Quality & Regulatory Jobs in Pharma & Biotech

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

The Senior IT Risk, Security, and Compliance Analyst is an individual contributor responsible for supporting the security, compliance, and risk posture of business applications within the R&D IR portfolio. The role partners cross-functionally with risk, security, compliance, and business and IT stakeholders to facilitate initiatives that reduce risk, strengthen control effectiveness, and enable successful delivery of related projects. Key outputs include maintaining accurate program data, monitoring performance against objectives, supporting risk reduction activities, and contributing to the identification, development, and implementation of system enhancements that improve security, compliance, and operational effectiveness across the portfolio. Responsibilities Ensure compliance with applicable corporate,...

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

Employer Johnson & Johnson Health Care

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...

The Senior Design Quality Engineer, New Product Development, will be responsible for providing quality engineering support and leadership for New Product Development. Responsibilities Launch and stabilize new product launches through concept, design, development, and steady-state processes. Drives the development of product requirements, verification strategies, and validation strategies. Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction. Proactively engage partners to drive consensus and resolve issues in a timely fashion. Provide statistical...

We anticipate the application window for this opening will close on - 21 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 LOCATION O nsite at a US-based Medtronic...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Bristol Myers Squibb is seeking an Associate Director, Regulatory Excellence, ICVN to lead business management activities within the GRS ICV...

As Deputy Director, Drug Substance (DS) Manufacturing Quality Systems at our Pearl River site, you'll lead and develop a broad Quality Systems organization — spanning Principal Investigators, Technical Writers, and Quality Systems Support Associates — responsible for the full lifecycle of manufacturing quality records deviation investigations, CAPAs, effectiveness checks, periodic reviews, and QMS document updates. You'll keep investigations on track, products moving, and patients supplied, all while driving a culture of continuous improvement and operational excellence. You'll be a key voice in audits and regulatory inspections, a coach to your team, and a connector across functions. If you thrive in...

Sanofi delivers 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Sanofi Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. By driving its own transformation, Global MSAT fulfills an important function...

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...

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...

Lead Specialist Quality Assurance As the Lead Specialist Quality Assurance, you will be responsible for conducting and completing quality-related activities for third party manufacturing (TPM) oversight and to support a TPM in maintaining compliance with Abbott, internal, and external requirements. This position will be located at our Austin, TX Flex facility. What You’ll Work On This position is responsible for providing quality oversight of a TPM and supporting quality compliance related activities. Specifically, Manage TPM oversight activities, including but not limited to scorecards, communications, SCARs, etc., Provide quality support and oversight of compliance readiness activities related to a TPM,...

Senior Validation Engineer Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help get the nutrients they need to live their healthiest life. Working at Abbott At Abbott, you can do work that matters, grow, 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...

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...

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 West Point Quality organization ensures our products are manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. The Associate Director, Inspections lead will be a core member of the West Point Quality Assurance Leadership Team and serves as a quality leader accountable for the quality oversight and management of the Quality team overseeing Regulatory Inspections and Health Authority reporting supporting the West Point Manufacturing and Quality Control laboratories. The position will be responsible to ensure site’s compliance with applicable regulations, industry standards and Quality Management Systems. The incumbent...

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...

The Associate Director Quality and Standards (Q&S) Steward, Value & Implementation (V&I) Operations, Quality & Standards (AD, Q&S), position resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research. The AD, Q&S, is a role within V&I Global Medical and Value Capabilities (V&I GMVC) that reports directly to the Director, Quality & Standards Lead. The AD, Q&S, is an integral member of the V&I Operations team serving as a subject-matter expert around Quality and Standards and is held accountable for assisting and driving execution of the V&I Operations vision. The AD, Q&S, participates...

The Regulatory Intelligence Lead monitors and analyzes global regulatory, scientific, and policy developments and translates external signals into actionable insights that support our company's portfolio, pipeline, and strategic priorities. The role conducts targeted research, precedent analyses, and competitor assessments; supports the Science & Regulatory Policy (SRP) team’s policy and advocacy activities; and leverages modern intelligence tools, including AI-enabled capabilities, to enhance horizon scanning, knowledge management, and decision-making across Regulatory Affairs. Key Responsibilities Horizon Scanning and External Monitoring Monitor global regulatory, scientific, and policy developments across key health authorities and organizations (e.g., FDA, EMA, MHRA, PMDA, Health Canada, ICH, WHO) for...

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. SUMMARY OF POSITION This position is responsible for supporting internal tasks and filings that ensure regulatory filings of animal...

The Associate Engineer will provide engineering, commissioning / qualification / validation (CQV), and quality engineering support for the Rahway FLEx (Formulation, Laboratory & Experimentation) center located in Rahway, NJ. The FLEx facility supports formulation, filling, and packaging of non-sterile Oral Solid Dosage (OSD) and Inhalation products for clinical, stability, development and critical program needs (process development, scale-up, launch/transfer, and process optimization). The role supports timely delivery of clinical supplies and development batches by maintaining equipment, facilities, utilities, and computer systems in accordance with cGMP, safety requirements, and Reliability Maintenance best practices. The position requires regular interaction with partner groups (Facilities...

Intern - CFO - IT (Security, Risk and Compliance) As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Collaborate closely with Risk and Compliance Managers to ensure the effective and efficient delivery of program activities across Governance, Risk, and Compliance (GRC) domains, including IT Risk Management, IT SOX Compliance, Security Governance, Responsible AI Process Governance, and...

Intern - PDM - Internal Quality Operational Excellence As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Dashboard & Data Analytics Support Assist in developing and maintaining Operational Excellence dashboards and reports using Microsoft Office and data visualization tools. Collect, clean, and analyze operational data from QA and QC processes. Support tracking of key performance indicators...

Intern - PDM - CMC Regulatory Affairs, Strategy and Operations As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Support definition and early design of a governed AI-enabled capability intended to simulate elements of health authority review of CMC regulatory submissions. Work with CMC Regulatory Affairs subject matter experts to understand how experienced regulatory reviewers assess...

Intern - Legal & Compliance - Corporate Responsibility (Corporate Giving) As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Review final impact and budget reports from Gilead and Gilead Foundation sponsorship and grant recipients. Identify storytelling and content opportunities amongst Gilead grant recipients and execute content creation. Assist with supporting sponsorship events and benefits Assist with...

Intern - Development - Patient Safety As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Participating in both internal and external educational initiatives and activities Attending and participating in interdepartmental team meetings Data Analytics Create reports/dashboards working directly with stakeholders within the PS organization (Systems, Therapeutic Areas, Strategic Operations) Collaborate with team members to collect and...

Intern - Legal & Compliance - Corporate Legal As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Support the Corporate Legal group within Gilead’s Legal Department. Work with in-house attorneys and compliance professionals to support and provide substantive legal and business recommendations to stakeholders. Conduct legal research and analysis. Draft memoranda and provide recommendations based on...

Intern - Development - Global Regulatory Policy & Intelligence, Regulatory Affairs As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Global Regulatory Policy & Intelligence (GRPI) team monitors emerging regulations, evaluates their impact, and supports Gilead’s engagement with health authorities and industry trade associations on consultations that shape future regulatory frameworks. The intern will analyze clinical trial modernization topics and synthesize evolving regulatory expectations for (1) how...

Intern - PDM - Global External Quality (Global Supplier Quality) As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Develop process maps and workflows for supplier master data creation, maintenance, governance, and lifecycle management. Document current-state processes, stakeholders, systems, and data flows across functions. Analyze supplier master data structures and identify potential gaps, redundancies, and inefficiencies....

Intern - Development - Regulatory Operations As a Gilead i ntern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Under the supervision of the Sr. Manager, Innovation, Content and eXecution (ICX, RA) – Innovation Group, the Intern - Development - Regulatory Affairs will work with various team members of the Innovation Development team to support global innovation projects for Regulatory Affairs and other Development Operations (e.g., Patient Safety, Quality) areas....

Intern - PDM - CMC Regulatory Affairs, Strategy and Operations As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Design and pilot an AI capability-building curriculum that enables regulatory professionals to use AI confidently, critically, and responsibly in their everyday work Develop practical exercises and examples that demonstrate how AI can support regulatory work while reinforcing...

Intern - Development - Regulatory Affairs As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Support submission innovation initiatives by researching, designing, and testing AI- and automation-enabled solutions that improve the efficiency, quality, and scalability of regulatory submission processes. Partner with business SMEs to evaluate process, identify, and create solutions using digital technologies such as Microsoft...

Intern - Legal & Compliance - Intellectual Property As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Support the Intellectual Property (IP) group within Gilead’s Legal Department. Work with in-house attorneys to support and provide substantive advice to the business. Conduct legal research, analysis, and investigations; draft memos and provide recommendations on specific legal issues relevant...

Intern - Legal & Compliance - Litigation & Investigations As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Support the Litigation & Investigations team within Gilead's Legal, Compliance, & Corporate Responsibility Department. Conduct legal research, analysis, and investigations; draft memos and provide recommendations on specific legal and litigation issues relevant to the business. Work with in-house...

Intern - PDM - Quality Control (Method Validation) A s a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance our company’s mission but will allow you to gain real world experience at one of the most innovative organizations in the world . You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs . Key Responsibilities will include, but are not limited to the following Independently support development and execute GMP method validation. Run experiments according to test methods, specifications,...

Intern - Legal & Compliance - Legal (GLBP) As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Gaining experience in various areas of the Global Legal Business Partners department, which will entail working with in-house attorneys to support and provide substantive advice to the business including but not limited to commercial, medical affairs, development, manufacturing, public...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities can provide you with great development and a chance to see if we are the right company for your long-term goals. Our company's Global Clinical Trial Operations (GCTO) team is currently recruiting for summer interns. GCTO is a global organization operating in over 50 countries and is responsible in the delivery of our company's diverse development portfolio. It is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are...

2027 Future Talent Program - Global Regulatory Affairs & Compliance US Subsidiary - Intern Drug Shortages & Support Functions (DSSF) The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals This intern position is part of the Global Regulatory Affairs and Clinical Safety (GRACS) US Subsidiary function within our Company's Research Laboratories. This is an exciting time to join the US Subsidiary...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research Labs Division can provide you with great development and a chance to see if we are the right company for your long-term goals. This assignment is in the Healthcare Quality improvement (HQI) team within Global Medical Proficiency and External Affairs (GMPEA). GMPEA serves as the Center of Excellence for HQI strategy, professional relations and external affairs, independent medical education (IME), and our Research and Development Division Grants worldwide. This function exists within the broader Value and...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research Lab Division can provide you with great development and a chance to see if we are the right company for your long-term goals. The Process & Quality Management Team within Global Data Management & Standards is looking for talented and motivated students for Summer internships. Selected individuals will support strategic and operational projects related to process and quality in clinical data management. Working alongside experienced members of the team, the successful candidate will assist with special...

The Future Talent Program features internships that lasts up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. The Global Regulatory Affairs and Clinical Safety Operations, Process, and Systems function supports and drives core business operations and capabilities across the Global Regulatory Affairs and Clinical Safety division. The team is keenly focused on innovative business approaches and leveraging state-of-the-art information management tools to enable effective and efficient execution of our...

2027 Future Talent Program - Country Clinical Quality Manager US Intern The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities can provide you with great development and a chance to see if our company is the right company for your long-term goals. Our company's Global Clinical Trial Operations (GCTO) team is currently recruiting for summer 2027 Interns. GCTO is a global organization operating in over 50 countries and is responsible in the delivery of our company's diverse development portfolio. It is critical that for all company-sponsored clinical trials...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development division can provide you with great development and a chance to see if we are the right company for your long-term goals. Regulatory Planning and Publishing (RPP) is responsible for driving innovative quality planning, achieving publishing and delivery excellence, and ensuring compliant regulatory submissions to facilitate successful review by health authorities worldwide. RPP drives innovation through collaboration, and a commitment to quality and compliance in alignment with our core values. The organization consists of...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. Join Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company. Salary range The salary range for this role is $39,108 through $111,111. FTP2027 RL2027 Required Skills Preferred Skills Current Employees apply HERE Current Contingent Workers apply...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. Within our Research Labs division, the Quality Assurance group is seeking two interns who will work collaboratively in a team environment to help advance Quality throughout the drug development life cycle. GDQ Internship Opportunity (2 positions) The role of Global Development Quality (GDQ) within our Research and Development Division QA...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Global Support Functions Division can provide you with great development and a chance to see if we are the right company for your long-term goals. The Global Safety & Environment Intern will provide environmental, health, and safety (EHS) compliance and technical support at the Millsboro, Delaware manufacturing facility related to environmental compliance programs (Air, Water, Waste). Required Education and Skills Currently pursuing a Bachelors/ Master’s Degree in Safety, Environmental Science, Engineering, Biotechnology, Chemistry, Biology or another technical...

The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. The co-op for the Regulatory Compliance & Partner Operations (RCPO) within the Global Regulatory Affairs Clinical Safety (GRACS) Operations, Process & Systems (O.P.S.) organization will support the RCPO team in designing and operationalizing business processes, tools, and governance for efficient and effective document records management. This role will provide exposure...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Global Support Functions Division can provide you with great development and a chance to see if we are the right company for your long-term goals. The Global Safety & Environment Intern - Environmental Compliance, Sustainability & Stewardship (ECSS) Team – will provide support to Company facilities globally related to environmental compliance and sustainability programs (air, water, waste, remediation, sustainability). Projects may include Assisting with environmental compliance program implementation and improvements. Supporting environmental activities at Company sites, including...

The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. We are seeking a highly motivated and technically skilled student majoring in the life sciences, medicine, pharmacology/pharmacy, or related discipline for a Co-op role. The goal of this position is for the individual to gain broad insight into the drug development process and knowledge of regulatory affairs. The student should...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Quality Inspector I. Purpose The Quality Inspector I will perform basic inspections and sorting of incoming materials, parts/components. Provide support as needed to the Operations group. You will be responsible for Perform inspections of purchased parts according to well-defined criteria using standard visual, physical, mechanical, and/or electrical measurements Ability to perform visual inspection on...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Quality Inspector I. Purpose The Quality Inspector I will perform basic inspections and sorting of incoming materials, parts/components. Provide support as needed to the Operations group. You will be responsible for Perform inspections of purchased parts according to well-defined criteria using standard visual, physical, mechanical, and/or electrical measurements Ability to perform visual inspection on...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Quality Inspector I. Purpose The Quality Inspector I will perform basic inspections and sorting of incoming materials, parts/components. Provide support as needed to the Operations group. You will be responsible for Perform inspections of purchased parts according to well-defined criteria using standard visual, physical, mechanical, and/or electrical measurements Ability to perform visual inspection on...

Support the planning and execution of the safety strategy for Oncology assets during the entire lifecycle of the drug and during due diligence activities. Main responsibilities Supports the Safety Leads and Product Safety Teams (PSTs) to translate nonclinical and clinical safety findings to facilitate benefit-risk decision making and risk mitigation for oncology products in clinical development as well as on the market. May lead development and implementation of an asset safety strategy with support of PST-L or management Leads the review and synthesis of scientific safety data for critical regulatory and clinical documents — including IB’s DSURs, PSURs, RMPs CSRs,...

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now...

We anticipate the application window for this opening will close on - 28 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 - 17 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 This role supports Quality Engineering activities at...

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,...

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 A Quality Engineer I supports product development, manufacturing, and lifecycle activities by ensuring compliance with quality systems and regulatory requirements. The...

We anticipate the application window for this opening will close on - 17 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 This role supports the Operations Quality function...

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...

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

Quality Program Manager - Packaging Supplier Quality Events This position works out of our Columbus, OH location in the Nutrition Division . The Quality Program Manager, supporting Packaging Supplier Quality Events is responsible for leading a team of Supplier Quality professionals focused on supplier event management, supplier performance, continuous improvement, and supplier quality system maturity. This role serves as a key liaison between suppliers, manufacturing sites, quality leadership, and cross-functional business partners to ensure timely resolution of supplier quality issues, drive preventive quality improvements, and strengthen supplier capabilities across Abbott's packaging supply base. This leader will foster a high-performance...

Are you a quality-focused leader who thrives in a fast-paced manufacturing environment? We are seeking an experienced Incoming Quality Assurance (IQA) Supervisor to lead a critical function that directly supports production, customer satisfaction, and regulatory compliance. In this role, you will oversee the day-to-day operations of the Incoming Quality Assurance department, ensuring incoming raw materials, components, and packaging meet the highest quality standards before entering production. This is an excellent opportunity for a hands-on leader who enjoys developing teams, improving processes, and driving operational excellence in a regulated environment. This position works out of our Casa Grande, Arizona location...

This is not a remote opportunity Must be able to travel up to10 % Our location in Princeton, NJ, currently has an opportunity for a Senior Customs & Trade Compliance Analyst. You will provide subject matter expertise and project leadership for site import/export matters, ensuring compliance with all relevant customs regulations and trade laws and regulations, including 19CFR,15CFR, FDA, USDA, and other US regulatory agency requirements. What You’ll Work On Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Act as subject matter expert regarding compliant import/export of goods and participate in and/or lead site/division projects related to...

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

JOB SUMMARY The Sr. Director, Quality Systems will lead the design, implementation, and continuous optimization of the Quality Management System (QMS) for the Heart Recovery platform and own strategy and capability development for the broader Quality & Compliance organization supporting the platform. This role ensures product quality, regulatory readiness, operational excellence, and a high-performing, scalable quality organization across development, manufacturing, and post-market activities for cardiac therapies and devices. This role is appointed the Management Representative and is responsible for ensuring that quality system requirements are effectively established and maintained. DUTIES & RESPONSIBILITIES In accordance with all applicable federal, state and...

Johnson & Johnson is seeking a Regulatory Compliance Manager based in Irvine, California . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Purpose The Regulatory Compliance Manager will strengthen quality and compliance practices across the organization. The position supports sound decision-making, effective processes, and sustained regulatory readiness. The Regulatory Compliance Manager leads the internal audit program and evaluates alignment with applicable regulations, international standards, and quality-system requirements. This position coordinates...

That's what makes us Roche. In Pharma Technical Development, we actively collaborate and develop creative technical solutions to efficiently transform scientific ideas into products that reliably deliver our pipeline to patients . As a Lab Analyst, you will join our Global Analytical Development and Quality Control team, a leader in developing and executing testing methods for our biologics pipeline . You will contribute to our mission through innovation, teamwork, and continuous improvement in a dynamic environment . The Opportunity You perform a broad variety of basic and complex physico-che mical tests for biologics and other pharmaceutical compounds according to GMP...

That’s what makes us Roche! The Opportunity The PDQ Quality Lead supports the Roche/Genentech Organization through the development and delivery of Quality strategies, audits and conclusions for entities (e.g. molecules in development, post approval products, affiliates, processes) based on a risk-based approach. Quality strategies are based on the Critical to Quality framework which encompass Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Personalised Healthcare (PHC) and Computer Systems (CS) requirements. The Quality Lead will generate Quality strategies, evidence and actionable data through the conduct of audits and other quality activities to assess the Quality status and be able to support...

We anticipate the application window for this opening will close on - 22 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 Sr. Principal Regulatory Strategy Specialist is...

We anticipate the application window for this opening will close on - 23 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...

It is critical that, for all our company sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The Country Clinical Quality Manager(CCQM) position has a significant impact in achieving those objectives. Under the guidance of the Country Clinical Quality Management Lead, the CCQM oversees all Clinical Quality Management (CQM) activities in the respective country/cluster. The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Process Quality Technician to be based in San Angelo, TX . Under the guidance of the Process Quality Leader, the Process Quality Technician (PQT) provides technical support to identify causes for non-conformances and process failures. Furthermore, the PQT implements corrections to maintain process performance and compliance with Ethicon's QSR, GMP, and ISO requirements. Key...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Process Quality Technician to be based in San Angelo, TX . Under the guidance of the Process Quality Leader, the Process Quality Technician (PQT) provides technical support to identify causes for non-conformances and process failures. Furthermore, the PQT implements corrections to maintain process performance and compliance with Ethicon's QSR, GMP, and ISO requirements. Key...

The Senior Quality Engineer – In Vitro Diagnostics is a senior subject matter expert responsible for ensuring the quality, safety, and regulatory compliance of IVD’s across the full product lifecycle—from early development through commercialization and lifecycle management. Partnering with the Senior IVD Director, this role requires deep technical and regulatory expertise including EU IVDR, FDA 21 CFR Part 809/812/820, ISO 13485, ISO 18113, and ISO 15189. The incumbent serves as a strategic quality partner to cross-functional teams including R&D, Regulatory Affairs, Manufacturing, Clinical, and Laboratory Operations, providing expert guidance on design controls, analytical validation, clinical performance evaluation, and post-market quality...

Use Your Power for Purpose At Pfizer, the impact you will have on improving patients' lives is profound. You will play a crucial role in navigating and interpreting the growing regulatory demands to ensure optimal patient care. Your expertise and commitment are crucial in adapting to these changes and maintaining the highest standards of patient care. Join us in our mission to make a global impact on patient care. What You Will Achieve Under the direction of the Senior Manager, Quality Records & Training Compliance, the Associate, Quality Records is responsible for ensuring the compliant execution of electronic workflows, records...

As the Senior Manager, Regulatory Affairs Advertising and Promotion within our GRA Advertising and Promo Team, you will be responsible for conducting the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns. Ready to get started? With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. As the product A&P expert, contribute to the development and implementation of...

The Quality Assurance Supervisor II is responsible for the organization, administration, and supervision of Quality Assurance employees within the manufacturing operations. Responsible for properly overseeing the day-to-day operations by prioritizing shop floor presence. This includes delivering high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, achieve desired financial performance including cost reductions, and build a culture of high performance for the team. Ensures that appropriate controls are developed and maintained for new, intermediate and finished products. Responsible for GMP compliance, manufacturing quality, product control and release, system execution and quality planning for the...

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

This position works out of our St. Paul/New Brighton location in MN in the SH division. Structural Heart Business Mission Why We Exist. 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. T his position is responsible for developing, establishing and maintaining quality systems programs, policies, processes, procedures, training materials, and controls enhancing the performance and quality of products and the divisional capability to demonstrate conformance to established standards and agency regulations. What You’ll Work On Provide expert level guidance and direction of the...

This position works out of our Santa Clara, CA location in the SH division. Structural Heart Business Mission Why We Exist. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in...

We anticipate the application window for this opening will close on - 15 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 Cardiac Rhythm Management group is a...

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 Careers that Change Lives This individual will...

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

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...

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...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Staff Source Compliance Specialist, located at either Guaynabo, PR; Cornelia, GA; Raritan, NJ or San Angelo, TX. Purpose The Staff Source Compliance Specialist, under the supervision of the Source Quality System Lead, is responsible for establishing and maintaining a robust compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures,...

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

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...

About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. The Director, GCP Quality Assurance is...

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 The Grand Rapids, Michigan manufacturing site produces...

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 At Medtronic Neuroscience, we bring innovation, expertise,...

Sr Quality Engineer This position works out of our Altavista, VA location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Altavista, Va. , is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you...

Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations NYC, NY Gaithersburg, MD Boston, MA South San Francisco, CA Santa Monica, CA Introduction to role Are you ready to set the global regulatory direction for first-in-class cell therapies and turn science into approved medicines? Do you see yourself steering complex programs to competitive labels and rapid, global patient access? This role leads the strategy for our most visible and complex cell therapy programs, translating breakthrough science into timely approvals and meaningful labels that unlock lifecycle value. You will work across discovery through commercialization, bringing clarity and pace to decision-making...

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?...

Key Responsibilities Serve as a Lead Quality Engineer for medical device combination product development programs , with a strong focus on design controls, risk management, and lifecycle quality oversight . Partner closely with Device Engineering on new combination product development, supporting design verification, design validation, and technology transfer activities. Ensure compliance with applicable regulatory requirements and standards , including FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971 , and Gilead Quality System requirements. Plan, implement, and track approved quality improvement initiatives , ensuring timely execution of action items and deliverables. Interface with internal cross‑functional teams,...

As an Associate Director, RSM, you will have a primary focus on regulatory portfolio planning across multiple programs and assigned submissions of increasing complexity. Portfolio planning and submission assignment include, but are not limited to, developing global filing plans, planning and executing original marketing applications across multiple regions, and partnering with the Global Regulatory Lead in aligning the regulatory strategy within the regulatory project teams. You will be responsible for partnering with RA Liaisons and GRAD (Global Regulatory Affiliates and Distributors) in regulatory submissions portfolio planning and oversee the submission execution of the full submission lifecycle as a functional area...

Johnson & Johnson is currently seeking a Director, Enterprise Regulatory Compliance, to join our Enterprise Regulatory Compliance Assessment team located in New Brunswick, NJ; Raritan, NJ; Titusville, NJ; Horsham, PA; Athens, GA; Cornelia, GA; or Washington, DC. 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) United Kingdom- Requisition Number R-097570 Remember, whether you apply to one or all of...

We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in New Brighton, MN. This new team member will be overseeing our innovating Transcatheter Aortic Valve Implantation Franchise within the Abbott Structural Heart Franchise. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development activities to ensure both investigation and commercial regulatory approvals are achieved. In this role, you will provide regulatory input on design and development activities to cross functional teams including software development. Additionally, provide submission authoring and compilation to meet program objectives and timelines. What You’ll Work On Represent Regulatory...

The Director, Regulatory Affairs provides leadership, direction and support for regulatory policy and cross-business regulatory initiatives within the company, actively influencing changing regulations and guidance affecting the company through participation on trade associations and interfaces with regulatory agencies. This person will direct activities associated with capturing domestic and international information both internal and external that impacts the quality, regulatory, and compliance areas of Abbott and keep management abreast of regulatory changes and the impact they could have on the organization. Also, this person will direct and manage cross-business regulatory activities designed to address emerging regulatory issues, incorporate strategic action, 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...

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

Job Directs the Jacksonville - FL, Johnson and Johnson Surgical Vision Quality Operations organization, ensuring compliance with quality requirements, continuous supply to customers, compliance and regulatory agencies requirements, among others. Responsible for taking a leadership role in defining short and long-term strategies for the Jacksonville facility. Has direct accountability through direct reports, over inspection and release of incoming raw materials, in-process and final Quality inspection and testing. Directs the Quality Engineering team and Quality Systems site execution. Engages and collaborates with Franchise Quality teams as well as cross functional Supply Chain functions including Operations, Makes Engineering, Production Planning and...

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

Johnson & Johnson is currently recruiting for a Quality Engineer! This position will be located in San Lorenzo, PR. Reports to Quality Operations Lead, Quality Operations Leader or designee and with the objective of maintaining high-quality standards for the product manufacturing process and the compliance with regulatory requirements, provides leadership, technical support and direction to Plant Operations and Quality Assurance during the design, development, enhancement, revision and implementation of the quality systems for the efficient manufacturing of products and processes. Provide support and expertise on problem solving, process improvements and in the usage of quality tools. Ensure compliance with...

Johnson & Johnson is currently recruiting for QA Validation Specialist II LVV! .This position will be located in Raritan, NJ. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.Janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies....

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

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

Regulatory Affairs Manager - Oncology and Regulatory Promotion What you will do In this vital role you will be responsible for formulating and communicating the regulatory promotional position for approved and/or pipeline Oncology products and disease state. Responsibilities Provide strategic direction for product and disease communications and associated activities by interpreting current regulatory environment to ensure truthful and non-misleading communication to health care community, patients, and the public Serve as a regulatory advertising and promotion lead for approved and/or pipeline Oncology product and disease state Ensuring deliverables are consistent with the product label, compliant with US FDA regulations and...

Life at BMS 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,...

We anticipate the application window for this opening will close on - 14 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 Customer Quality Regulatory Inquiry Manager will...

We anticipate the application window for this opening will close on - 17 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...

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to...

Purpose Primarily responsible for leading the management of GCP quality activities in support of studies and projects across one or more clinical programs to drive proactive quality management, and ensure compliance with corporate policies and functional procedures and applicable global regulations. As the primary GCP quality interface cross-functionally in R&D for the product, this individual will influence and provide oversight of activities that include execution of the Comprehensive Quality Strategy game plan, informal surveillance, assessments as appropriate, design and execution of a “fit for purpose” audit program with the goal of submission-ready quality data, first pass approvals by health authorities...

Sr Associate Compl iance Duties Partner with US Compliance Leads in implementing and overseeing Amgen’s Corporate Compliance programs and policies, ensuring alignment across therapeutic areas and business functions; Implement and drive understanding of Compliance and Business strategy within the business by providing actionable advice and aligning compliance initiatives with Amgen priorities; Serve as an adviser to staff and managers, offering guidance on the interpretation and implementation of Amgen policies and procedures; Ensure consistent adherence to applicable laws, regulatory standards, and internal procedures that impact Amgen’s compliance program; Design, develop and deliver training programs, educational materials, and workshops aligned with Amgen...

Head of Regulatory B ioanalysis Location Gaithersburg, Maryland, US Hybrid Working 3 days per week in the office Bold Disruptors. Push the boundaries of science. Fearlessly break new ground . Are you ready to w ork at the cutting-edge , where scientific innovations and an entrepreneurial spirit are the norm ? W e’re looking for dynamic thought leaders with curious minds, who are comfortable taking smart risks and constantly challenging the boundaries of science all the while learning and developing core skills and experiences. What we do We are a global, science-led BioPharmaceutical business and our innovative medicines are used...

Execute Compliance area activities related to compliance projects, inspections (external, internal, customers), and regulatory submission documentation. Responsibilities Responsible for conducting a comprehensive internal audit program and ensures that the Internal Audit system is effectively implemented. The incumbent must work closely with the QA Director in the handling of external regulatory inspections and on the resolution of regulatory compliance issues. Assists in the development, implementation and continuous improvement of the Internal Audit System and utilizes audits and consultations as a training vehicle to increase awareness of Compliance expectations. Monitors and maintains plant compliance with Operations and regulatory/applicable standards requirements. Participates in...

Support the planning and execution of the safety strategy for Oncology assets during the entire lifecycle of the drug and during due diligence activities. Main responsibilities Supports the Safety Leads and Product Safety Teams (PSTs) to translate nonclinical and clinical safety findings to facilitate benefit-risk decision making and risk mitigation for oncology products in clinical development as well as on the market. May lead development and implementation of an asset safety strategy with support of PST-L or management Leads the review and synthesis of scientific safety data for critical regulatory and clinical documents — including IB’s DSURs, PSURs, RMPs CSRs,...

Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors, and Executive Medical Directors. Leading Product Safety Teams (PST) and support one or more products as the PST Lead and ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products Lead and set the strategy for key pharmacovigilance documents, including but not limited...

Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors, and Executive Medical Directors. Leading Product Safety Teams (PST) and support one or more products as the PST Lead and ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products Lead and set the strategy for key pharmacovigilance documents, including but not limited...

The Quality Associate supports the Quality Function that they are responsible for within Operations. As a member of the Quality function, provides real-time shop floor oversight to the assigned operations. Partners with Site colleagues to create an environment of the highest performance standards for the operations. Drives continuous improvement in the Operations on site. Responsibilities Responsible for various aspects of quality assurance and quality control related to their functional area. Ensures that product within the plant is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements. Partners with Manufacturing SMEs and Shift Supervisors to drive...

Support the planning and execution of the safety strategy for Oncology assets during the entire lifecycle of the drug and during due diligence activities. Main responsibilities Supports the Safety Leads and Product Safety Teams (PSTs) to translate nonclinical and clinical safety findings to facilitate benefit-risk decision making and risk mitigation for oncology products in clinical development as well as on the market. May lead development and implementation of an asset safety strategy with support of PST-L or management Leads the review and synthesis of scientific safety data for critical regulatory and clinical documents — including IB’s DSURs, PSURs, RMPs CSRs,...

Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors, and Executive Medical Directors. Leading Product Safety Teams (PST) and support one or more products as the PST Lead and ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products Lead and set the strategy for key pharmacovigilance documents, including but not limited...

Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors, and Executive Medical Directors. Leading Product Safety Teams (PST) and support one or more products as the PST Lead and ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products Lead and set the strategy for key pharmacovigilance documents, including but not limited...

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

Senior Associate - Regulatory Affairs What you will do In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements. To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions To assist the Global Regulatory Lead to manage GRT interactions Key responsibilities include Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency...

We anticipate the application window for this opening will close on - 12 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 Cranial and Spinal Technologies (CST) Operating...

About This Role The Associate Director, Clinical Quality & Compliance (CQC), serves as a strategic quality leader within R&D Quality & Compliance (RDQC), providing oversight, guidance, and expertise to support the effectiveness of the Quality Management System (QMS) across Research, Development, and Medical (RD&M). This role is responsible for driving a culture of quality and compliance through leadership of Vendor Quality Governance activities, Functional Quality Representation (FQR) for clinical studies, quality risk management, investigations, CAPA oversight, inspection readiness, and continuous improvement initiatives. The Associate Director partners closely with cross-functional stakeholders to proactively identify quality risks, implement sustainable solutions, and ensure...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Position Principal Compliance Engineer, ECQ Location Summit West, NJ Purpose and Scope of Position The Principal Compliance Engineer, Equipment Commissioning...

SUMMARY The Head, Clinical Development & Operations (CD&O) Quality is the senior leader accountable for defining and leading the global GCP quality, compliance and integrity strategy across Clinical Development & Operations. Reporting to the Head of Clinical Development & Operations and serving as a member of the CD&O Leadership Team, this leader provides independent, authoritative advice on the quality and regulatory risks associated with Pfizer's global clinical-development portfolio, operating model, technology strategy, external partnerships and organizational transformation. The role holds enterprise accountability for the effectiveness and continued evolution of the GCP quality-management framework across clinical development, from first-in-human studies through...

Use Your Power for Purpose Our breakthroughs would not make it to the hands of patients without our dedicated and agile pharmaceutical manufacturing team. We rely on members who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have the medicines they need when they need them. The significance of your role cannot be overstated, as you help bridge the gap between innovation and patient care. By being part of this team, you contribute...

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...

Key Responsibilities Serve as a Lead Quality Engineer for medical device combination product development programs, with a strong focus on design controls, risk management, and lifecycle quality oversight . Partner closely with Device Engineering on new combination product development, supporting design verification, design validation, and technology transfer activities. Ensure compliance with applicable regulatory requirements and standards , including FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971 , and Gilead Quality System requirements. Plan, implement, and track approved quality improvement initiatives , ensuring timely execution of action items and deliverables. Interface...

Responsible for compliance with applicable Corporate and Divisional Policies and procedures. What You’ll Work On Review material, equipment, and systems quality through examination, inspection, measurement, or testing of raw materials, components, sub assembly, final assembly, packaging, labeling and documentation. Contributes to validation testing as defined on validation protocols with engineering guidance. Ensures that all evidence documentation complies with governing procedures. Audits and verifies processes such as line verification or environmental conformity to prevent quality system and manufacturing impact. Reviews and verifies compliance of documentation such as batch records, reports of nonconforming materials, inspection records. Notifies supervision of issues or errors,...

Job Title Quality Engineering Technician II Divisional Information Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. This position works out of our Westfield Indiana location in the Structural Heart Division. Hours are 230pm to 1100pm Mon - Fri, with occasional Saturday overtime. Main Purpose of Role Provides technical assistance to engineering to support manufacturing efforts by implementing corrective and preventative actions. Assists engineers in developing methods and procedures to control or improve manufacturing processes. What You’ll Work...

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. We are recruiting for a Regulatory Affairs Manager to join our team in Alameda, CA. In this role, you will combine knowledge of scientific, regulatory and business issues to enable...

Use Your Power for Purpose The Rochester Senior Validation Engineer is responsible for planning, scheduling, executing and leading various validation project assignments such as qualification, validation, and requalification activities related to manufacturing process, equipment, critical utility systems, product, cleaning, and/or sterilization processes. This role will also be responsible for the development/authoring of project plans, protocols, test scripts and reports throughout all life cycle of the process from initiation to continuous monitoring. The position will work closely with area owners and suppliers to finalize validation/qualification requirements for process, equipment and systems, ensuring that company policies, procedures, applicable regulations and guidelines are...

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. What You Will Achieve In this role, you will Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements. Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution. Conduct statistical analysis of testing results...

As a Co-op in the MD Quality and Compliance (Q&C) Digital Solutions organization, you will have the chance to Use state of the art tools and take advantage of training courses offered at J&J. Collaborate with teams internal and external to the advanced analytics to implement customer-centric solutions for data analytics and process improvements Perform software development and validation to support medical device quality system digital solutions. Learn and apply various software development and lifecycle management techniques. Promote digital culture and capabilities across J&J medical devices Strengthen communication and leadership skills. Work with a diverse team of data scientists, analytics...

As a Co-op in the MedTech (MT) Quality Systems and Digital Services organization, you will have the chance to Collaborate with teams across J&J MedTech on software projects and software governance. Support and/or perform validation activities for quality system solutions, including requirement development, validation planning, software testing, etc. Learn and apply various software development and lifecycle management techniques. Develop and contribute to training materials including procedures and knowledge articles. Promote digital culture and capabilities across J&J medical devices. Strengthen communication and leadership skills. Work with a diverse team of quality engineers, data scientists, app developers, etc. Take advantage of training...

As a Co-op in the MedTech (MT) Quality Engineering organization, you will have the chance to Collaborate with teams across J&J MedTech on Quality Engineering projects. Support and/or perform risk management activities. Learn and apply various statistical techniques to analyze data. Develop and contribute to training materials including procedures and work instructions. Strengthen presentation, communication, and leadership skills. Work with a diverse team of quality, development, test, and design engineers. Take advantage of training courses offered at J&J. Support project teams in ensuring the product being developed is safe and effective for patient use. The Quality Engineer Co-op will Have...

The Lead Digital Health Quality Engineer will serve as representative on cross-functional SaMD and Digital Health Software product development teams, driving design controls, DHF management, software validation, and risk management (ISO 14971) throughout the software life cycle. This role will Author, review, and approve QMS and project documentation — including risk management files — to ensure products are developed, tested, and released in compliance with applicable SDLC procedure and/or medical device regulations. This role will lead quality process improvement initiatives, support regulatory characterization and audit, and contribute to cybersecurity quality activities, applying IEC 62304 and strong technical writing and cross-functional...

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...

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 Careers That Change Lives As a Pre-Market...

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 Upholds Division approval requirements to supplier and monitors feedback per project timelines. Analyzes incoming material defects. Generates and maintains incoming inspection procedures. Trains inspectors to these procedures. Owner of Non-Conforming Material Reports (NCMRs) issued to supplier for nonconforming supplied material and works with the supplier on the investigation and root cause analysis. Generate test protocols,...

Senior Associate, United States Regulatory Professional – Obesity and Related Conditions What you will do Amgen is seeking a United States Regulatory Professional (USRP) supporting products in the Obesity and Related Conditions Therapeutic Area (TA). Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of Amgen molecules. In this product-facing role, you will support the creation and submission of regulatory documents under the supervision of a more experienced regulatory lead. The USRP provides operational support for U.S. regulatory execution by coordinating submission deliverables, maintaining compliant documentation, and partnering cross-functionally to...

Life at BMS 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,...

Senior 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 set the global regulatory vision for pioneering cell therapies and turn breakthrough science into real options for patients? This role leads high-impact programs across cancer, immune-mediated and rare diseases, guiding them from current stage through licensure with clear, competitive pathways to approval and labeling. You will shape strategy for complex, visible programs, bringing clarity, pace and rigor that accelerate access for patients. You will report to the Executive Director, Cell Therapy Regulatory...

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 anticipate the application window for this opening will close on - 12 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...

The Sarbanes Oxley (SOX) Risk Architect & Compliance Lead role is accountable for facilitation of IT risk management processes. Collaborates cross-functionally to help mature and execute the IT Risk Security and Compliance processes which include governance, risk assessment, risk analysis, risk metrics, risk reporting, supplier monitoring, internal / external audit support, and technology enablement. Provides leadership for the creation of a SOX Compliance Strategy, project execution and improvement initiatives for IT. Creates strategies and processes related to all areas of Governance, Risk Management and Compliance. May coordinates the efforts of several groups to ensure compliance with other federal and industry...

Director, Corporate Compliance The Director, Corporate Compliance will serve as a strategic compliance partner to key business functions across Natera, with particular focus on our rapidly growing Oncology business. Reporting to the Sr. Director of Corporate Compliance, this individual will provide practical, solutions-oriented compliance guidance to business leaders while helping the organization identify, assess, and proactively manage healthcare compliance risk. This role will partner closely with Oncology Sales, Marketing, Medical and other cross-functional stakeholders and will provide compliance guidance related to commercial activities, clinical trials, pharmaceutical partnerships, companion diagnostics, healthcare professional engagements, and other evolving business initiatives. The ideal...

We are seeking an Associate Director, Quality Control to lead the Beam Massachusetts Quality Control team in delivering compliant, scientifically sound, and timely GMP testing while maintaining a continuous state of laboratory and inspection readiness. This on-site role will provide site-based QC leadership for routine GMP testing operations supporting Beam’s clinical and late-stage programs, and will help support the team’s transition from a clinical-stage QC group to a late-stage, commercial QC operation. The successful candidate will be responsible for leading a team performing release, stability, method qualification/validation, and method transfer testing while ensuring that analytical methods, laboratory equipment, LIMS/LES builds,...

Are you a highly skilled professional, interested in Quality Excellence, driven by a passion for innovation and a desire to make a tangible impact? At Roche, our commitment to quality in Pharma Development is unwavering. We deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society. The Opportunity As Quality Excellence Lead in our Quality Excellence Infrastructure team, you will Shape the global ecosystem Drive, maintain, and continuously elevate our Quality Infrastructure strategies to deliver organizational efficiencies, scalability, and measurable productivity gains. Unlock data-driven decision-making Manage critical Quality data to maintain...

MAIN PURPOSE OF THE ROLE QA Compliance is responsible for maintaining and strengthening the Quality management system so that Abbott Laboratories meets the standard. The Compliance team manages the documentation system, systems for food safety and laboratory quality, internal and external audit programs, pest control and sanitation program and stakeholders for governmental law and legislation. The Compliance Coordinator develops and keeps all Quality management system. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our...

The Opportunity The Logistics & Distribution Quality Leader will lead and direct efforts as it relates to quality compliance and controls across international and domestic product movements, warehouse operations and materials management. They will be responsible for identifying, developing, implementing, and maintaining an all-encompassing quality compliance program that aligns with our enterprise QMS and ensures our facilities and processes are audit ready. They will be responsible for representing Supply Chain, Logistics, and Warehouse in all internal and external Quality Audits. What You’ll Work On Include, but are not limited to, the following Oversee the Change Control processes, coordinate activities across...

Incoming Quality Technician II / CMM Programmer The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health. Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics. Our location in Irving, TX, currently has an opportunity for Incoming Quality Technician II / CMM Programmer. Working under minimal supervision, the IQA Technician II performs...

The Opportunity The Sr. Warehouse Quality & Document Specialist will lead, support, and direct efforts as it relates to quality compliance and controls across international and domestic product movements, warehouse operations and materials management. They will be responsible for supporting the development, implementation, and maintenance of an all-encompassing quality compliance program that aligns with our enterprise QMS and ensures audit readiness at all Abott’s locations. They will support the optimization of Quality Operations across all warehouses, enterprise-wide. What You’ll Work On Include, but are not limited to, the following Oversee Quality Documentation, coordinate activities across departments, and monitor change controls...

The mission of Quality Assurance is to safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high-quality data and clinical supplies. Working in the Finished Goods Platform TPQM (Third Party Quality Management) department within our Research & Development Division. You will be responsible for serving as the quality representative for and providing quality oversight of contractors performing various GMP activities supporting the production of clinical supplies, on behalf of our Company Key responsibilities include Act as a Lead Quality Liaison...

The Quality Control Microbiology Manager is responsible for planning and prioritizing resource allocation in Upper Merion Biopharma quality control microbiology laboratory to meet testing requirements for product release, raw material, utility, in-process, etc. Oversee the operation of QC Microbiology area which includes bioburden, endotoxin, and other microbiology testing areas. Responsible for managing training of quality control analysts, transferring assays from the development group, qualifying, and validating new assays and implementing assays to be used for quality control purposes to support manufacturing and marketing of the product. Other functions conduct laboratory investigations related to product testing, compile reports in support of...

The Global Patient Safety Individual Case Safety Report (ICSR) Manager is responsible for performing Individual Case Safety Report (ICSR) processing activities, including case book-in, triage, case entry (structured field data-entry, event coding, narrative writing, and pursuit of follow-up information), finalization and reporting. The Global Patient Safety ICSR Manager works with a high degree of independence and is proficient at troubleshooting problems to create and execute improved internal procedures, and to ensure compliance with applicable regulatory requirements. This individual ensures that all work performed is in accordance with relevant regulatory guidelines. By virtue of their experience, the Global Patient Safety ICSR...

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 is seeking a Regulatory Affairs Specialist...

Job Title Quality Assurance Manager We are seeking a Quality Assurance Manager for Abbott Vascular in our Temecula, CA site. This is an onsite role. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. Job Summary This position provides leadership and guidance for the department, has responsibility for recruiting, developing and retaining talented employees, supports company goals and objectives, and communicates key information to staff members and senior management. What You’ll Work On Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written...

This hybrid role could be based at any of AbbVie's location in the US such as North Chicago, IL Cambridge, MA, Worcester, MA Irvine, CA, San Francisco, CA or Florham, NJ Purpose As an independent RDQA Organization, our commitment is to drive quality excellence as a strategic advantage across all stages of discovery and development for the lifecycle of the product to achieve product realization and to accelerate access to innovative therapies for our patients. AbbVie’s R&D global trial footprint has been expanding due to growth in the pipeline and the complexity of global development resulting in an overall increase...

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...

The Audit & Compliance Manager manages and coordinates audit, inspection, and compliance activities across Data, Technology & Engineering (DTE) and business functions. This role serves as the primary liaison between operational teams and auditors, ensuring timely preparation, execution, response, and remediation of Internal Audits, GxP audits, and regulatory inspections. The role partners closely with Internal Audit, Quality Assurance, SOX PMO, system owners, and business teams to ensure audit commitments are met and compliance obligations are fulfilled. General Responsibilities Serve as the primary DTE point of contact for IT-related audit, inspection, and compliance requests across GxP, Internal Audit, and operational audit...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Senior Director, Compliance Policy & Education is a member of the Compliance & Ethics Leadership Team responsible for three enterprise...

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,...

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 The Senior Supplier Quality Engineer for New...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Johnson & Johnson MedTech’s Robotics & Digital Surgery (RAD) business is seeking an accomplished Director Software Quality Engineering & Cybersecurity for the OTTAVA Robotic Platform to be located at Santa Clara, CA. The Director leads the quality engineering strategy and execution for software-enabled medical technologies across the OTTAVA robotic surgical platform. This leader oversees software quality engineering activities supporting software in medical...

J&J MedTech is recruiting for a Senior Quality Engineer located in Cincinnati, OH. The role of a Senior Quality Engineer at J&J MedTech is to apply the principles of engineering, mathematics, statistics, organizational excellence, and risk management to help the company achieve two major objectives in support of the J&J Credo Meet and exceed the expectations of our customers Achieve and maintain compliance with regulatory expectations The Senior Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products, and ensures compliance to good manufacturing practices, international...

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 Principal Professional Quality is responsible for the implementation and management of the Quality Assurance program for the Core Dx Digital Health Solution products. The role includes oversight of design and development quality processes, post-market support, and continuous improvement initiatives. The Principle...

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