life A career at Medtronic is like no...

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. What You’ll Work On Preparation of regulatory submissions for Electrophysiology devices to achieve departmental and organizational objectives. Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities. Acts as...

This position works out of our Madison, WI location in the Cancer Diagnostic Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often...

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

Our location in Temecula, CA, currently has an onsite opportunity for a 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 Provide Process/Quality Engineering support on the manufacturing line, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. What You’ll Work On Support project planning and perform assessments and mitigations...

Schedule- 8am-430pm. MAJOR DUTIES AND RESPONSIBILITIES 1. Initiates, documents, and supports deviation records and supplemental reports to investigate atypical events within the Engineering organization, including leading investigations and deviation supplementals as required. 2. Acknowledge and conducts investigations and deviations supplementals for facilities, utilities and/or maintenance deviations and supplementals. Accountable for Corrective Actions and Preventive Actions (CAPA) or actions related to regulatory observations, internal audits or deviations within the engineering department. 3. Supports readiness of the facility for regulatory inspection. Represents the maintenance department during regulatory agency inspections such as FDA / EMEA and/or during internal company audits. 4. Support maintenance...

The role will be based in either Gaithersburg MD, Santa Monica CA or The Netherlands. The Senior QA Auditor positions establish a continuum at the senior lever for carrying out more challenging audits. These positions are responsible for audits of AstraZeneca Cell Therapy manufacturing sites, contractors, suppliers, due diligence and other audits where a higher level of skills and experience is required. Audits are conducted in accordance with local and international regulations/guidelines and company quality standards to assure compliance with cGMP`s. The incumbents possess advanced audit skills and specialised knowledge in one or more different areas e.g. sterile manufacture, API´s,...

Do you have experience transforming digital processes with AI and automation, supported by knowledge of Regulatory Affairs strategy or policy? If you want to work on innovative projects of high importance for our Respiratory and Immunology (R&I) portfolio, then AstraZeneca is the place for you. Our aspiration is to be pioneers in science, leading in our disease areas to truly transform patient outcomes. This means our people are here to win, and we give you a breadth of opportunities to be curious and do cutting edge, unique work that has significant impact on science, medicines, and patients. The Global Regulatory...

Johnson & Johnson is currently recruiting for a Manager Supplier Quality! This position will be located in Athens, GA 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 This role ensures business, quality and compliance goals adhere to Johnson and Johnson (J&J) policies, enterprise standards and government-issued...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer to be based in Horsham, PA. Purpose The Senior Manager, Health Care Compliance Officer serves as a strategic healthcare compliance partner to Johnson & Johnson Innovative Medicine teams, enabling compliant growth through risk-based, principles-driven guidance and decision support. This role operates within a dynamic and highly regulated environment, translating evolving legal, regulatory, and policy requirements into clear, practical, and actionable guidance that supports both business objectives and ethical standards. Consistent with the Innovative Medicine compliance strategy, this position helps advance the evolution from a rules-based...

The Polio, Pertussis and Haemophilus influenzae type b (Hib) or PPH franchise is dedicated to safeguarding health through vaccines that protect against Polio, Pertussis, Tetanus, Hib, Diphtheria, and Hepatitis B. The RA PPH team is responsible for developing and executing strategic regulatory initiatives that maintain market leadership, support continuous product improvements, and ensure sustained compliance with evolving global regulations. The team serves as the critical interface between R&D, manufacturing, and Health Authorities to navigate regulatory requirements, manage lifecycle strategies, and drive market access for the PPH vaccine portfolio This position requires agility to work transversally across the PPH Franchise and...

Quality Manager This position works out of our Westfield, IN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. The Quality Manager is accountable for the Quality Operations Organization and leads a team of Quality supervisors/technicians/inspectors/specialists to support Manufacturing, Supplier Development, New Product Development, Distribution/Warehouse Value Added Services, and Quality Systems. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements. What You'll Work On Implements a staffing plan by...

The function of a Director, Regulatory Affairs is to combine scientific, regulatory, and business expertise to ensure that products developed, manufactured, or distributed comply with applicable regulatory requirements. Additionally, the Director may develop and supervise regulatory professionals. This role has division-level influence and is generally recognized as a key opinion leader and expert resource, both within Abbott and externally. The Director may influence evolving regulations and guidance, interface with regulatory agencies and trade associations, and provide executive management with regulatory metrics, insights, and strategic recommendations. WHAT YOU’LL WORK ON Responsible for compliance with applicable Corporate and Divisional policies and procedures....

We anticipate the application window for this opening will close on - 31 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Senior Regulatory Affairs Specialist, Radio Frequency,...

We anticipate the application window for this opening will close on - 2 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Quality Engineer II will support...

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Sr. Quality Engineer supports quality assurance activities within a regulated manufacturing environment, ensuring products and processes meet applicable quality, regulatory,...

We anticipate the application window for this opening will close on - 2 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Join a world-class medical device manufacturing...

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Education Bachelor’s degree in engineering required. millions of people worldwide. The Sr. Quality Engineer supports quality assurance activities within a regulated manufacturing...

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Senior Quality Engineer provides quality engineering leadership for machining and selected secondary operations, including anodizing and final pack. This role...

DePuy Synthes is recruiting for a Sr. Source Regulatory Compliance Specialist, located in Palm Beach Gardens FL, Raynham MA, Warsaw, IN or West Chester PA. Job Overview The Manager, Technology Regulatory Compliance, is responsible for leading compliance activities related to technical and regulatory requirements across the organization in support of product and non-products systems. This role ensures that technical processes, documentation, and system implementations align with applicable regulatory standards, quality system requirements, and internal policies. The position plays a critical role in managing compliance risk, conducting audits and assessments, supporting audit inspection readiness, and enabling compliant execution of technical initiatives...

Johnson & Johnson is recruiting for a Regulatory Affairs Specialist II , MedTech Neurovascular. 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 . Job Summary The Regulatory Affairs Specialist II position offers...

Johnson & Johnson Healthcare Systems, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting a Trade Compliance Operation Analyst! This position will be located in New Brunswick, New Jersey, with considerations given to alternate New Jersey J&J locations at the discretion of the business. Johnson & Johnson Health Care

Johnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, Quality Asset Management within Advanced Therapies to be located in Titusville, NJ; Raritan, NJ; Malvern, PA or Spring House, PA. 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 on the specific country(s) that align with your preferred location(s) Belgium - Requisition Number R-095461 Switzerland – Requisition Number R-095456 Remember,...

Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies. You will manage the commercial regulatory strategy and execution of such for multiple high-volume and/or otherwise complex brands...

Our Research and Development division Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle, including post approval marketing, to ensure high-quality, safe, and effective products, contributing to the company mission of improving and saving lives around the world. Our Research Quality (RQ) encompasses several functional quality groups who focus on technology and systems, suppliers, and internal processes. The functions perform both proactive quality oversight activities and auditing and provide support to strategic initiatives across our Research and Development division. The Good Laboratory Practice (GLP) team provides independent quality...

The Associate Director, Compliance & Ethics Investigations will be responsible for conducting professional, prompt and thorough investigations that will range from routine to complex in nature. The Associate Director will plan, conduct, and manage internal Compliance & Ethics investigations related to reported violations of company policy or law. Investigations may relate to, for example, sales & marketing practices, HCP interactions, conflicts of interest, fraud, and falsification of company documents. Investigators also support broader Compliance & Ethics objectives such as training, policy development, data analytics, and remediation. The successful candidate will work both independently and collaboratively across cross-functional teams including the...

The Director, Compliance & Ethics Investigations will be responsible for conducting professional, prompt and thorough domestic and international investigations. The Director, C&E will plan, conduct, and manage internal Compliance & Ethics investigations related to reported violations of company policy and law. The subject matters of investigations are broad and may include, for example, sales & marketing practices, HCP interactions, conflicts of interest, fraud, and falsification of company documents. This person will also conduct analysis and derive insights regarding investigation trends, provide insights to support remedial efforts, and serve as a key partner to other elements of the compliance function. The...

About This Role As an Associate II, Quality Control, you will serve as a key member of the Quality Control Raw Materials/Sample Control team at the Biogen RTP Pharma site. In this role, you will be responsible for sampling and inspecting raw materials, as well as managing manufacturing, retain, and stability samples. You will ensure the proper handling, documentation, storage, distribution, and disposal of materials and samples in compliance with GMP requirements. Additionally, you will support laboratory operations through LIMS management, sample logistics, investigations, and other operational support activities. Working both independently and collaboratively, you will play an important role...

Quality Compliance Senior Manager What you will do Serve as a GCP Subject Matter Expert, providing independent and objective quality advice in support of clinical trial activities and in line with current best practice. Provide quality oversight for Amgen programs for all stages of products in clinical development. Plan, conduct and report out on risk-based GCP audits (investigator site audits, affiliate audits, service provider audits, and study level audits) or support outsourced audits. Manage/support regulatory inspections and provide guidance and feedback on responses to health authorities, including root cause and CAPA plans. Provide quality oversight for the Risk Assessment...

Role Overview - Rockville, Maryland The Specialist, QC Analytical, performs routine and non-routine analytical testing to support cGMP lot release and stability of cell therapy products. The role executes approved methods (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell-based assays) with high quality and data integrity, maintains accurate documentation, and participates in laboratory investigations. The QC Specialist collaborates within the QC team and with cross-functional partners to meet testing timelines and ensure compliant operations. This position is for a 4 days per week, 10 hour s per day shift , Sunday through Wednesday . Role Responsibilities Analytical...

Specialist , Quality Control Analytical , Cell Therapy Wednesday - Saturday (4x 10 hour day shift) Role Overview The Specialist, QC Analytical, performs routine and non-routine analytical testing to support cGMP lot release and stability of cell therapy products. The role executes approved methods (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell-based assays) with high quality and data integrity, maintains accurate documentation, and participates in laboratory investigations. The QC Specialist collaborates within the QC team and with cross-functional partners to meet testing timelines and ensure compliant operations. This position is for a 4 days per week, 10...

POSITION SUMMARY Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. Our mission is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy. As QA Manager, Scientific Operations, you will own quality management across the team, spanning the Sample Management and Sample Operations functions. Working in close partnership with the Natera QA team, you will be responsible...

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered...

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

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

USE YOUR POWER FOR PURPOSE Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action. WHAT YOU WILL ACHIEVE Working with Pfizer’s dynamic maintenance/engineering team, you will play a critical part in managing the maintenance and reliability engineering activities involving the redesign, maintenance, and repair of utilities systems, buildings, and production/non-production...

We anticipate the application window for this opening will close on - 28 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Principal Regulatory Affairs Specialist develops and...

We anticipate the application window for this opening will close on - 31 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Are you a people leader who thrives...

We anticipate the application window for this opening will close on - 8 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we bring bold ideas forward...

We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden...

Join Abbott’s Corporate Audit team as a Senior Auditor, Global Compliance Audit where you will gain knowledge ’s four global businesses while learning valuable soft skills interacting with senior leadership. Corporate Audit is a rotational program, where after 2 to 3 years, the position leads to potential global career opportunities in finance, compliance, legal or sales/marketing roles supporting corporate or a division. Corporate Audit’s objective is to evaluate and improve effectiveness of risk management, internal control, and governance processes, and develop a pool of managerial talent for the company. This position may be located in the following Abbott locations Willis...

Position Responsibilities We are seeking a Growth and Improvement-minded Data Services Specialist in Quality Control that can help drive our Strategic Operating Priorities. Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business) Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is...

Johnson and Johnson Innovative Medicine, is recruiting for a Senior Quality Lead! This position will be located in Malvern, PA, with considerations given to Spring House, PA. 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 On this team, we provide end to end quality oversight of GMP...

The Operations Quality Senior Systems Engineer will investigate, identify, and implement state-of-the-art technology platforms, focusing on Quality Management Systems (QMS), Learning Management Systems (LMS), Document Management Systems (DMS), Artwork Management Systems, and advanced Data & Analytics solutions leveraging AI. This role acts as a senior technical leader to integrate technical advances into business solutions that drive productivity, compliance, and operational excellence across Quality and Operations. Responsibilities Lead the design, operation, and optimization of large-scale cloud services (AWS) supporting QMS, LMS, DMS, artwork, and data analytics platforms. Troubleshoot complex system issues and tune performance for enterprise-scale applications. Architect and develop robust,...

Purpose The Strategic Medical Writing Operations Team is dedicated to delivering high-quality, scientifically accurate, and strategically aligned clinical and regulatory documentation that supports AbbVie's mission to transform the standard of care. Our team serves as a critical link between research, development, and regulatory submissions, ensuring clarity and compliance in all clinical and regulatory documents. We strive to innovate and enhance the processes of medical writing through cross-functional collaboration, agile methodologies, and the integration of cutting-edge technology, driving forward AbbVie's commitment to improving patient outcomes worldwide. Responsibilities Defines scope of quality control activities with the document author and the required source...

This role serves to provide leadership at the site Quality Operations level to support strategic initiatives, product filings, continuous improvement, and management of the site Quality System. Quality excellence is a key strategic driver to ensure regulatory standards are understood and adhered to at the site operations level. This position holder will have responsibility for oversight of the Compliance and Regulatory activities for the site and ensure successful inspection outcomes and delivery of high quality, compliant products for the patients that we serve. Responsibilities Oversight of Compliance and Regulatory activities at the site operations level, specifically leadership of a team...

Technical expert that will independently identify, engineer, and optimize new data, software, or technology solutions that address critical business needs. Focus areas will include Laboratory Information Management Systems (LIMS), Automated Lab Testing utilizing software orchestration solutions, and advanced Data and Analytics solutions leveraging AI. This role acts as a technical leader to integrate technical advances into business solutions that drive productivity, compliance, and operational excellence across Quality and Operations. Responsibilities Lead the design, operation, and optimization of cloud services supporting LIMS, Automated Lab Testing solution (e.g. Scitara, Ignition, LabX), and data analytics platforms. Troubleshoot complex system issues and tune performance...

Technical expert that will independently identify, engineer, and optimize new data, software, or technology solutions that address critical business needs. Focus areas will include Laboratory Information Management Systems (LIMS), Automated Lab Testing utilizing software orchestration solutions, and advanced Data and Analytics solutions leveraging AI. This role acts as a technical leader to integrate technical advances into business solutions that drive productivity, compliance, and operational excellence across Quality and Operations. Responsibilities Lead the design, operation, and optimization of cloud services supporting LIMS, Automated Lab Testing solution (e.g. Scitara, Ignition, LabX), and data analytics platforms. Troubleshoot complex system issues and tune performance...

The Associate Director, International Regulatory Affairs Advertising & Promotion safeguards products and practices to adhere to the highest quality and regulatory standards. The Associate Director will be responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds. The Associate Director will interface with International Marketing, International Medical Affairs, Global Legal and Office of Ethics and Compliance with regard to advertising and promotion strategies and tactics intended for use globally. Responsibilities...

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...

Manager, First Shift Quality Control At Join our team and contribute to our mission of making a difference in global health. What You'll Be Doing You'll provide guidance and supervision to hourly Microbiology technicians, ensuring all testing and support activities are completed efficiently. Motivate, train, and resolve problems for your team while maintaining a compliant and safe environment. Administer personnel policies in accordance with the local bargaining agreement. Manage critical testing and/or assaying of validation, raw material, process intermediates, and finished product samples. Supervise hourly employees in their testing duties, including scheduling work assignments based on priorities. Promote teamwork...

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products. The Quality Control Manager provides quality oversight of the qualified utilities and facility environmental monitoring sampling at the West Point vaccine manufacturing site. The Manager, with guidance from the Associate Director of Environmental Monitoring, ensures the qualified utilities (Water-for-Injection, Clean Steam, Compressed Gases) and Facility EM (Surface, Air,...

Senior Director, Quality Are you ready to pioneer a modern Quality mindset that safeguards patients while accelerating delivery? As Senior Director, Quality for our Mount Vernon site, you will lead the end-to-end Quality function that releases every batch, from raw materials to finished product, ensuring cGMP compliance and reliable, quality supply to patients. In this high-impact role, you will set the vision and standards for a functionally independent Quality unit, steer regulatory and compliance strategy, and partner closely with manufacturing and supply leaders to deliver safe, effective medicines with confidence. You will coach and empower a large, multi-disciplinary Quality team,...

We anticipate the application window for this opening will close on - 18 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Senior Design Quality Engineer, supporting Released...

Job Title Associate Design Quality Engineer We currently have an opening for an Associate Design Quality Engineer for the Vascular division. This role is located at our Temecula, CA location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. MAIN RESPONSIBILITIES Product development core team member responsible for quality engineering deliverables including specification development, risk management, process and test method characterization and control plan development. Plans and performs assignments of a wide degree of difficulty. Analyzes, develops, and recommends quality engineering approaches required to meet design and production...

This position works out of our Tbilisi, Georgia location in the Established Pharmaceuticals business. As the Administrative and regulatory affairs assistant, you’ll have the chance to provide assistance and support to the country manager and other members of the company by handling day to day administrative tasks and contributing to the department projects and regulatory affairs projects. What You’ll Do Provide administrative services for all members of the company. Sending correspondence Preparing orders Office support (stationery, paper, water, tea, coffee, milk, organization of equipment repair , refilling cartridges, organization of office cleaning , minor repairs) ...

The Professional Education Compliance Lead is based out of Austin, TX position within the Cardiac Rhythm Management Division. This is a fully onsite role. 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. The Professional Education Compliance Lead is responsible for overseeing all compliance aspects of professional education programs involving physician engagement and payment. This role ensures adherence to U.S. and global regulatory requirements and internal policies, and serves as a key partner to the Office of Ethics and Compliance, Legal, Finance,...

As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including generative AI technologies designed to help millions of patients in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Prior experience working with software development teams, diabetes management devices (e.g. insulin dosing algorithms), and artificial intelligence/machine learning technologies is preferred. This role will also be...

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

Sr. Associate Quality Assurance AML 14 What you will do In this vital role, you will be part of a department that provides 24/7 operational support through non-standard work schedules, including weekends and holidays. In this role you will ensure the integrity and compliance of materials and processes that support the delivery of high-quality, life-impacting products. Specific responsibilities include but are not limited to Responsible for providing on-site support to manufacturing areas and Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good...

Associate Quality Control What you will do In this vital role you will be responsible for activities including microbiology & analytical testing, sample and data management and equipment and instrumentation operation and maintenance in a highly dynamic, team environment. This role is expected to work a 10-hour shift Saturday - Tuesday, from 645AM-515PM. Responsibilities include Responsible for one or more of the following activities in Quality Control including analytical testing, characterization, sample and data management Perform sample collection and sample handling to support GMP operations Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory procedures...

Specialist Quality Assurance What you will do In this vital role you will provide quality assurance support to the PQ organization as a subject matter expert of quality systems and records. In this team-based role you will directly add to the success of the Product Quality team by collaborating within PQ and with diverse levels in functional areas including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality and Process development on projects, issue resolution and investigations. The QA Specialist will use technical abilities and knowledge of QMS processes, procedures, and regulations to lead and deliver...

The Staff New Product Development (NPD) Quality Engineer provides Quality Engineering leadership on new product development projects in the areas of Design Controls and Design Transfer to Manufacturing including, but not limited to Risk Management, Design Verification and Validation Strategies, and Design Transfer to Manufacturing. The Staff engineer operates at a high level of independence and has strong competency with problem solving and escalation pathways. This role is for our Joint Reconstruction organization supporting our Shoulder Reconstruction portfolio of products. DUTIES & RESPONSIBILITIES The Staff NPD quality engineer will be responsible for the following, but not limited to Serve as...

Johnson & Johnson MedTech is currently seeking a Sr Program Lead, Regulatory Affairs to join our team located in Irvine, CA. 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 JOB SUMMARY Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. DUTIES AND RESPONSIBILITIES Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and...

DePuy Synthes is recruiting for a Manager, Technical Regulatory Compliance, located in Raynham MA or Palm Beach Gardens FL or West Chester PA. Job Overview The Manager, Technical Regulatory Compliance is responsible for leading compliance activities related to technical, system, and process regulatory requirements. This role ensures that technical operations, systems, and documentation comply with applicable regulations, quality system standards, and internal policies. The position plays a critical role in managing compliance risk, supporting audit and inspection readiness, and enabling compliant execution of technical initiatives by partnering closely with Quality, Regulatory Affairs, Engineering, Manufacturing, and IT teams. Key Responsibilities Lead...

The Senior New Product Development (NPD) Quality Engineer provides Quality Engineering leadership on new product development projects in the areas of Design Controls and Design Transfer to Manufacturing including, but not limited to Risk Management, Design Verification and Validation Strategies, and Design Transfer to Manufacturing. This role is for our Mitek Sports Medicine organization supporting our soft tissue solution portfolio of products. DUTIES & RESPONSIBILITIES Independently provide directions and oversight of the new product development quality activities across assigned projects. Apply various tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions as...

About This Role As a QA Associate III, you will apply strong knowledge of cGMP requirements, Biogen Quality Systems, internal procedures and your primary quality discipline to support compliant manufacturing operations. You will review and approve documentation that supports batch and cell bank disposition, assess product acceptability for continued processing or distribution, and provide timely quality direction on the manufacturing floor. You will partner across Quality, Manufacturing and PO&T to identify and resolve quality and compliance concerns, support inspection readiness and advance new product introduction technology transfers and restart programs. You will also provide technical writing and investigation support, including...

Johnson & Johnson MedTech is currently seeking a Sr Program Lead, Regulatory Affairs to join our team located in Plymouth, MN. 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 JOB SUMMARY Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. DUTIES AND RESPONSIBILITIES Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and...

We anticipate the application window for this opening will close on - 29 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Across our global Neuroscience organization, we advance...

In GBS we dare to change the way we work—being brave, resilient, and focused on simplifying how we deliver value. Through our global scale and diverse services, we drive outcomes with innovation and expertise. This requires a team that sees no boundaries, collaborates across functions, challenges the norm, and feels empowered, motivated, and engaged. The Senior Director, Compliance and Legal Services will lead the global build-out and maturation of a cohesive service portfolio spanning Compliance, Privacy, Legal Operations, and eDiscovery within GBS. Reporting to the Head of GBS Operations & Enabling Functions Services, this role supports strategy build, is the...

Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and product supply. We need...

Our Quality Assurance group ensures our products are manufactured, processed, tested, packaged, stored and distributed in alignment with our incredibly high standards of quality and meet all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The Quality Line Oversight Program at West Point is an entry level 2 year program with 8 month rotations focused on providing hands-on experience in pharmaceutical quality assurance supporting our Company’s largest and most complex...

The Senior Associate, Regulatory Affairs Submission Management , manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as very knowledgeable in their discipline expert and in regulatory affairs submission management. Responsibilities Manages medium to high impact (with respect to internal visibility,...

The Manager, Regulatory Affairs Submission Management , manages high impact, complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. The Manager is recognized as a discipline expert and resource in regulatory affairs submission management. Responsibilities Independently manages high impact (with respect to internal visibility, risk, complexity and criticality)submission projects to ensure...

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered...

We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As the Senior Director, Quality Control (QC Head) at Gilead, you will be responsible for providing strategic leadership and end-to-end oversight of...

Director, Global Supplier Quality Management Program Position Impact The Director, Global Supplier Quality Management Program serves as the Global Process Owner (GPO) for Supplier Quality Management, providing enterprise leadership and subject matter expertise for the strategy, governance, processes, systems, quality documents, and metrics of the supplier quality program across the end-to-end supplier lifecycle. This role is accountable for building and advancing a globally harmonized, risk-based, and customer-focused supplier quality program in partnership with internal quality functions at Gilead sites that strengthens stakeholder partnerships, drives consistent and scalable ways of working, and enhances quality, compliance, supply continuity, and operational performance across...

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Key Responsibilities Lead analytical quality oversight for external QC testing laboratories, stability programs, analytical methods, and related GMP analytical operations, ensuring activities, investigations, documentation, and quality decisions are scientifically sound, risk-based, and compliant with applicable...

Clinical and Pre‑Clinical QA Compliance Manager DePuy Synthes is recruiting for a Clinical and Pre-Clinical QA Compliance Manager, to be located in one of the following locations Raynham MA or Palm Beach Gardens FL or West Chester PA. Job Overview For the DePuy Synthes organization, the Clinical and Pre-Clinical QA Compliance Manager main job responsibilities include conducting internal and external GCP Clinical Quality Assurance (QA) audits which include system, program and clinical site investigator sites as well as GLP Preclinical Quality Assurance Supplier Audits. Additionally, this role will include GCP projects relative to supporting compliance activities across clinical research...

ETHICON, Inc., a member of Johnson & Johnson's Family of Companies and located in Cornelia, Georgia, is recruiting current college students for their Engineering Co-op Program. This position is designed for current college students. The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars, energy devices and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy...

The Manager, Standards Compliance provides leadership for ensuring manufacturing operations remain aligned with applicable standards, regulations, and internal policies. This role oversees the monitoring and tracking of emerging regulations and standards, and changes impacting the business. The position has a direct impact on product quality, patient safety, audit readiness, and operational excellence and partners closely with Manufacturing, Quality, Engineering, and Regulatory teams. Key Responsibilities Design, development and implementation of the standards management process within the regulatory intelligence program. Own and facilitate the regulations and standards change management and assessment process. Monitor regulatory changes throughout the product lifecycle with specific focus...

We anticipate the application window for this opening will close on - 27 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Peripheral Vascular Health (PVH) Operating Unit...

We anticipate the application window for this opening will close on - 18 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Medtronic, a global leader in medical...

We anticipate the application window for this opening will close on - 5 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Neurovascular Operating Unit develops technologies used...

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

The schedule for this position is Sunday-Wednesday 8AM-6PM About This Role The Quality Control Associate II is responsible for supporting key functional, tactical, and operational aspects of the QC Microbiology group at the Biogen RTP Pharma facility. An Associate II should possess a fundamental understanding of the Biogen Quality Systems and apply it in their daily support functions. Adherence to all cGMP requirements, a basic understanding of FDA/EMA regulations, effective interactions/communication with Quality management, personal development, and support of investigations. What You’ll Do Collect routine environmental monitoring (EM) samples in a clean room environment, including weekly air, particulate and surface...

Are you ready to transform Regulatory Intelligence into actionable insights for product teams? Do you want to work on innovative projects of high importance for our Respiratory and Immunology portfolio? Join us at AstraZeneca, where we are investing in internal capabilities to discover and accelerate the delivery of next-generation respiratory and immunology modalities for patients. As part of the Respiratory & Immunology (R&I) Regulatory Affairs team, you will play a crucial role in bringing these transformative therapies from the lab to life. Summary of Role We have a terrific opportunity for you to join our team within R&I Regulatory Affairs...

At AstraZeneca Cell Therapy , we are building the capabilities required to deliver complex, personalized therapies through a highly coordinated, patient-centered, and globally scalable supply chain. In cell therapy, every movement matters. The reliable and compliant flow of patient materials, critical manufacturing inputs, intermediates, and finished product is essential to protecting product integrity, supporting manufacturing continuity, and helping therapies reach patients on time. The Senior Specialist, Cell Therapy Trade Compliance – Free Trade Zone Operations plays a critical role in that mission by leading Free Trade Zone (FTZ) operations at AstraZeneca’s cell therapy manufacturing sites . This role helps ensure...

The Quality Analytics Manager utilizes data analysis skills and tools to evaluate Vertex operations, processes, and systems and recommends strategic process improvements based on research findings. This role is a key contributor in driving data-centric decision making within the Quality organization. The role also advises and supports business partners in design and delivery of data models and data analysis that enhance Vertex delivery and oversight. Key Duties and Responsibilities Identifies, analyzes, and interprets trends and patterns in complex data sets and prepares ongoing reports and data visualizations to support decision-making Develops and implements data analyses, data collection systems and other...

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered...

Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and supply. We need the...

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....

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

The Senior Quality Systems Specialist – Data Integrity and Risk Management proactively contributes to risk identification, assessment, mitigation, governance, and reporting. Ensures communication and reporting efforts follow global and local requirements to produce value-added, actionable risk analytics and governance information. Oversees the local risk assessment periodic review program and ensures site adherence to periodic review schedules. Manages the local risk register and maintains active involvement in reporting out and up to the platform and risk management Community of Practice forums. Assists in the es and implementation of Risk Management Systems designed to identify, eliminate or reduce, and insure against potential...

We are searching for the best talent for a Leader, Inclusion Compliance & Risk Management located in New Brunswick, NJ or Tampa, FL. As the Leader, Inclusion Compliance & Risk Management, you will help develop how Johnson & Johnson approaches workforce compliance, disability and accessibility governance, human capital reporting, and workforce data management. You will work across functions to tackle complex business challenges, strengthen decision-making, and ensure we are prepared for evolving regulatory and partner expectations. This role sits at the intersection of compliance, analytics, operations, technology, and employee experience. Success requires curiosity, strong business judgment, and the ability to...

We anticipate the application window for this opening will close on - 29 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic Neuroscience, we bring innovation, expertise,...

The Senior Specialist, QA Investigations , is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Devens Cell Therapy Facility. The role provides Quality oversight and assurance of the quality of manufactured products, in compliance with all applicable regulations and BMS policies and guidelines. Responsibilities Review and approve investigations/ CAPAs / effectiveness checks associated with the manufacturing site including but not limited to materials, manufacturing, laboratory, facility, and computer systems. May author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the...

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. The Associate Director Promotional Regulatory Affairs will work with a with a cross-functional review team and provide regulatory guidance and risk assessment to help business teams develop and deliver initiatives that are intended to comply with applicable laws, rules and regulations governing the advertising and promotion of pharmaceutical products in the US. Lead review and adjudication of promotional materials as are required through the AstraZeneca Approval Process (AZAP). Represent AstraZeneca to regulatory authorities for assigned...

Are you ready to steer global CMC strategy for cell and gene therapies that redefine what’s possible for patients? This role positions you at the center of breakthrough programs, where your regulatory leadership translates pioneering science into high-quality submissions and decisive health authority interactions that accelerate access for people who need it most. Based in Santa Monica, CA or Gaithersburg, MD, you will shape end-to-end CMC regulatory pathways across development stages, partnering closely with technical, clinical, and quality leaders. How will you apply your expertise to anticipate risk, set clear direction, and drive rapid, global approvals for a growing pipeline?...

Are you ready to steer US promotional regulatory strategy in a way that accelerates responsible growth and earns patient and prescriber trust? This role translates science into clear, compliant communication across healthcare professionals, consumers, and payers—so that what we say is as strong as the medicines we deliver. As Director of Promotional Regulatory Affairs, you will set the regulatory guardrails that enable confident brand execution and speed. You will partner closely with Medical, Legal, Commercial, and Corporate Affairs to shape claims early, guide labeling implications, and ensure promotional materials meet the highest standards across all channels—from print and broadcast to...

QC for Manufacturing - Team B Associate Quality Control What you will do In this vital role you will be responsible for activities including microbiology & analytical testing, sample and data management, as well as equipment and instrumentation operation and maintenance in a highly dynamic, team environment. Perform sample collection and sample handling to support GMP operations and Environmental/Water monitoring within Manufacturing and Utility areas. Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory procedures. This includes bioburden, endotoxin, TOC, conductivity, and MMV testing along with additional daily microbiological testing. Use of testing and data...

Manager Quality Assurance – US Distribution Quality Our location in Columbus, OH currently has an opportunity for a Manager Quality Assurance - US Distribution Quality in our Nutrition Division. What You’ll Work On Oversee (6) Distribution Quality Assurance (QA) Direct Reports + (2) Indirect Reports Implement quality standards and manage ongoing compliance for US Distribution. Provide Quality Leadership to US Third-Party and Abbott-Managed Warehouses Site Qualification and Audit Management - Lead evaluation/startup of new third-party warehouses and approval of respective warehouse quality agreements Monitor Ongoing Compliance Elevations - Audit observations, transportation or distribution events, temperature excursions, applicable registrations,...

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...

Validation Engineer What you will do In this vital role is within the Product Lifecycle Management organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. The team is responsible for new product introductions (NPI), product re-introductions (PRI) to Amgen Rhode Island’s Manufacturing Facilities (AR5 and AR30) and managing the lifecycle of ARI’s product portfolio. The schedule for this position is Monday – Friday Admin Day Shift. Responsibilities Support validation strategy and execute validation activities for manufacturing equipment, support equipment, and utilities, including validation planning, protocol development and execution,...

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

Regulatory Affairs Sr Mgr Duties Formulate and present CMC regulatory strategies, ensuring alignment with corporate objectives, in conjunction with Technical Operations, R&D, Commercial and other internal stakeholders, as needed, across investigational and marketed products; Develop risk register for all major regulatory submissions outlining potential regulatory risks and proposals for mitigation strategies; Coordinate and collaborate on the preparation of CMC components of regulatory submissions; Provide guidance for and contribute actively to the development of CMC related documents for regulatory submissions, Health Authority Meetings Requests, and Briefing Books, ensuring that they meet current regulatory standards including guidance and expectations are high...

Associate Principal Scientist, Regulatory CMC Digital Innovation Rahway, NJ or West Point, PA Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the...

Quality Engineer I 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. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. The position will be rotational, with the first year starting in risk management and patient safety and then moving into operations quality. What You’ll Work On Identify, review, and implement effective process control systems to support the development, qualification, and on-going...

This position works out of our Lake Forest, IL location in the Core Lab Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Regulatory Affairs Specialist II is responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day-to-day activities for change control. Provides regulatory directions on team activities. Apply basic regulatory understanding to support product and teams. Prepares U.S. regulatory submissions...

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

This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Supplier Quality Enginee r II drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You’ll Work On Assess potential new suppliers for technical, quality and...

2nd shift Quality Engineer II This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the 2nd shift Quality Engineer II , you’ll support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a...

The Regulatory Affairs Specialist II (Medical Events) position supports the Infectious Disease business in Lake Forest, IL on site . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. What You’ll Work On In this role, if hired you will be responsible for the timely review, documentation, and submission of Medical Device Reports (MDRs), including international vigilance reports for the...

The Executive Director, Promotional Regulatory Affairs is a senior enterprise leader responsible for defining and advancing the regulatory strategy that enables business growth while maintaining the highest standards of compliance, ethics, and scientific integrity. The PRA team are strategic business partner s who helps AstraZeneca accelerate innovation, bring medicines to patients responsibly, and create sustainable competitive advantage through trusted, and impactful engagement across the healthcare ecosystem. Leading a team of promotional regulatory experts across multiple therapeutic areas and business units, this role serves as a strategic advisor to senior and executive leadership, shaping decisions that influence product launches, brand strategy,...

The Director, US Advertising and Promotional Compliance, will serve as the therapeutic area lead and the Regulatory Affairs (RA) representative for assigned products. They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness and public affairs communications. The Director will also engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional material. The Director will also act as the primary liaison with FDA on ad/promo regulatory issues concerning promotional materials. Accountabilities Reviewing...

The Associate Director, Advertising and Promotion Compliance, US will serve as the Regulatory Affairs (RA) representative for assigned products and therapeutic areas . They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness and public affairs communications. The Associate Director will also engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional materials. The Associate Director may also act as the primary liaison with FDA on ad/promo regulatory issues concerning promotional materials....

The Director, US Advertising and Promotional Compliance, will serve as the therapeutic area lead and the Regulatory Affairs (RA) representative for assigned products. They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness and public affairs communications. The Director will also engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional material. The Director will also act as the primary liaison with FDA on ad/promo regulatory issues concerning promotional materials. Accountabilities Reviewing...

Responsible for the analysis of company quality requirements and the establishment, implementation and control of quality assurance systems and procedures across multiple disciplines. Has extensive experience across a range of business areas. Will lead a team of quality professionals. Reports to the Senior Director, Quality Management. At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide . Working here means being entrepreneurial, thinking big and working together to make the impossible a reality . If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you a...

We are now recruiting a n Associate Director , R&I Clinical Regulatory Writing ( CReW ) . A s part of a clinical delivery or submission team, the Associate Director provide s strategic communications leadership to projects, establish es communication standards and best practice, and continuously advocate s for quality and efficiency. The Associate Director also a uthor s strategic clinical-regulatory documents and provid es critical review to achieve high-quality standards, utilizing best practices for document and accelerated submission delivery . What You will Do The Associate Director, CReW , is expected to Independently manage clinical regulatory writing activities across...

The Supplier Quality Senior Specialist is responsible for work which supports the GMP/GDP Vendor and Material Management programs at the Devens Biologics site. This includes vendor qualification and management, material qualification and management, change management and supplier related non-conformance reporting and resolution. Key Responsibilities Qualification and management of GMP/GDP vendors, including assessment of vendors, creation and revision of Quality agreements and maintenance of the Approved Vendor List. Lifecycle management of starting materials used for the manufacture of drug substance, including material qualification and requalification, reduced testing, and direct dispense. Assessment of supplier change notifications (SCN) and identification and completion of...

The Senior Engineer, IT Compliance and CSV, supports computerized system validation, IT compliance, and change/deviation management for regulated computerized systems across the Devens Campus, including the Cell Therapy Facility (CTF). This role executes System Life Cycle deliverables, serves as a CSV subject matter expert for computerized system changes, and supports the IT Deviation Management, Computer System Audit, Change Management, and Risk Management programs. The Senior Engineer works collaboratively with Quality, Validation, Manufacturing, Engineering, and enterprise teams, and interfaces with global compliance and validation initiatives, serving as a site delegate as needed. Duties/Responsibilities · Execute assigned computer system validation (CSV) and...

We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden...

Position We are seeking an experienced Senior Director, Regulatory Affairs, to lead our regulatory strategy 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 guide product development and market entry strategies while maintaining a steadfast commitment to regulatory integrity and transparency. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical...

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

We anticipate the application window for this opening will close on - 28 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life LOCATION O nsite at a US-based Medtronic...

The Pharmaceutical Analysis & Digital Technologies (PADT) Analytical Capabilities & Operations (ACO) department of our Research and Development Division is seeking applicants for a Metrology and Validation Specialist position available at the Rahway, New Jersey research facility. The Metrology and Validation Specialist will work as part of the integrated US Metrology and Validation team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The role oversees and supports the onboarding, qualification, validation, and routine maintenance of analytical equipment and instrumentation within a GMP environment. The key responsibilities of this role...

The Pharmaceutical Analysis & Digital Technologies (PADT) External Capabilities, Validation, and Compliance (ECVC) department of our company Research Laboratories Division is seeking applicants for a Validation Specialist position available at either the Rahway, New Jersey research facilities. The Analytical Instrument Validation Specialist will work as part of the integrated Validation and Compliance team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The Analytical Instrument Validation Specialist role oversees and/or supports the validation of novel computerized analytical instrumentation within the GMP environment for multiple sites (Pennsylvania, New Jersey, and Schachen,...

Job Title Quality Technician II Divisional Information 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. This position works out of our Avon, Indiana location in the Abbott’s Electrophysiology (EP) business. MAIN PURPOSE OF THE ROLE Provides independent evaluation of materials, components, and products per specific instructions, and work process within the quality system. Quality and production support resource to ensure compliance with policies and procedures within an atmosphere of error prevention and continual improvement. MAIN RESPONSIBILITIES...

The Senior Specialist, QA Investigations , is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Devens Cell Therapy Facility. The role provides Quality oversight and assurance of the quality of manufactured products, in compliance with all applicable regulations and BMS policies and guidelines. Responsibilities Review and approve investigations/ CAPAs / effectiveness checks associated with the manufacturing site including but not limited to materials, manufacturing, laboratory, facility, and computer systems. May author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the...

The Senior Manager, Quality Assurance Material Operations, Cell Therapy role is responsible for the development, implementation, execution, and sustainability of quality and material disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. This individual will lead a team responsible for oversight and performance of the incoming material visual inspection, disposition, and eSystem master data programs. The individual will ensure timely and accurate delivery of disposition requirements from stakeholder groups such as Quality Control and supply chain. This individual will ensure compliant release of incoming raw materials and consumables, maintenance,...

Do you want to shape the future of oncology medicines and influence regulatory decisions that impact patients globally? At AstraZeneca, we are driven by our commitment to advancing science and delivering life-changing medicines. As a Regulatory Affairs Director, you will play a pivotal role in defining and executing US regulatory strategies that accelerate innovation and bring transformative oncology therapies to patients worldwide. This is an opportunity to lead complex regulatory initiatives across development, submission, approval and lifecycle management activities while partnering with leading scientists, clinicians and commercial teams across a global matrix environment. Why AstraZeneca? At AstraZeneca, we follow the...

Position Overview We are currently accepting applications for the role of Quality System Engineer. The successful candidate will be tasked with developing, implementing, and maintaining quality management systems to ensure compliance with industry standards and regulatory requirements. This position will require collaboration with cross-functional teams to identify opportunities for improvement, c and promote continuous improvement initiatives throughout the organization. Key Responsibilities Design and oversee quality control processes and documentation to ensure accurate and consistent procedures are followed. Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards. Conduct internal and external audits, and support...

Position Overview We are currently accepting applications for the role of Quality System Engineer. The successful candidate will be tasked with developing, implementing, and maintaining quality management systems to ensure compliance with industry standards and regulatory requirements. This position will require collaboration with cross-functional teams to identify opportunities for improvement, and promote continuous improvement initiatives throughout the organization. Key Responsibilities Design and oversee quality control processes and documentation to ensure accurate and consistent procedures are followed. Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards. Conduct internal and external audits, and support the...

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. Organizational Overview Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. This highly dynamic team is seeking a motivated and entrepreneurial Associate Director, Regulatory Affairs Strategy,...

Johnson & Johnson MedTech is recruiting for a Service Quality Engineer, located in Cincinnati, OH. At Johnson & Johnson, we believe health is everything. The Service Quality Engineer plays a key role in supporting the quality and compliance of service and repair operations for J&J MedTech Surgery Energy products. This position partners closely with Service Engineering, Complaint Management, Service Solutions, and cross-functional teams to ensure service processes meet quality, regulatory, and customer requirements while driving continuous improvement initiatives. Key Responsibilities In accordance with all applicable federal, state, and local laws/regulations and Johnson & Johnson policies and procedures, this position...

We anticipate the application window for this opening will close on - 11 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Medtronic, a global leader in medical technology,...

Position Principal Compliance Engineer, ECQ Location Summit West, NJ Purpose and Scope of Position The Principal Compliance Engineer, Equipment Commissioning & Qualification (ECQ), supports the successful operation of facility, laboratory, and business functions at Summit, NJ. This role involves interaction with internal team members, peer-level customers, and external service providers. The Principal Compliance Engineer will lead a team of contract or full-time personnel responsible for performing periodic reviews of equipment, policies, and procedures to ensure they remain in a validated state. Responsibilities include performing gap analyses, and leading small and large-scale projects to achieve departmental objectives. Required Competencies Knowledge,...

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Supply Chain/Warehouse Operations. This position will oversee and partner with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shift NIGHT shift, 6 PM – 6 AM, Panama schedule (12-hour shift patterns with a 2-2-3 work cycle, including weekends and holidays) The Specialist, QA Shop Floor, is accountable to own quality decision making as it relates to unexpected events on the production floor, including deviation triage and determination,...

As a Senior Regulatory Affairs Director you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. R&D Oncology drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them. What you'll do As the Senior Regulatory Affairs Director you will be accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity. You will ensure that the strategy is designed to deliver rapid approval with advantageous labeling in keeping with...

This position works out of our Lake Mary, Florida office within Abbott's Heart Failure Division and Acelis Connected Health business. The Regulatory and Quality Specialist serves as a key member of the Regulatory and Quality team, supporting regulatory compliance activities, accreditation documentation, state licensing, and audit preparation across the organization. Approximately 70% of the role focuses on healthcare regulatory compliance and accreditation, while 30% supports internal quality initiatives and continuous improvement efforts. What You’ll Work On Regulatory (70%) Support Joint Commission accreditation oversight, survey readiness, documentation reviews, corrective actions, and performance improvement initiatives. Leads onsite activities, communications and strategic planning...

Job Title Director, Regulatory Affairs Strategy - Cell Therapy Available locations Gaithersburg, MD Boston, MA South San Francisco, CA Santa Monica, CA Introduction to role Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care for patients? In this Director role, you will shape the regulatory path for programs that span oncology, immune-mediated and rare diseases—translating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets. You will join a high-performing, cross-functional environment where regulatory insight is central to program decision-making. Partnering with senior leaders and...

We are seeking to hire a Senior Corporate Counsel (Global TechOps & Pharma Quality) in Global Legal Technical Operations & Facilities . In this role you will focus on global support of our global Pharma Manufacturing unit and its sites, including regulatory and transactional counseling on FDA/cGMP, manufacturing supply and development agreements, and other related matters. Great medicine can't change the world if it never leaves the lab. Our Pharma Technical Operations (PT) organization is the global backbone that transforms scientific discoveries into real-world therapies. Joining our Global Legal Technical Operations & Facilities team means stepping onto a highly collaborative,...

As the Sr. Specialist Quality Engineering (QE) you will be responsible for the oversight of the Quality Risk Management, CQV, CSV programs for the Cell Therapy operation of the Tarzana facility. This includes Quality Review and Approval for including Quality Risk Assessments, Technical Reports, Validation Planning, Change Controls, Validation Protocols, Reports, as well as leading the technical quality arm of the Quality department. You will ensure that operations are compliant with the cGMP standards established by AstraZeneca and relevant regulatory agencies. Responsibilities You will provide leadership, direction and mentoring to ensure that the QE organization is successful in meeting the...

One of the focus of this role is the delivery of the Veeva Quality Vault portfolio and operational sprint releases. The other focus will be developing and implementing AI solutions that support and automate Enterprise Quality processes. This includes partnering with BI&T AI, data enablement and Analytics, business and site teams on high-value use cases, to architect and drive the end-to-end lifecycle from proof of concept through deployment. This position is responsible for the technical delivery of assigned projects/sprints supporting Veeva Quality Vault collaborating with the Technology Owners for Veeva Validation Manager, Veeva Quality Docs, and Veeva Quality Management System(QMS)....

An engineering professional that works with project owners, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The main objective is to establish evaluation, testing and documentation for risk management, commissioning and validation applying product and regulatory requirements and risk management to result in robust, high quality products. This includes optimizing systems that support the work in and around this area of responsibility. Responsibilities...

The Quality Assurance Manager is responsible for providing quality assurance support for some or all of the following manufacturing processes pharmaceutical products, medical devices, cosmetics, combination products and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training, Quality Intelligence, Compendia management and CAPA. This position will also translate strategy into tactical objectives to deliver strategic plans and regulatory updates. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product...

An engineering professional that works with project owners, automation engineers, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified automated systems equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The primary objective is to design and execute robust evaluation, testing, and documentation strategies that support risk management, commissioning, and validation in alignment with product, regulatory, and quality requirements. The role also contributes to optimizing automated systems, process controls, and related technical workflows...

Position In partnership with the Director of Process Management for Clinical Research & Development, the Senior Clinical Quality Operations Manager (Sr. CQOM) is accountable for the execution of operational quality management and inspection readiness activities across Eikon's clinical development programs, to whom this role reports . The Sr. CQOM oversees clinical quality operations across assigned clinical programs, embedding quality-by-design principles, risk-based quality plans, and vendor oversight into Eikon's clinical trials. In partnership withClinical Quality Assurance (CQA), the CQOM drives disciplined execution of quality plans and operational standards, enabling study teams to beinspection ready. This includesensuring consistent execution of quality-by-design(QBD)principles...

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place...

As Device Quality Engineer - Device Risk Management and Surveillance Excellence within our Global Device and Packaging Unit (GDPU), you will lead critical global processes for patient safety and regulatory compliance. You are accountable for maintaining and continuously improving Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes, ensuring Medical Devices and Drug-Device Combination products comply with ISO 14971, MDR, and other relevant regulations throughout their lifecycle. You will deliver expert quality support for risk management and post-market surveillance activities across the development pipeline and post-launch lifecycle management. The role involves collaborating with cross-functional teams and external stakeholders to ensure...