Quality & Regulatory Jobs in Pharma & Biotech

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...

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics, IVD, and Clinical Research expertise to drive the strategy, design, analysis, and interpretation of clinical validation studies for kidney disease and other high-priority germline projects. PRIMARY RESPONSIBILITIES Strategic Study Design and Analysis Independently lead the design, analysis, and interpretation of clinical validation studies to support in vitro diagnostic approvals (e.g., CDx, 510(k), PMA, etc.) Regulatory Compliance Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as FDA. Drive statistical...

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics, IVD, and Clinical Research expertise to drive the strategy, design, analysis, and interpretation of clinical validation studies for kidney disease and other high-priority germline projects. PRIMARY RESPONSIBILITIES Strategic Study Design and Analysis Independently lead the design, analysis, and interpretation of clinical validation studies to support in vitro diagnostic approvals (e.g., CDx, 510(k), PMA, etc.) Regulatory Compliance Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as FDA. Drive statistical...

We are looking for an experienced Manager of Quality Management Systems to build, maintain, and improve our ISO 13485-certified QMS. In this role, you will own our internal and external audit program and our quality training program. You will keep the QMS compliant across all disciplines and support regulatory initiatives. You will also design and maintain quality programs that meet customer requirements for each product line.The ideal candidate brings deep ISO 13485 expertise, hands-on audit experience, and a strong understanding of the genomics or life sciences space. What You’ll Do Implement and maintain QMS procedures that comply with ISO 134852016...

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...

Quality Engineer. This position will support the Structural Heart business and will be based in Caguas, Puerto Rico. On-site position. This position will provide support to our Medical Devices / Structural Heart business . Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. 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...

Use Your Power for Purpose Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety. What You Will Achieve In this role, you will Evaluate corrective and preventive action (CAPA) responses to internal and external audit observations for adequacy, effectiveness, and timely completion. Ensure Quality Assurance policies, procedures, and quality system records remain current...

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

About 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 . Transcend is a global business transformation program that will modernize our foundational transactional processes and harmonize them into one “clean” ERP as a standardized platform for growth and efficiency gains. This program will simplify the Pharmaceutical ERP landscape...

We are searching for the best talent for a Manager, External Quality, External Contract Laboratories (ECL) Americas located in either Horsham, PA, Malvern, PA or Raritan, NJ . 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 Purpose Drives Quality Assurance, Compliance and Technical Support for External Quality...

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

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). USA Req# R-103874 Belgium/Ireland Req# R-105117 Switzerland Req# R-105118 The Senior Director, Quality Digital & Analytics is responsible for defining and executing a comprehensive strategy that leverages digital transformation and advanced analytics to enhance quality management and compliance across the Innovative Medicine sector. This position will oversee the establishment of...

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

Biosense Webster , Inc., part of the Medical Devices sector within Johnson & Johnson , is recruiting for an intern for its Medical Devices Regulatory Affairs organization . At Johnson & Johnson , we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health...

We anticipate the application window for this opening will close on - 21 Oct 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 - 26 Oct 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 - 30 Oct 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 Design Quality Engineer II in Released...

Undergrad Co-op - Quality, Manufacturing, Operations and/or Engineering What You Will Do Ready to make an impact? Join us in redefining the world through innovation! We are offering multiple co-op opportunities starting in January 2027. As a co-op, you'll collaborate with cross-functional teams, gaining hands-on experience and advancing your professional skills. You’ll work on meaningful projects and initiatives, contributing to the team’s success while developing your own potential in our Operations organization centralized in Puerto Rico's End-to-End Manufacturing Site. Measure and analyze current system and process performance. Drive improvements in operational efficiency and productivity across the organization, maximizing AI 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...

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. We are seeking a highly skilled and detail-oriented Process Quality Analyst to join our Process Engineering team. As the Quality Analyst,...

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,...

AstraZeneca is seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) team. The successful candidate will contribute to the advancement of our product pipeline by performing QC analytical method qualification, execute lot release testing, sample management and other assigned tasks. This position is essential for ensuring that the laboratory meets the high standards required for CGMP Quality Control. This position includes weekend technical support and may require non-traditional work schedules to support operational and business requirements. Scheduled work hours and shift assignments are subject to change. Essential Responsibilities Perform CGMP release...

Responsible to perform adequate and comprehensive qualification and validation of equipment, processes, products, and facilities at the Redwood City site to support the site goals and targets. Key Accountabilities Work effectively with others from diverse backgrounds and demonstrate capability to adapt to new, different, or changing requirements. Display strong moral principles and work ethics while demonstrating initiative. Maintain a professional presence and display responsible behaviors Knowledge and experience developing and leading CSV and Life-cycle management activities to support GxP conforming systems, facilities, manufacturing and laboratory systems Evaluate equipment and processes to identify critical parameters based upon potential impact on product...

Job Profile Description Provides independent, visible Quality Assurance leadership at the source of cell therapy manufacturing. This is a shift-based role scheduled for four days per week, Wednesday through Saturday. Partners with Manufacturing and supporting functions to apply risk-based quality judgment, resolve issues within established frameworks, and support reliable, compliant execution. Operates independently across qualified routine and moderately complex situations, influences cross-functional decisions, and strengthens quality culture through practical coaching, clear communication, and disciplined follow-through. Specific quality-system responsibilities and approval authorities are defined through applicable procedures, qualifications, and delegated authority. This is a shift-based role scheduled four days per week,...

The Senior Manager / Associate Director of Clinical Quality Assurance (CQA) will provide leadership for the qualification and ongoing quality oversight of CROs and other clinical service providers while providing clinical quality support for assigned studies. This role will partner cross-functionally to implement risk-based vendor oversight, monitor and address vendor quality and compliance risks, and provide pragmatic GCP guidance to study teams. This position will also support quality investigations, audits, CAPAs, and inspection readiness activities to ensure effective sponsor oversight and sustained clinical trial compliance. Responsibilities Lead and manage the qualification and ongoing quality oversight of CROs and other GCP/GCLP/GVP...

Quality Manager, CAPA The function of the Quality Manager, CAPA is to provide corporate-level leadership and guidance for Quality Systems matters related to nonconformance, investigation and C orrective And P reventive A ction (CAPA) processes and other related Abbott Quality System elements. This includes Business/Division support, quality and technical expertise and consulting activities globally. The incumbent must have a working knowledge of global regulations and industry standards related to nonconformance, investigation, and Corrective And Preventive Action (CAPA) processes. The incumbent should also have working knowledge and understand the relationship to other related Quality System elements, e.g., management responsibility, risk...

Our location in Sylmar, CA currently has an opportunity for an Electrical Development Quality Engineer II . This is a fully onsite role . A Development Quality/Design Assurance Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. WHAT YOU’LL DO Execute...

The Site Quality Leader is the senior quality authority for the site and a key member of the Site Leadership Team. The role is accountable for ensuring that all products manufactured, tested, and released from the Plymouth, MN and St. Paul, MN Structural Heart facilities meet global regulatory requirements and conform to the Abbott Structural Heart Quality System. In addition, the position is responsible for establishing and leading the quality strategy, driving regulatory compliance, and maintaining the Quality Management System for finished Structural Heart devices and components manufactured at Minnesota facilities. Establish and implement a site quality strategy aligned with...

The Senior Specialist, Quality Assurance BDQR is responsible for providing Quality oversight and technical support for analytical and process development activities supporting large molecule programs, while ensuring compliance with cGMPs, applicable worldwide regulations, and our Company requirements for supported area(s). The Senior Specialist applies a strong Quality mindset, partners with stakeholders, and supports compliant execution and decision-making across routine operations and quality events. Primary Responsibilities Provide Quality oversight and execute GMP/GxP quality assurance activities supporting manufacturing and testing operations, including material and batch documentation review and batch disposition. Provide Quality oversight of an evolving biologics clinical space by identifying potential...

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Specialist, Technician Biologist | Quality Control with In Vivo Release Testing (IRT) in our Manufacturing Division Quality Laboratory Operations Team. Position Responsibilities This role will perform testing in support of releasing vaccines...

The Specialist, WPLO Equipment Support Group (ESG) is responsible for the implementation, lifecycle management, and administration of laboratory equipment within assigned areas of Laboratory Operations. This position provides technical support for routine business activities and applies the Risk-Based Asset Management (RBAM) process to evaluate high- and medium-risk equipment. The incumbent partners with the Small Capital point of contact to develop forecasts and align funding for future risk mitigation, participates in projects as a lead or team member, and supports operational improvements, instrument qualification, implementation, and decommissioning activities. The Specialist serves as point of contact for assigned IPT laboratory areas and...

The Senior Specialist, WPLO Equipment Support Group (ESG) Senior Specialist IPT Lead is responsible for the implementation, life cycle management, and administration of laboratory equipment utilized within assigned areas of Laboratory Operations. Responsibilities include provide technical expertise to support run the business daily activities L e verage the RBAM (Risk Based Asset Management) process to assess high / medium risk equipment, collaborate with the Small Capital POC to work on forecasts to align funds for future risk mitigation, lead projects, implement operational improvements, support and / or have oversight over instrument qualification and implementation, and decommissioning. The ESG Senior Specialist...

We are searching for the best talent for a Counsel, Regulatory Law, Government Programs, to be based in Washington, DC or Raritan, NJ. Purpose Federal and state governments play a significant role as purchasers and payors of Johnson & Johnson products. This attorney will serve as an enterprise-oriented legal advisor who shapes strategy, influences decisions across organizational boundaries, and creates clarity in complex and rapidly evolving legal and regulatory environments pertaining to government transactions, federal procurement, pricing, transparency and compliance requirements affecting Johnson & Johnson operating companies. The role requires practical, solutions-oriented advice that supports business objectives while managing legal,...

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

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Quality Operations Technician. Purpose Responsible for conducting technical quality assurance inspections, quality issue resolution, product containment, and supporting quality improvements for production processes and standards. You will be responsible for Supports v Quality Operation functions including CAPA/NC initiatives, Quality...

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

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...

We anticipate the application window for this opening will close on - 22 Oct 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 - 30 Oct 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 Supplier Quality Engineering team within Cranial...

We anticipate the application window for this opening will close on - 21 Oct 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 Supplier Quality within Medtronic,...

Sr Executive Assistant - Quality What you will do Let’s do this. Let’s change the world! In this vital role you will provide professional and administrative support to a Vice President or above. Work assignments are complex in nature, where considerable tact, judgment, creativity and initiative are required in resolving problems. Organize workflow by reviewing, prioritizing, and distributing correspondence to ensure the executive's attention is focused on critical matters. Screen and direct incoming calls, correspondence, and visitors, exercising discretion and sound judgment. Respond to routine inquiries and provide information independently, allowing the executive to focus on strategic priorities. Maintain organized...

The Quality Control Associate III will support the management team to ensure that laboratory and Quality systems within the QC Chemistry department remain in compliance with Biogen Idec and industry cGMP standards. Additionally, the Associate III will actively support the completion of all departmental milestones associated with clinical and commercial product manufacture and testing. The Quality Control Associate III has frequent interaction with the Supervisor, Manager and Associate Director of QC Chemistry as well as peers (Associate I, II, III) with the purpose of performing release/stability testing, leading investigations, discussions pertaining to strategic initiatives, personnel development, and testing-related issues. Importantly,...

This position reports to the Senior Director/Director, US Ethics & Compliance Advisor and is hybrid, located onsite in Foster City, CA. As an Associate Director, U.S. Ethics & Compliance Advisor, Medical Affairs at Gilead, you will... Work with the Senior Director to provide expertise in healthcare compliance ensuring that Medical Affairs activities align with the highest ethical and compliance standards. Partner with leaders across Legal, Commercial, Medical, Clinical Development to build and integrate the compliance program into the US Medical Organization. Participate in activity reviews consistent with established policies and processes, advising on ethics and compliance insights and recommendations, including...

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

The Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant. Responsibilities Assist Validation Engineer in the validation and certification of all new process equipment and periodically review all certified systems to assure the capability of meeting quality requirements. Responsible for implementing and maintaining the effectiveness of the Quality...

Position In partnership with the Director of Process Management for Clinical Research & Development, to whom this role reports, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational quality management and inspection readiness activities across assigned clinical programs within Eikon’s clinical development portfolio. The CQOM oversees clinical quality operations across assigned clinical programs, embedding quality-by-design (QbD) principles, risk-based quality plans, and vendor oversight into Eikon’s clinical trials. This includes ensuring consistent execution of QbD principles across assigned clinical studies, facilitating identification of Critical to Quality (CtQ) factors and associated risk assessments, and establishing and actively maintaining...

This position works out of our New Brighton, MN location on our Structural Heart team. Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements. What You’ll Work On Contributes to the development, maintenance and improvement of division supplier development quality program policies, procedures and forms. May provide coaching and mentoring for technical team personnel. Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers...

We are recruiting for a Regulatory Affairs Operations Specialist to join our Abbott Vascular team on-site in Temecula, CA. This is a unique role where you will partner with external and internal stakeholders to maintain the quality system current and effective in alignment with the dynamic regulatory landscape and new/evolving requirements. The position is within the Regulatory Affairs Operations organization rather than direct regulatory submission preparation; this role involves supporting Quality System and Compliance initiatives such as Audit Readiness Program Management, including coordination of audit requests, Emerging Regulatory Issues and implementation of conformance, needs involving multiple therapies or device families,...

The position of Quality Control Team Leader is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will perform work required to ensure Company product quality is maintained at standards set forth by Company Quality System and mandated by regulatory agencies such as the FDA, ISO, and USDA. The focus areas for a Quality Control Team Leader include but are not limited to overseeing and coordinating the work of QC technicians; enforcing policies, procedures and work rules; manufacturing batch record review and approval. 2nd Shift 2pm-1030pm M-F What You'll Do Coordinates, facilitates and...

This position works out of our Des Plaines, IL location in the Abbott Molecular , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Senior Specialist Quality Assurance - Supplier Quality will support in the selection, approval, and maintenance of the division's approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities. What You’ll Work On...

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

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

That’s what makes us Genentech / Roche! The Opportunity Are you ready to shape the future of quality management in healthcare? As a Quality Lead within our Pharma Development Quality (PDQ) division, you will support the Roche/Genentech organisation by developing and delivering robust Quality Assurance strategies, audits, and conclusions across molecules in development, post-approval products, and global processes. You will act as a trusted partner, ensuring our operations maintain the highest standards of compliance while directly influencing how we bring innovative therapies to patients safely and efficiently. In this dynamic role, you will apply a risk-based approach to Quality Assurance...

USE YOUR POWER FOR PURPOSE The Senior Director, Quality Management Systems is responsible for developing and executing the product strategy, roadmap, governance, and value delivery for Pfizer's global Quality Management digital product portfolio, aligned to the Digital Quality strategy and investment priorities established by the Digital Quality Solutions Lead and Pfizer Quality leadership. The role provides product leadership for the Veeva Quality Vault ecosystem, including QualityDocs and electronic Quality Management System (eQMS) capabilities, alongside complementary quality and records management solutions such as SDS and EDES. The portfolio also includes AI-enabled quality solutions that support quality management processes, including DEVI, CLAIRE,...

Use Your Power for Purpose At Pfizer, everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions will be instrumental in ensuring that our products meet the highest standards of quality and safety. What You Will Achieve In this role, you will Serve as Quality Assurance oversight for the validation program at the Andover, MA Pfizer site. Primary...

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. Department Quality Control Microbiology (QCM) is responsible for testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation. Quality Control is also responsible for assisting in site wide studies and projects. This position is responsible for performing routine and complex testing of in-process...

The Senior Regulatory Affairs Specialist will be an instrumental member of the Regulatory Affairs team supporting on-market in vitro diagnostic (IVD) products in the United States and international markets. This role is responsible for supporting post-market regulatory compliance activities, including adverse event reporting, field actions, recalls, post-market surveillance, and regulatory assessments. The individual will serve as a key regulatory partner to cross-functional teams, providing guidance on regulatory requirements, risk evaluations, and reporting obligations. Key responsibilities include conducting timely assessments of potential adverse events and field actions to determine regulatory reportability, supporting MDR and recall decision-making, coordinating regulatory reporting activities, developing...

We are searching for the best talent for Senior Manager, Quality Management Systems to join our MedTech Quality organization located in Santa Clara, CA or Cincinnati, OH. 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 The Senior Manager, Quality Management Systems (QMS) is responsible for leading the strategy, governance, continuous improvement, and global compliance of the Quality Management System across Auris sites. This role serves as a key leader in...

The Senior Director, Quality — Post-Market Surveillance and Innovation Excellence is a senior quality executive responsible for shaping and executing the quality strategy that supports the Heart Recovery platform and Innovation Excellence organization. This leader provides enterprise-level direction for Complaint Management and Post-Market Surveillance, with accountability for organizational capability, governance, regulatory compliance, and sustained operational performance. The role establishes an integrated product lifecycle management framework that connects post-market intelligence with risk management, design controls, change control, CAPA, manufacturing, and supply chain quality to protect patient safety, strengthen product performance, and enable timely, risk-based business decisions across the marketed product portfolio....

We anticipate the application window for this opening will close on - 17 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Across our global Neuroscience portfolio, we advance...

We anticipate the application window for this opening will close on - 19 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Quality Engineer II will support...

We anticipate the application window for this opening will close on - 20 Oct 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...

We anticipate the application window for this opening will close on - 24 Oct 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 Our Neuroscience portfolio includes the Neuromodulation and...

We anticipate the application window for this opening will close on - 30 Oct 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 Responsibilities may include the following and other...

The Director, Translational Operations and Regulatory Integration is a leadership role responsible for enabling the successful execution, regulatory readiness, and operational excellence of Sarepta's Translational Biology portfolio across gene therapy, RNA, and emerging genetic medicine programs. This individual serves as a strategic connector across Research, Translational Biology, Clinical Development, Development Operations, Regulatory Affairs, and external partners to ensure biomarker and translational strategies are translated into actionable, compliant, and execution-ready plans. The role provides leadership for translational operations, regulatory integration activities, and cross-functional program execution, ensuring that key milestones, regulatory commitments, clinical biomarker activities, and organizational priorities remain aligned and on...

This position is office based/hybrid located in Foster City, CA or Parsippany, NJ. As the Sr Director, U.S. Ethics & Compliance Advisor, Medical Affairs, you will report into the Executive Director, U.S. Ethics & Compliance Advisor and you will... Act as the key point of ethics and compliance support for relevant US Medical Affairs activities Partner with leaders across Legal, Commercial, Medical, Clinical Development to build and integrate the compliance program into the US Medical Organization. Advise and provide guidance on Ethical Medical-Commercial interactions Participate in activity reviews consistent with established policies and processes, advising on ethics and compliance insights...

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 Regulatory Affairs Intern will support the Regulatory Affairs team in preparing documentation, tracking submissions, and assisting with project coordination....

The Quality Center of Excellence (COE) Senior Specialist role will be involved in providing support for the Quality COE structure, ensuring the processes conform to Close collaboration with high-performance talent from our Company global team and the biotechnology industry to develop and execute multiple Quality Assurance systems and processes will be key, and the successful candidate will be a an individual and team member the future of our Company antibody drug conjugates and high potent compounds through a Quality culture that delivers unconstrained supply, that is Right First Time to patients worldwide. As necessary and when applicable, provide training...

The Patient Safety Medical Director will provide medical safety expertise for assigned products, pre- and post-approval. The role will optimize patient safety of Vertex products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of Safety activities through the product life cycle. Key Duties and Responsibilities Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development) Responsible for the safety assessment activities of assigned products under the supervision of a Global Patient Safety (GPS) Disease-area Safety Head Autonomously monitors...

2027 Spring Intern - PTQ Quality Processes Department Summary Global Quality and Compliance (PTQ) ensures we deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is a competitive advantage for Roche. You will report to the US Internship Program Manager in the PTQ Quality Metrics and Business Insights Function. The ideal candidate is a self-starter deeply curious and energized by learning. You should be comfortable with working through ambiguity and are able to prioritize and manage multiple demands and commitments. Your role will be to help...

SENIOR ENGINEER, SYSTEM OWNER COMPLIANCE What you will do In this vital role you will partner across Facilities & Engineering, Manufacturing, Quality, Validation, Environmental Health & Safety, Supply Chain, Digital Technology & Innovation, and Capital Projects to ensure engineering activities support operational excellence while maintaining a constant state of inspection readiness. The successful candidate will demonstrate strong engineering judgment, ownership, technical leadership, and a continuous improvement mindset while driving compliance, reliability, and exceptional customer service. Provide system ownership for Biopharmaceutical compliance programs. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the facility systems. This may include...

We anticipate the application window for this opening will close on - 19 Oct 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 In this role as a Software Quality...

We anticipate the application window for this opening will close on - 16 Oct 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 Ablation team within the Electrophysiology...

Johnson & Johnson is currently seeking a Experienced Engineer - Thermal to join our Manufacturing Science and Technology team located in Wilson, NC. J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. Our expertise in Innovative Medicine is informed...

We are searching for the best talent for Quality Control Lead - Swing Shift , located in Santa Clara, CA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Purpose The Quality Control Lead – Swing Shift supports daily IQC operations during the 200 p.m. to 1030 p.m. PST shift and serves as the primary operational point of contact for the shift. This role coordinates incoming inspection and material-release priorities, provides...

Johnson & Johnson is currently seeking a Experienced Engineer, Process Engineering to join our Manufacturing Science and Technology team located in Wilson, NC. J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. Our expertise in Innovative Medicine is informed...

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 as a Director, Site Regulatory Compliance Advanced Therapy (AT), to be located in Raritan, NJ; Horsham, PA or Malvern, PA. Purpose The Director, Regulatory Compliance is the senior Site-Based Compliance leader responsible...

Johnson & Johnson is currently seeking a Experienced Engineer- Process Validation Support (PVS) to join our Manufacturing Science and Technology team located in Wilson, NC. J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. Our expertise in Innovative Medicine...

This position works out of our La Jolla, CA location in the Cancer Diagnostics Division. The Senior Bioinformatics Quality Engineer is responsible for ensuring the quality of the medical device software for IVD, IUO and LDT products. This entails executing verification and validation processes to ensure quality of products. The Sr Bioinformatics Quality Engineer will be involved in testing, verification, and validation of the bioinformatics pipelines in all phases of system development. The position is responsible for ensuring the creation and execution of verification plans, protocols, and reports. Working in a team setting, this role will contribute to the implementation...

Why Genentech We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world’s most complex health challenges and transforming society. The Opportunity As the Principal Clinical Quality Compliance and Policy Lead, you will serve as a strategic advisor embedded across Early Clinical Development (ECD) study teams. In this leadership role, you will champion a proactive quality culture, translating complex global regulatory requirements into pragmatic, robust clinical compliance strategies that advance our groundbreaking early-stage clinical trial pipeline....

Why Genentech We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world’s most complex health challenges and transforming society. The Opportunity As a Quality Partner within Early Clinical Development (ECD) Quality, you will champion a proactive, risk-based quality culture that enables innovative science to move safely and efficiently to patients. You will serve as the primary Good Clinical Practice (GCP) quality advisor and strategic partner to early-stage clinical trial study teams and external partners. In...

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...

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

The Associate Specialist of Regulatory Planning & Publishing works closely with various stakeholders of regulatory and safety submissions to assist in activities related to planning, execution, and management of delivery of high quality and timely regulatory submissions. This position is based at the Philadelphia, PA, WeWork Office, on a hybrid bases- 3 days in office; The incumbents will be required to commute to the Philadelphia, PA, WeWork Office, for these 3 days. The responsibilities of the incumbent may include the following Maintain accountability for use of established planning and tracking practices and systems. Participate in pilots for new tools and...

The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible for strategic and operational Quality oversight across multiple complex programs. This role leads day-to-day quality operations, supports the execution of new initiatives, and applies sound judgment to resolve complex quality and compliance issues. The role provides Quality oversight for drug substance disposition from development through process performance qualification, ensuring decisions align with patient safety, product quality, regulatory expectations, and business continuity. This role serves as a visible Quality partner to Product Quality Leads, MSAT, Regulatory Affairs, operational stakeholders, CDMOs, and suppliers. The successful candidate...

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 Facility Quality Systems Specialist is a senior-level quality systems professional within Global Facilities Services (GFS) who owns facility Quality...

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...

In this vital role the Senior Engineer-Validation will serve as a technical lead/subject matter expert (SME) and lead the development and implementation of the Validation strategy at the Amgen North Carolina (ANC) manufacturing facility. Specifically, this role has responsibility for developing and generating documents such as the site’s Validation Master Plan, validation plans, equipment qualification protocols/reports, among others. In addition, the position will be accountable for completing landmarks related to results for autoclave performance qualification, cleaning validation, and validation maintenance. Responsibilities Lead a team responsible for implementing and maintaining the facility cleaning validation and sterilization program. Provide technical support and...

This position works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Senior Specialist Quality Assurance - Biochemistry leads quality assurance initiatives by ensuring regulatory compliance, managing risk, driving quality system effectiveness, supporting product lifecycle quality activities, and providing technical leadership across cross-functional teams. What You’ll Work On Maintain and...

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 leadership and oversight for manufacturing daily activities, ensuring products and manufacturing processes meet regulatory, quality,...

We anticipate the application window for this opening will close on - 19 Oct 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 Surgical Sutures Manufacturing business within Surgical...

In the race for the future of health – The Sanofi mRNA Center of Excellence (CoE) At Sanofi, we chase the miracles of science, and we know mRNA has a role to play in the future of health. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines and treatments for more people faster than before. That’s why we’re looking for bold, optimistic world-changers to join our mRNA Center of Excellence. We’re investing €400M a year into the new Center, hiring a team of 450...

DePuy Synthes is recruiting for a Professional, Quality Steward located in New Brunswick, NJ or West Chester, PA or Palm Beach Gardens, FL or Warsaw, IN or Raynham, MA. Job Overview The Professional, Quality Steward is an established and productive individual contributor within the Cybersecurity function, accountable for embedding Secure by Design principles into the DePuy Synthes medical device and connected product portfolio. This role serves as the quality and security steward across the total product lifecycle — partnering with R&D, Product Management, Engineering, Regulatory Affairs, and Quality to ensure security requirements are defined early, designed in, verified through testing,...

We are searching for the best talent for a Director, Regulatory Affairs to join our Orthopaedics team located in Palm Beach Gardens, FL, West Chester, PA, Warsaw, IN or Raynham, MA. Purpose The Director, Regulatory Affairs is responsible for setting regulatory strategy, and in partnership with cross-functional teams, driving excellence in product innovation, launch and portfolio management. This position is also responsible for providing direction and leadership to the Regulatory Staff in the development and implementation of global regulatory strategies and processes to assure timely commercialization of products in key markets in compliance with current and appropriate worldwide regulatory expectations....

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

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

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...

At AstraZeneca, we are united by a shared commitment to transform the lives of patients through science. Within our Cell & Gene Therapy organization, we are building next-generation capabilities that combine scientific innovation, advanced manufacturing, digital technologies, and regulatory excellence to deliver potentially life-changing medicines. As Manager, Regulatory & Technical Writing, you will play a critical leadership role in translating complex CMC and technical data into clear, compelling, and submission-ready regulatory documentation supporting AZD0120 and future Cell & Gene Therapy programs. This position offers a unique opportunity to contribute directly to BLA readiness, global regulatory submissions, health authority interactions, and...

Schedule This onsite position operates on 10-hour shifts from Sunday through Wednesday during the first shift (8AM-6PM), with some occasional support required outside of those hours. About This Role We are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at RTP drug substance manufacturing facility. The Sr. Associate I is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Associate I performs and trains other team members on the microbial testing of all in-process drug substance, EM/UM, and raw materials samples. Additionally this...

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 Opportunity Reporting to the Executive Director, Head of Regulatory Project Management, you will support the planning, coordination, and execution of complex global regulatory filings activities across the development portfolio. You will serve as a strategic partner to Regulatory Affairs leaders and cross-functional teams, ensuring regulatory strategies are translated into integrated, actionable plans that support successful health authority interactions and major submission milestones. You will facilitate alignment across functions, proactively identify risks and dependencies, and ensure teams remain focused on critical deliverables and timelines. You will play a key role in advancing Regulatory Project Management best practices, supporting...

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

The Head of US Patient Safety is accountable for the overall strategic direction, operational execution, and holistic performance of the PV system for the USA, ensuring full alignment with International Patient Safety (IPS) priorities and business needs. Operating in close partnership with Genentech, the Head of US Patient Safety serves as the primary steward of the affiliate PV system and safety risk management. In this role, core responsibilities will include Strategy Lead the Affiliate Patient Safety strategy, collaborating with cross-functional leaders to prioritize initiatives that maximize patient and business impact. Additionally, serve on the IPS Leadership Team to co-own...

The Principal Quality Systems Specialist is responsible for providing quality oversight and expertise of the pharmaceutical quality systems for the Cell and Gene Therapy team based in San Diego, CA. You will also provide quality leadership of the development, implementation, and on-going management of the quality management system and programs including risk management, change management, planned and unplanned events, training, documentation and records management, and data integrity. Lastly, you will support and/or lead relevant strategic initiatives, as applicable. The Opportunity Coordinate work across systems, functions, and sites to harmonize workflow, clearly identify responsibilities, and optimize cross functional team member participation...

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. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team...

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,...

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 Associate Quality Assurance What you will do Let’s do this. Let’s change the world! The role is fully onsite in Thousand Oaks, CA, and requires the ability to lift 30+ pounds and pass a vision assessment for inspection work. Candidates must be comfortable working with raw materials and components, mainly chemicals, and may have to work in the sampling suite for extended periods of time. Previous experience with GMP is a plus but not mandatory, as training can be provided. Candidates of all backgrounds and experience levels will be considered if they demonstrate the right attitude and interest in...

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find...

The Contract Compliance Analyst III will facilitate contract implementation and revenue pull-through activities, both proactive and reactive, with internal and external parties. This position will ensure the public and private payer reimbursement. The role is also fundamental in reviewing that billing and payment processes are efficient, timely, and in compliance with corporate goals, contracts and/or regulations. This position will facilitate and manage contract implementation for operations and partner with Managed Care to develop and maintain agreements that provide medical providers and patients with access to our assays while aligning with Exact Sciences goals and objectives. Location This is a remote...

We anticipate the application window for this opening will close on - 31 Oct 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...

We anticipate the application window for this opening will close on - 16 Oct 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,...

We anticipate the application window for this opening will close on - 23 Oct 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 Design Quality Engineer II in Released...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer , to be based in Danvers, MA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Purpose The Senior Manager, Health Care Compliance Officer will be responsible for collaborating with Cardiovascular business partners and providing strategic guidance on activities and processes that have health care compliance-related implications. The Health Care Compliance Officer will provide direction and...

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 a Quality Control Analyst! This position will be located in Malvern, Pennsylvania. Purpose The QC Analyst, Systems specialist, position supports the overall QC organization and is responsible for local systems management in the QC organization and communication with global workgroups within the systems area. This position requires organizational leadership, interpersonal skills, technological savvy, and technical writing...

This position works out of our Lake Forest, IL location in the Rapid and Molecular Diagnostics Division (RMDx) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. The Senior Quality Auditor is responsible for developing and executing the Infectious Disease (ID) Business Unit (BU) audit program that ensures performance of independent internal compliance audits for RMDx entities (including affiliates) and suppliers as required. Duties will principally be within his/her region, but it will be...

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

Independently perform analyses and implement data, software, or technology solutions to deliver precise, reliable, and reproducible products in a timely manner, under the direction of a more senior leader. Demonstrate technical precision and strong analytical skills. Possess good understanding of software development and technology infrastructure (including servers, storage, network connectivity, and virtualization/cloud environments), and general understanding of data integration and warehousing, and data analysis and visualization tools. Responsibilities Perform routine tasks competently and independently and generate reliable and consistent results. Analyze and critique results, noting significant variances or deviations. Troubleshoot algorithms, protocols, and software programs. Demonstrate skill in multiple techniques...

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...

POSITION SUMMARY Regulatory Advisor - FDA Pharma & IVDR Natera is a clinical genetic testing company specializing in non-invasive, cell-free DNA (cfDNA) and liquid biopsy testing . The Regulatory Advisor plays a key role in developing and driving regulatory strategy on behalf of the regulatory affairs (RA) team, specifically focusing on FDA Pharma and IVDR initiatives. At Natera, we remember there is a person behind every sample . This role combines strong technical knowledge and an understanding of regulatory requirements (US FDA, CAP/CLIA/NYS, EU, or Japan) to support the approval and registration of products that proactively inform disease management...

Job Summary The Sr. Director and Head of GDMS Process and Quality Management is responsible for the development, implementation, oversight, and maintenance of the GDMS process and training compliance framework; business processes; associated functional process training; and quality management activities. Reporting to the Head of Global Data Management and Standards, sets the vision for the organization and is responsible for the timely and quality delivery of GDMS Process & Quality Management services. Responsibilities Establishes and maintains the GDMS Process & Quality Management operating model, governance cadence, priorities, decision rights, and escalation pathways to drive consistent execution and accountability Serves as...

The Director, Clinical Quality & Development Operations (CQDO) Operational Excellence provides strategic leadership and operational oversight of Global Clinical Operations (GCO) Ancillary Supply Management, Phase 1 Center of Excellence Alliance, Safety Distribution as well as Training & Development programs. The Director drives the execution of departmental strategy, ensuring robust processes, inspection readiness, and compliance across all areas. In addition, the Director serves as a key liaison, that overall supports GCO, advancing business processes and systems to drive effectiveness, standardization, and productivity. Key Duties and Responsibilities Defines and executes the overarching vision and strategy for Operational Excellence ensuring alignment with GCO...

Kickstart Your Career at Vertex! Are you ready to make a real impact? At Vertex, our mission is to tackle serious diseases and to change lives, for the better, for the future. Our aim is to give you the skills, insights, and career guidance to be an important part of that future; to turn your potential into progression. As a Vertex intern or co-op, you’ll work on meaningful projects, collaborate with talented teams, and learn from industry leaders. We’re passionate about innovation, inclusion, and supporting your growth—inside and outside the lab. Why Vertex? Real Projects You’ll work on assignments that...

EXAMPLE RESPONSIBILITIES Set the global Digital Quality strategy and roadmap Define the target state, strategic themes, capability model, and multi-year roadmap for Digital Quality. Maintain a portfolio of initiatives aligned with Quality objectives, regulatory priorities, enterprise architecture, and available investment. Establish measurable outcomes, including compliance effectiveness, cycle-time reduction, right-first-time performance, user adoption, data quality, and realized benefits. Lead end-to-end Quality process mapping and optimization Map current- and future-state processes across sites, regions, and GxP domains, including roles, decisions, controls, systems, data, handoffs, pain points, and performance measures. Identify opportunities to simplify, standardize, digitize, automate, or retire processes before selecting technology....

Key Responsibilities Validation and assurance strategy Develop risk-based validation or assurance plans based on intended use, GxP impact, process risk, system complexity, novelty, and supplier capability. Define lifecycle deliverables, acceptance criteria, evidence expectations, roles, and approval requirements. Apply critical thinking to focus effort on functions that could affect patient safety, product quality, record reliability, or regulatory compliance. Use supplier documentation and automated evidence when suitable, complete, reliable, and approved for use. Lifecycle execution and oversight Lead or approve GxP assessments, validation plans, user requirements, specifications, risk assessments, traceability, test strategies, test evidence, summary reports, and release decisions. Ensure requirements are...

In this vital role you will be part of ANC’s Manufacturing Support team, and lead cleaning validation teams for both the existing Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and the new Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant. This requires managing cleaning validation teams supporting manufacturing plants in different lifecycle phases. It is a highly visible role across the site with the key responsibilities of working cross-functionally to ensure compliance of cleaning validation program to regulatory expectations, driving continual improvement, and maintaining alignment to network lessons learned and best practices. This role will also offer...

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 feel like you’re part...

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...

DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Supplier Quality Engineer to be located in Palm Beach Gardens, FL . 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 The Sr. Supplier Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of DePuy Synthes products. Works collaboratively with management...

Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs Location South San Francisco -CA, USA, or Gaithersburg -MD, USA Are you ready to steer the global regulatory strategy for high-visibility cell and gene therapy programs and translate breakthrough oncology science into approvals that reach patients faster? This role leads end-to-end strategy from current development stage through BLA submission, shaping competitive labels and leveraging expedited pathways to address significant unmet need in multiple myeloma and beyond. You will serve as the senior regulatory voice on pivotal programs, often in a dual capacity as Franchise GRL and regional lead, guiding cross-functional teams...

Global Regulatory Affairs Director Location Gaithersburg At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days...

The Associate Director, Regulatory Affairs, supports products in the Oncology therapeutic area as part of a regulatory team. The individual will have excellent communication and collaboration skills and will work closely with a global regulatory lead(s) to help develop and implement a global strategy for registration and/or maintenance of products. Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing submissions, protocol review, and conducting research on regulatory guidance's or competitive intelligence. The individual will have responsibility for driving results for his/her assigned projects through application of regulatory science...

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...

Director, External Manufacturing Regulatory Compliance Oversight Location US Johnson & Johnson Sites Reports To Senior Director, External Manufacturing Regulatory Compliance Oversight Travel- Up to 25-40% (Global) Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at The Director, External Manufacturing Regulatory Compliance Oversight, provides independent regulatory compliance oversight, risk visibility, inspection-readiness...

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

We anticipate the application window for this opening will close on - 19 Oct 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 As the Regulatory Affairs Manager, you will...

We anticipate the application window for this opening will close on - 19 Oct 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 position is located in Lafayette, CO...

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 a Global Trade Compliance Manager, you will be responsible for overseeing and managing daily Trade Compliance operations within the US/ Canada...

The Triage Order Quality Associate Level II (TOQII) position is responsible for the accurate and timely work of filing insurance claims for Abbott Cancer Diagnostics. This role will demonstrate medical insurance knowledge by determining initial and/or ongoing eligibility, coverage, and related insurance reimbursement order details, including commercial, government, and all various plan coverage. This role will identify order and reimbursement deficiencies, route orders for appropriate actioning and assist with triaging, and document actions taken within the systems for claims lifecycle tracking. This role will be responsible for claims escalations that TOQI are unable to resolve in addition to working “bulk”...

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...

Associate Quality Assurance What you will do Let’s do this. Let’s change the world! The role is fully onsite in Thousand Oaks, CA, and requires the ability to lift 30+ pounds and pass a vision assessment for inspection work. Candidates must be comfortable working with raw materials and components, mainly chemicals, and may have to work in the sampling suite ( clean room) for extended periods of time. Previous experience with GMP is a plus but not mandatory, as training can be provided. Candidates of all backgrounds and experience levels will be considered if they demonstrate the right attitude...

Associate Quality Control What you will do In this vital role you will execute and review analytical testing in our cGMP laboratory. The role will be based out of Amgen Rhode Island and will work under the mentorship of the hiring manager. It is an administrative shift, Monday through Friday. The Raw Material Centralized Testing team provides analytical expertise in testing raw materials to meet Amgen specifications and ensure a constant supply of raw materials for Amgen products. The laboratory employs a variety of test methodologies that utilizes sophisticated equipment including HPLC, GC and ICPMS. The team provides these...

This is a Pipeline requisition for future opportunities in 2026 & 2027. Associate Manufacturing & Quality Engineer for Abbott in Puerto Rico. The Associate Manufacturing Engineer or Associate Quality Engineer serves as a key engineering resource supporting manufacturing operations. This role collaborates closely with Supervisors, Engineers, and Operators to drive continuous improvement initiatives, resolve technical challenges, and support operational excellence. The incumbent is responsible for contributing to quality, safety, compliance, productivity, and process performance objectives while acting as an engineering representative within the manufacturing environment. The role may also include sustaining engineering responsibilities to support the long-term effectiveness...

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

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...

Lead, Quality Engineer This position will be based out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. As the Lead Quality Engineer, you will be responsible for owning complex investigations associated with trends and emerging issues associated with product complaints, captured in the CAPA system. This role requires a strong technical understanding of the product, investigation methods, and can work...

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 deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Regulatory Site Office, Vaccines will work closely with the Manufacturing and Supply teams and CMC colleagues on Vaccines based projects to achieve submissions and approvals in key markets and to maintain regulatory compliance for License registrations. The RSO management and position are based in Swiftwater, PA USA. This is...

Principal Quality Engineer The Principal Quality Engineer will be the liaison to cross function departments (e.g. Research and Development, Operations and etc.) with respect to investigations and/or results of investigations related to complaints. The lead is responsible for providing recommendations on product improvements as well as serve as the technical lead on large CAPA investigations where the incumbent will develop test methods to identify root/potential causes of complaints. Must be able to analyze data and assist in interpreting the data. Develop and implement investigation process improvements. What You'll Work On Responsible for implementing and maintaining the effectiveness of the...

The Senior Manager, Process Excellence within Regulatory Affairs , is responsible for managing key process excellence and issue management activities that support compliant, efficient, and inspection-ready Regulatory Affairs operations. This role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements. Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness and audit/inspection response activities, and management of change plans for legacy company integrations into Regulatory Affairs business processes. Responsibilities Manage the Regulatory Affairs Issue and CAPA Management system (RAIM)...

The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. The Senior Manager assures that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs.This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. Responsibilities Responsible for a...

The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. The Senior Manager assures that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs.This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. Responsibilities Responsible for a...

The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. The Senior Manager assures that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs.This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. Responsibilities Responsible for a...

The Associate Director, Regulatory Affairs US Advertising and Promotion-Oncology is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business. This individual identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project...

The Associate Director, Regulatory Affairs US Advertising and Promotion-Oncology is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business. This individual identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project...

The Associate Director, Regulatory Affairs US Advertising and Promotion-Oncology is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business. This individual identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project...

The Associate Director, Regulatory Affairs US Advertising and Promotion-Oncology is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business. This individual identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project...

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

At 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 Counsel, AI Governance, Law & Compliance provides day-to-day legal and compliance support for the design, development, deployment, and ongoing...

Johnson & Johnson is currently recruiting for a Director, Regulatory Compliance- RAD! This position will be located in Santa Clara, CA. The Director, Regulatory Compliance – RAD provides independent, strategic regulatory compliance oversight for the RAD business, with particular emphasis on robotics-enabled medical technology, software and software-enabled devices, connected-device and product-cybersecurity compliance, and Health Authority/Notified Body inspection readiness and management. The Director interprets current and emerging regulatory requirements, standards, and regulator expectations; translates them into risk-based compliance strategies; and provides independent advice, challenge, escalation, and oversight across the product and quality-system lifecycle. The role partners with Quality, Regulatory Affairs,...

Johnson & Johnson is currently recruiting for two Analyst Quality Systems! This position will be located in Raritan, NJ. Key Responsibilities Complete quality system execution activities, including but not limited to Document/Records Management and Data Integrity. Act as a liaison between site and above site activities. Support document lifecycle and perform site superuser activities. Identify improvement opportunities and elevate potential risks to management. Actively assist in Audit, Investigation and Change Control related activities. Participate in department optimization efforts. Take the lead on selected projects assignments following them through closure. Update Standard Operating Procedures and related documents. Drive alignment and efficiencies...

Position Senior Manager, Quality Control Department Name Quality Control Reports To Site Quality Head Location Malvern (primary) and Spring House (secondary), Pennsylvania About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at The Senior Manager, Quality Control (QC) is a strategic, multi-site people leader accountable for the...

The Regulatory Affairs Specialist works out of our Abbott Park, IL location in the Transfusion Medicine Business. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. What You’ll Work On Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team. Supports necessary regulatory activities required for product market entry and on-market support of instrument hardware and software. Work with Regulatory and CFT to improve efficiency in regulatory...

The Manager Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes pharmaceutical products, medical devices, cosmetics, combination products and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of responsibility may include supplier qualification and approval, supplier risk management, , supplier change management, , and Approved Supplier List (ASL) governance. This position will also translate strategy into tactical objectives to deliver strategic plans and regulatory updates. This position will ensure that all product, process or system related quality activities from raw material inspection through...

Responsible for quality of assigned combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Primary products include breast implants, ocular implants, consumer eyecare products, dermal fillers, infusion pumps and enteral tubing. Products may be produced by AbbVie plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships. Collaborates to develop the appropriate regulatory strategies for product brands in concert with Regulatory Affairs. Ensures delivery of quality elements needed to facilitate on-market support for the combination...

Purpose Responsible for quality of assigned New Product Introduction (NPI) combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include combination products and medical devices. Products may be produced by AbbVie plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships. Develops the appropriate Regulatory, Quality and Product Development strategies for NPI products in concert with Regulatory Affairs, marketing, Product Development and other cross-functional stakeholders. Responsibilities Serves as the primary quality lead for project...

The Principal Quality Engineer – Digital Regulatory Assurance is responsible for providing regulatory assurance and quality oversight for IT applications, infrastructure platforms, and technology solutions operating within a regulated life sciences environment. This role serves as a senior subject matter expert in Software Lifecycle (SLC) processes, Computer Software Assurance (CSA), infrastructure qualification, regulatory compliance, and quality risk management. The incumbent is responsible for modernization of quality processes through automation, data-driven monitoring, dashboards, and AI-enabled solutions that improve compliance effectiveness, streamline SLC activities, and strengthen inspection readiness. This position bridges implementing regulatory requirements, technology solutions, and improvements to processes by enabling...

Senior Director Design Quality JOB SUMMARY The Senior Director, Design Quality will report directly to the Vice President, Quality & Compliance for the Heart Recovery business. This role is responsible for providing strategic and operational leadership for Design Quality across the product lifecycle, including new product development, sustaining engineering, design changes, and lifecycle management activities. The Senior Director, Design Quality will partner closely with Research & Development, Regulatory Affairs, Clinical, Manufacturing, Supply Chain, Risk Management, and Commercial teams to ensure products are designed, developed, and maintained in compliance with applicable global regulations, standards, and Johnson & Johnson quality requirements. This...

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 Staff Quality Engineer – Leads, plans, supervises, and coordinates quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards. As needed, assists to develop quality-engineered systems and products, and support qualification and validation activities. Will be considered a subject matter expert (SME) on Quality matters, relevant Quality tools and will work on...

Johnson & Johnson is hiring for a Principal Analyst, Healthcare Compliance – Circulatory Restoration to join our team located in New Brunswick, Raritan NJ or Santa Clara, CA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for...

We anticipate the application window for this opening will close on - 16 Oct 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...

MANAGER QUALITY CONTROL I – NIGHT SHIFT NOTE This is a Wednesday - Saturday schedule night shift. What you will do In this vital role you will play a key role in the Quality Control team as the Manager for night shift support. Reporting directly to the Director of Quality Control, the Manager, Quality Control I (Night Shift) is an experienced QC professional who provides independent technical execution and shift-level leadership within a GMP-regulated laboratory environment. This role is accountable for leading night shift QC operations, ensuring accurate sample management, timely analytical testing, and sustained compliance with GMP, data...

Job Title Lead, Digital Quality and Compliance This position works out of our Plano, Texas location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. We are seeking a highly motivated and collaborative Digital Quality and Compliance Lead to drive digital transformation initiatives that improve quality intelligence, signal detection, regulatory intelligence, and proactive risk management across the product lifecycle. Individual contributor with comprehensive knowledge in automation and...

Job Title Quality Engineer – 2 nd Shift We are seeking a Quality Engineer for 2nd Shift in our Vascular division. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents What You’ll Work On Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of...

We anticipate the application window for this opening will close on - 13 Oct 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...