Quality & Regulatory Jobs in Pharma & Biotech

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...

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those who rely on our products. What You Will Achieve Candidate will be...

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. The Quality Manager is a hands-on role that requires aptitude, energy to build a QMS from the ground up....

The Associate Director, Clinical Supplies Quality, Global Development Quality provides quality oversight, disposition support, and strategic quality leadership for Clinical Supply Chain activities supporting clinical development programs across the company’s portfolio. The role is accountable for ensuring clinical supplies are available, fit for use, and compliant with applicable regulatory requirements. Key areas of responsibility include U.S. quality operations and disposition, global distribution planning and management, Medical Device/Combination Product supply activities, and acquisition integration. Primary Activities This position requires close, cross-functional collaboration with key stakeholder groups, including Global Clinical Supplies, Global Development Quality, Regulatory Affairs, Device Development & Technology, External Development...

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

The successful candidate will contribute to the advancement of our product pipeline by performing QA batch record review, label review and verifications, document archival of records, and other assigned tasks. You will also be exp ecte d to in dependently coordinate and manage timelines for batch record reviews. You will be expected to provide support for both the Santa Mo nica, CA and Tarzana, CA sites as needed. Responsibilities include, but are not limited to Reviews routine manufacturing batch documentation and quality control data for in-process and finished product to support disposition and lot closure. Review routine material release documentation...

At AstraZeneca Cell Therapy, we are building the capabilities required to deliver complex, personalized therapies through a highly coordinated, patient-centered operating model. As we strengthen our Vein-to-Vein Operations, we are increasing our focus on standardized execution, patient and product traceability, proactive exception management, operational performance, and quality. The Senior Specialist, Cell Therapy V2V Process Excellence & Quality Operations will support the implementation, standardization, and continuous improvement of scalable Vein-to-Vein processes across the patient and product journey. The role will translate approved operating models and process standards into practical workflows, controlled documentation, performance measures, and improvement initiatives that enable consistent, compliant,...

We anticipate the application window for this opening will close on - 12 Nov 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 - 12 Nov 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 supports the Surgical...

We anticipate the application window for this opening will close on - 13 Nov 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 The Cardiac Ablation...

We anticipate the application window for this opening will close on - 5 Nov 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,...

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 duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative...

We anticipate the application window for this opening will close on - 5 Nov 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...

Purpose The Director, Risk & Compliance Strategy plays a critical role in strengthening procurement processes through strategic risk management, compliance adherence, and comprehensive audit strategies. The Director, Risk & Compliance is responsible for ensuring the deployment of strategies within the Risk & Compliance teams in addition to leading and coaching a team, ensuring their professional development aligns with organizational goals. This role demands a candidate with a robust background in enterprise risk management, including areas like IT security, procurement, cybersecurity, business continuity, quality, supplier management, and / or legal. Responsibilities Lead the enterprise procurement risk, audit, and compliance strategy, translating...

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...

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...

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 Manager, EHSS and DEA Regulatory provides strategic and operational leadership for Environmental Health, Safety & Sustainability (EHSS), emergency preparedness,...

About This Role The Head of Corporate Quality is responsible for creating and managing the Global Biogen Quality Management System (QMS). The main areas of focus include Quality Systems, internal and external audits for cGMP compliance (including external vendors and CMOs), IT Quality, Technical Product Complaints, and Central Knowledge Management (including documentation). This role is central to Quality and PO&T, managing risk, compliance performance, staying compliant with regulatory changes, and seeking opportunities to gain efficiency and effectiveness in the administration of PO&T’s cGMP systems. Additionally, the role is accountable for preparing semi-annual executive-level updates on the state of Biogen’s QMS...

Role Overview The Associate Director is responsible for the review and approval of all US promotional materials and serving as the promotional regulatory expert with legal, medical and commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, our Company's policies, and support business objectives. Serve as the liaison and manage correspondence with FDA’s promotional review divisions OPDP/APLB, including complex regulatory questions and submissions for advisory comment. Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk. Provide regulatory consultation in the development and implementation of US...

Role Overview The Sr. Specialist, Regulatory Affairs – Power Platform Solutions Specialist is a hands-on application support and configuration role supporting our system, the business-built country regulatory requirements management platform within Global Regulatory Affairs and Clinical Safety. Our system uses Microsoft Power Platform, including Dataverse, Power Apps, Power Automate, and Power BI, with Microsoft Teams and SharePoint supporting communications and support activities. As a member of the Platform Team, the incumbent communicates directly with users who submit tickets to understand their issues and requests, documents basic business requirements, and helps deliver approved application improvements. The role configures Power Apps and...

Build our future together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Device Regulatory Affairs Lead, Diagnostics Focus to join our Regulatory Affairs team, supporting our device and diagnostics programs in a remote work model. In this role, you will lead regulatory strategies for Companion Diagnostics, In Vitro Diagnostics, and Digital Health Technology while collaborating with cross-functional stakeholders and external partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & where Location Remote Monday -...

We anticipate the application window for this opening will close on - 21 Nov 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Neurovascular business within Medtronic develops technologies...

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

Depuy Synthes is the largest, most innovative, and comprehensive orthopaedic business in the world. Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your...

This is what you will do The Patient Experience Team (PEX) fuels Alexion AstraZeneca Rare Disease ’s corporate priorities by ensuring the patient voice guides every stage of our work. Increasingly global regulators, and decision makers such as HTA bodies and payors recognize the value of lived patient experience data (PED) to inform therapeutic development regulatory decision-making in line with guidance including patient-focused drug development , while supporting coverage and access decisions that can impro ve real-world outcomes . The Patient Experience and Regulatory Engagement role serves as a strategic bridge between Global Medical Affairs, R&D, Global Marketing & Market...

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. What You Will Achieve In this role, you will Lead the completion of assigned complex projects, meet agreed targets and develop plans for work activities on projects within a team. Provide high level data analysis support for Quality Investigations or troubleshooting. Comprehensive understanding of {Current}...

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’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...

Director, SAP Role Security & Compliance The Director, SAP Role Security & Compliance leads the SAP-specific capabilities required to deliver and operate secure, compliant, and well-tested ERP solutions. Reporting within the SAP organization, this role owns execution across SAP security, testing, and compliance while partnering with enterprise control functions on policies, standards, and oversight. This role is an onsite position located at our Foster City, CA headquarters or at our Raleigh, NC office. We do offer a hybrid environment with 3 days in the office and 2 days optional work from home (Monday & Friday). Key Responsibilities Strategy &...

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. PRINCIPAL OBJECTIVE OF THE POSITION The Senior Specialist, Validation Engineer II supports the successful implementation of manufacturing, and laboratory equipment...

The Lead Quality Dossier Program Auditor role supports the Quality Dossier Program audit process by planning and conducting audits required by the Quality Dossier Program. This includes effectively communicating and interacting with business partners, e.g., Medical Writing; Regulatory Affairs; Development Sciences, etc., during the audit process and managing other aspects of the audit program, including maintaining the audit schedule, reporting metrics, presenting to Senior Leadership as needed. Responsibilities Plan and conduct audits required by the Quality Dossier Program. Audits may be of clinical documents, pre-clinical documents, CMC documents, etc. Perform peer reviews of document audits. Review audit responses for...

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

About This Role The Sr. Associate II, Compliance plays a critical leadership role in ensuring the RTP Drug Substance Manufacturing site maintains a strong state of compliance and inspection readiness. This position partners closely with Site Leadership and Quality teams to oversee inspection management, data integrity, and quality systems, while driving continuous improvement across local and global processes. This role is instrumental in ensuring adherence to regulatory requirements and strengthening a culture of quality and compliance across the organization. What You’ll Do Lead site compliance and inspection management activities, including planning, execution, and regulatory response coordination Ensure the site remains...

Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, plays a direct role in treating patients with cancer, respiratory diseases, and autoimmune conditions globally. At FMC, we are committed to delivering life-changing medicines while also creating a workplace where people feel valued and connected. From catered site events and friendly competitions to community outreach, environmental and wellness programs, and team-building activities, we make...

At Gilead, our pursuit of a healthier world for all people has led to a cure for hepatitis C, revolutionary advances in HIV treatment and prevention, and progress across viral and inflammatory diseases and certain cancers. We set bold ambitions in our fight against some of the world’s most devastating diseases. We are united by a shared commitment to solving complex public health challenges and improving the lives of patients for generations to come. Gilead is seeking an Associate Director, Regulatory Operations & Digital Enablement to advance operational effectiveness and digital enablement across CMC Regulatory Affairs. This role will lead...

ROLE SUMMARY The Director, Computer System Quality Lead provides strategic and subject-matter leadership for Computer System Assurance and the quality oversight of GMP/GDP computer systems across PGS sites and Digital organizations. The role establishes and advances consistent, risk-based assurance practices for enterprise Digital, artificial intelligence and federated solutions, ensuring systems remain appropriately controlled, monitored, compliant and inspection-ready throughout their life cycle. Serving as the Quality authority for the Digital process framework, the Director applies deep functional expertise and independent judgment to complex system risk assessments, classifications, assurance strategies and compliance matters. The role partners with Pfizer business Quality units to...

USE YOUR POWER FOR PURPOSE Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. WHAT YOU WILL ACHIEVE This role is a strategic pillar within Pfizer’s Medical Device and Combination Products (MDCP) Quality Operations global team. Serving as a key global quality partner, you will champion and govern development, sustaining, and post-market...

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our...

Use Your Power for Purpose The Principal Validation Engineer under Andover Site Technical Services (STS) is the principal owner of the Pfizer (PGS) Andover site validation program and master plan. The incumbent is responsible for delivering overall site validation program effectiveness and compliance in partnership with validation program owners across Andover site functions and the Pfizer network What You Will Achieve In this role, you will Establish and maintain overall Andover site validation philosophy and master plan in partnership with local validation program owners, technical subject matter experts, and relevant Pfizer global/network/site quality system principals applicable to biologics drug substance/drug...

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 Commercial Analytical Science (CAS) team within the Quality Control Strategy and Science (QCSAS) department is embedding AI into its...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer - Global Functions for the Innovative Medicine business with responsibilities for areas within the Global Commercial Strategy Organization (GCSO) and IM Business Development. Purpose The Senior Manager will serve as a trusted advisor to the business, providing practical, risk-informed guidance that enables compliant business performance, supports innovation and growth, and strengthens a culture of integrity, accountability, and responsible business outcomes. This role requires a combination of healthcare compliance expertise, strategic business partnership, strong execution, and global stakeholder influence. The Senior Manager, Health Care Compliance...

We anticipate the application window for this opening will close on - 7 Nov 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 - 14 Nov 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...

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

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

Will be an onsite position at our Irving, TX office. Associate Quality Engineer will provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality products to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. What You’ll Work On Responsible for following compliance from Corporate and Divisional Policies and procedures. Owns basic exception / CAPA activities with management oversight. Implements minor changes through change management system and may support major change implementation. Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation...

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission review of documentation for International geographies (primarily China) regulatory registration, ensuring products and procedures comply with regulations. Additionally, will support necessary regulatory activities required for product market entry. What You’ll Work On Assist in the preparation of regulatory applications to achieve departmental and organizational objectives, focused on China. Review applicability of medical device regulations to ensure submission requirements are current, up-to-date and are entered into regulatory...

Our Company's Animal Health Division offers veterinarians, farmers, pet owners and governments the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. Our company's Animal Health Division is committed to operating its business in a way that is best suited to meet the unprecedented demands faced today. Its strategic goal is to achieve sustained growth through the continued provision of integrated solutions with innovative animal health products and services that meet the evolving needs of our customers. Purpose of the role As Director ATS (Analytical Technical Solutions) US lead your role is integral to shape our manufacturing...

Material Compliance Manager What you will do Materials Compliance Manager who will be responsible for Material Approval and Compliance (MAC) that manages the review and approval process to ensure that only compliant messages are communicated to the public. This role will report to the Director or Executive Director of Material Compliance in Regulatory Affairs. The Materials Compliance Manager will manage the materials review process for assigned business units and/or products. The Manager will represent Material Compliance in process discussions with Sponsors and Reviewers and maintains integrity of neutrality while managing needs of all MAC stakeholders. The Manager contributes to...

J Sr Specialist QA - Compliance What you will do In this vital role, you will provide site-level leadership for inspection readiness across both manufacturing facilities, driving a sustained state of readiness for regulatory inspections, corporate and internal audits, and customer audits. You will lead the development and execution of readiness strategies, establish clear governance and accountability, and influence cross-functional partners to identify and address risks before they affect inspection outcomes. As a primary site coordinator, you will oversee inspection logistics including schedules, rooms, escorts, subject matter expert support, document retrieval, communications, and daily inspection management while adapting plans...

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...

Responsibilities for the position are as follows Lead and provide end-to-end accountability for one or more QC Technical Services functional areas QC Investigations (including Laboratory Investigation Reports [LIRs] and Nonconformance Reports [NCRs]); Trend Reports (including Quarterly Reports and Track & Trend); Shared Services (including sample management and laboratory services); QC IT Support; QC NPI; TMTs; TMVs; and QC Capital Projects, including equipment qualifications and new technology implementation. Establish priorities, objectives, governance, resource plans, performance indicators, and escalation pathways for assigned functional areas. Translate site, Quality, and business strategies into tactical deliverables that support compliant laboratory operations and continuity of supply....

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 Quality Engineering, Manager work closely with business leads and other IT partner functions to develop and maintain in-depth understanding of business needs and objectives in both business and technology realms. They also stay abreast of dynamics and evolutions in their business and technology areas of assignment to proactively recommend future solutions or other opportunities to the business. IT Quality Engineers support Validation of regulated systems implementations, audits, and inspections. Specific Responsibilities and Skills Oversee complex portfolio of systems and ensures validation activities adhere to quality standards and best practices. Manage an area of the overall IT Quality Engineering Program...

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...

Build our future together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking Director, Regulatory Affairs Advertising & Promotion Global to join our Regulatory Affairs team, supporting our global development and commercial business in a hybrid work model. In this role, you will lead advertising and promotion regulatory strategy, shape product messaging, and support compliant commercialization activities while collaborating with Commercial, Medical Affairs, Legal, and Regulatory stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & where Work...

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 Quality & Validation (Q&V) department is the Quality Unit that reviews and approves validation lifecycle documents, procedures, and technical reports related to (1) facilities, equipment, utilities, (2) cleaning, (3) processes, (4) analytical methods, (5) requalification, (6) sterilization, (7) transport, and (8) computer systems. Q&V provides leadership, direction, and oversight...

We are searching for the best talent for Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization located in Titusville, NJ; Raritan, NJ; Horsham, PA; Spring House, PA; Irvine, CA; or La Jolla, CA. This is a hybrid position where the successful candidate will be expected to report to one of the listed sites 3x/week. In R&D Quality, we continue to invest in our talent, diversity, and expertise, to make quality a business differentiator and competitive advantage – allowing our business partners to better deliver what really matters to customers and patients. QA delivers innovative risk-based audit and...

We anticipate the application window for this opening will close on - 9 Nov 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 Working closely with leaders across Quality, Engineering,...

We anticipate the application window for this opening will close on - 13 Nov 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 - 12 Nov 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Medtronic’s Advanced Energy Operating Unit develops technologies...

We anticipate the application window for this opening will close on - 12 Nov 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 Manager, Regulatory Affairs - Strategic Alliances...

We anticipate the application window for this opening will close on - 6 Nov 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...

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programs, pension plan membership, and shares and savings programme. We embrace modern work practices; our Performance with Choice programme offers a remote or hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company-wide benefits and life at GSK on our webpage Life at GSK | GSK Find out more about GSK and R&D Our approach to...

We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in New Brighton, MN. This new team member will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions as well as assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation, with a primary focus on post-market change...

This position works out of our Abbott Park (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 Quality Professional will analyze quality standards for components, materials, or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met. What You’ll Work On Design/Change Control - Participating in the development &...

This is not a remote opportunity Must be able to travel up towards 5% The Associate Customs Trade Compliance Analyst supports Abbott's import, export, and Foreign Trade Zone (FTZ) compliance programs by ensuring adherence to U.S. Customs regulations, FDA requirements, export controls, and corporate policies. The role analyzes trade and operational data, conducts compliance reviews and audits, maintains classification and country-of-origin records, and supports customs inquiries and corrective actions. Reviewing import, export, and FTZ transactions for regulatory compliance. Conducting audits, identifying compliance risks, and recommending corrective actions. Maintaining tariff classifications, country-of-origin determinations, valuation data, and trade records. Supporting customs activities...

As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory approval, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for clinical trial operations and product market entry. What You’ll Work On Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Reviews and provides input on device labeling. Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory...

Director, Global Regulatory Affairs – Cardiometabolic Disorders What you will do The Global Regulatory Affairs Director provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions—a rapidly evolving therapeutic area requiring sophisticated scientific, clinical, and regulatory assessment. You will be accountable for developing and executing global regulatory strategies, shaping cross-functional decision-making, and leading global interactions with Health Authorities and external partners. This role ensures regulatory strategies fully reflect the unique scientific, mechanistic, and clinical complexities of metabolic disorders. Key Responsibilities Regulatory Strategy & Scientific Leadership Develop and lead global regulatory strategy for obesity and metabolic disease...

Regulatory Policy and Intelligence Associate Director What you will do The Regulatory Policy and Intelligence team advances important policy issues, aligned with Amgen’s goals and priorities, by engaging externally with regulators, industry trade associations, consortia and other stakeholders, along with internal subject matter experts across Amgen. In this vital role, you will lead the development and articulation of Amgen's positions on regulatory policies that impact Amgen's business within a defined portfolio, exercising independent judgement and driving cross-functional alignment. You will report to the Amgen’s U.S. Lead for Regulatory Policy and Intelligence. Primary Responsibilities Foster U.S. trade association relationships and...

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 journey to...

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....

Johnson & Johnson is currently recruiting for an Analyst Quality Systems! This position will be located in Raritan, NJ and performed fully onsite Monday-Friday. 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...

Sr. Director, ERP GMP Quality Lead Role Overview The ERP GMP Quality Lead provides quality leadership and independent GMP oversight for the design, deployment, and operation of enterprise resource planning solutions supporting regulated business processes for the Quality Business Processes. This role ensures ERP processes and controls are fit for intended use, compliant, standardized where appropriate, and supported by proportionate risk-based assurance across sites, functions, regions, and integrated systems. The lead partners with Quality, Business, IT, Data, Security, and Validation stakeholders to enable compliant and sustainable transformation. The role covers GMP-relevant ERP capabilities including quality planning and inspection, batch disposition...

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. Responsible for the registration of new products/line extensions/claims. Supports commercial activities while ensuring regulatory compliance and provides product development teams with...

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 Manager, Environmental Health, Safety & Sustainability (EHSS) Environmental Compliance is responsible for leading the implementation, oversight, and continuous improvement of...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Bristol-Myers Squibb Company is hiring a(n) DCM Quality Management - SAP (in Princeton, NJ). Duties Translate business requirements into solutions using...

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

Senior Associate Quality Control What you will do In this vital role you will provide support for QC Centralized Raw Material Testing in the Wet Chemistry Laboratory at Amgen Rhode Island. The Sr. Associate Quality Control (QC) position will provide support for QC Centralized Raw Material Testing in the Wet Chemistry Laboratory (Monday – Friday 800 am – 430 pm) at Amgen Rhode Island. The Sr. Associate QC will be responsible for execution of routine tasks and testing including but not limited to time sensitive samples from Centralized Raw Material testing (compendial testing). Responsibilities Ensures that facilities, equipment, materials,...

Are you ready to be part of the future of healthcare? Can you think big, be bold, and harness the power of digital and AI to tackle one of the most stubborn problems in regulated software engineering — knowing, with confidence, that what you shipped works? Then Evinova, a health tech business part of the AstraZeneca Group, might be for you. We are building software that transforms clinical trials. Evinova delivers market-leading digital health solutions that are science-based, evidence-led, and human experience-driven. Quality is not a gate at the end of our process — it is embedded in everything we...

Associate Quality Specialist The Associate Quality Specialist is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday. What You’ll Work On Responsible for implementing and maintaining the effectiveness of the Quality System. Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation. Assist in determining quality attributes and requirements. may provide...

We are recruiting for a Regulatory Affairs Specialist II to join our team on-site in New Brighton, MN. As an individual contributor, the function of a Regulatory Affairs Specialist II is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide, with a strong focus on post-market change management. What You’ll Work On Analyzes the input of cumulative product changes to current...

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

This position works out of our Scarborough, ME location in the Infectious Disease , 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 Quality Engineer I role will be responsible for supporting product quality assurance activities, process improvement initiatives, quality system programs, qualification and validation activities, supplier quality management activities, and compliance with applicable FDA and ISO requirements. This position partners with Manufacturing, Operations, Engineering,...

Job Title Quality Assurance Supervisor I We are seeking a Quality Assurance Supervisor I for our Vascular division in Westford, MA. The Quality Assurance Supervisor I p rovides leadership to inspectors and technicians that support receiving, in-process and final inspection, tool inspection/qualifications and first article inspections. Oversees operational implementation of quality assurance strategies and regulations. Completes the assessment of potential risks, ensures compliance and gives recommendations to management. Supervises team to ensure quality control aspects of the process are met (laboratories studies, clinical research, testing, operations, raw materials, production, finished product or services). Facilitates audits and regulatory inspections. Liaises...

Job Title Validation Engineer This position works out of our Sturgis, MI location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. For over 70 years, Abbott’s Sturgis, Mich. , has been impacting its community while producing products that provide essential nutrition to millions of...

Job Title Associate Quality Engineer (second shift - 330pm to 200am) This position works out of our Westford, MA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. This is an onsite role. Schedule is Monday - Thursday, 10-hour shifts. 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 This position is responsible for...

Job Title Quality Assurance Manager Our location in Temecula, CA, currently has an opportunity for a Manager, Quality Assurance. THIS IS AN ONSITE ROLE. WHAT YOU'LL DO Leads the team of Quality engineers to support manufacturing. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements. Main Responsibilities Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources. Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting...

Quality Engineer This position works out of our Sturgis, MI location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. For over 70 years, Abbott’s Sturgis, Mich. , has been impacting its community while producing products that provide essential nutrition to millions of families around...

You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. The Quality Specialist supports Quality Management System (QMS) execution and quality operations within the Woolwich Distribution Center, ensuring compliance with regulatory requirements, internal quality standards, and Medtronic quality system procedures. This role partners closely with Distribution Operations, Supply Chain, Engineering, Regulatory Affairs, and Quality leadership to support product flow, nonconforming product management, audit readiness, process improvement, and continuous quality initiatives that enable safe and compliant distribution activities. This position is based in Swedesboro, New Jersey and is fully onsite. Approximately 5% travel is required, primarily...

We anticipate the application window for this opening will close on - 4 Nov 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...

We anticipate the application window for this opening will close on - 13 Nov 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Medtronic Global Operations and Supply Chain...

We anticipate the application window for this opening will close on - 11 Nov 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,...

This position works out of our La Jolla location in the Cancer Diagnostics Division. The Bioinformatics Quality Engineer 1 is responsible for ensuring the quality of the medical device software for IVD, IUO and LDT products. This entails executing verification activities to ensure quality and compliance for products. The Bioinformatics Quality Engineer 1 will be involved in testing, verification, and validation of the bioinformatics pipelines in all phases of system development. Depending on the area of focus, the position is responsible for ensuring the creation and execution of verification protocols. Working in a team setting, this role will contribute to...

Purpose Provides leadership and direction in software validation activities including reviewing software requirement documents; writing and reviewing validation documents (test plans/strategy and detailed test cases/instructions); executing and reviewing validation test cases; updating departmental procedures and templates. Responsibilities This position will be responsible to provide validation support for OT projects, primarily DeltaV and/or Allen-Bradley PLCs, and ongoing manufacturing automation validation support activities. Support Factory Acceptance Testing in conjunction with Project Engineers to confirm unit is acceptable. The APC Validation Engineer is responsible for ensuring software quality assurance is achieved during OT projects while meeting project objectives and deliverables. The position is...

Purpose The Senior Manager, Quality provides leadership and direction for the Quality function within Operations. This role is responsible for the effective implementation of AbbVie quality systems within their area of responsibility, including quality oversight of AbbVie-owned warehouses (AP5, AP15, and AP32), the 3PL network, transportation service providers, and quality-relevant suppliers supporting distribution and logistics. Accountabilities also encompass training, regulatory compliance, quality planning, and strategic initiatives. The Senior Manager, Quality leads a team of Quality professionals responsible for compliance and quality oversight across AbbVie-owned warehouses, service providers, and strategic initiatives. This position manages a budget and is accountable for maintaining...

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

Johnson & Johnson is hiring for a Principal Quality Engineer (Design Assurance) to support the Shockwave Reducer business located in New Brighton, MN. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Cardiovascular...

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...

Johnson & Johnson is currently recruiting for a Quality Control Analyst, CAR-T Critical Reagents! This position will be located in Raritan, NJ. Johnson & Johnson Innovative Medicine and Legend Biotech

We are searching for the best talent for a Senior Robotics Verification & Validation (V&V) Engineering Manager to join our Orthopaedics team. This is a hybrid role located in Boston, MA . Purpose The Senior Robotics Verification & Validation (V&V) Engineering Manager is responsible for ensuring that robotic products meet all defined system and subsystem level requirements and are safe, effective, and compliant for their intended clinical use. This role plays a critical part in supporting regulatory submissions and product releases by planning, executing, and documenting comprehensive V&V activities in accordance with FDA regulations, ISO 13485, IEC standards, and other...

We are searching for the best talent for a Sr. Executive Administrative Assistant. This hybrid role will be in Raritan, NJ, Horsham, PA and Titusville, NJ. The requirement for this position is to work in the office 3-4 days per week and work from home 1-2 days per week . 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...

DePuy Synthes is recruiting for a Technology Manager, Quality Systems, BA , located in Raynham, MA or West Chester, PA or New Brunswick, NJ or Palm Beach Gardens, FL or Warsaw, IN The Technology Manager, Quality Systems, BA leads the business analysis capability supporting DePuy Synthes enterprise quality systems within the Supply Chain Technology function, Quality sub-function. This role manages a team of individual contributors and/or supervisors and is accountable for effective performance management, capability building, and career development. The Manager develops tactical and operational plans for quality systems requirements delivery, serving as the primary bridge between Quality, Regulatory, and...

Key Responsibilities QC Strategy & Operations Lead and oversee all Quality Control functions at the site, including analytical, microbiology, raw materials, in-process, drug substance, drug product, and stability programs across small molecule and biologics platforms Define and execute the site QC strategy, aligned with global quality and business objectives Ensure effective support of commercial manufacturing, PPQ, technical transfers, and new product introduction Ensure QC operations meet global GMP requirements and maintain a continuous state of inspection readiness Represent QC during regulatory inspections and audits, ensuring strong compliance and data integrity standards Technical Capability Strengthening & People Leadership Build and strengthen...

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 GRS-CMC Director is responsible for overseeing management of multiple development and life-cycle management projects of varying priorities and complexities. Represent...

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 BMS Global Regulatory Sciences Summer Intern Program is your chance to step inside one of the world's leading biopharmaceutical...

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 Patient Safety Intern will gain hands-on experience across multiple areas of pharmacovigilance and drug safety while supporting strategic initiatives that...

Quality Assurance Senior Manager What you will do This QA Sr. Manager role will be responsible for the quality oversight of primary component suppliers. This person is an integral member of the Amgen cross-functional supplier team(s) that includes, but is not limited to, business operations, process development, supply chain and combination product quality. Key Responsibilities Act as the quality lead for supplier relationships, from onboarding through disengagement, ensuring performance through robust proactive monitoring, technical site visits, and continuous improvement. Perform proactive quality management of suppliers, ensuring compliance with global regulatory standards, including but not limited to GDP, GMP, ISO,...

Senior Associate Quality Control What you will do In this vital role, under minimal supervision, you will be responsible for activities including Raw Material testing using sophisticated instrumentation, such as HPLC, GC and GC-MS, sample/data management and equipment/instrumentation operation and maintenance in a highly dynamic, team environment. Responsibilities include Perform testing methods including HPLC, GC and GC-MS Perform testing and data analysis for compendia, non-compendia methods, and routine laboratory procedures Perform routine and non-routine evaluations and data review Generate accurate and concise laboratory documentation using electronic systems and notebooks Operate and maintain specialized laboratory equipment and instrumentation Participate in...

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

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

Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines? At AstraZeneca , we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life...

Associate Director – Validation Tarzana, California Job Summary The Associate Director – Validation is responsible for leading and managing the validation program within the Facilities and Engineering department supporting validation needs site wide, including Site and Project Validation Master Plans, facility and equipment commissioning / qualification / validation (CQV) processes, equipment life cycle validated status assessments, validation documentation packages, and compliance with cGMP regulations within a pharmaceutical organization. This role involves providing expert technical guidance, overseeing complex projects, and ensuring that all systems and processes meet regulatory requirements and support operational efficiency. Key Responsibilities Validation Program Leadership and Oversight Establish...

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

Location San Diego, CA. Not remote. We are hiring a Senior Staff AI Engineer to set the technical direction for quality engineering across Illumina's enterprise platforms, with AI agents doing a growing share of the testing work. You will be the most senior individual contributor in QA you design the test architecture, lead our Tricentis platform, and make agentic testing safe enough for regulated, GxP-relevant systems. Technical leadership of 10-20 QA and automation engineers across vendors and teams. The role sits in Enterprise AI and partners with Data Engineering, application teams (SAP, Salesforce, ServiceNow, Workday, M365) and Quality &...

Role Overview The Associate Director of Regulatory Operations Content Management will serve as a strategic business partner and subject matter expert (SME) supporting the advancement of Regulatory Operations capabilities across submission planning, content management, and registration management within a dynamic digital and AI-enabled pharmaceutical environment. This role will partner closely with Regulatory Affairs, CMC, Quality, IT, Supply Chain, and global business stakeholders to support operational strategy, digital transformation, process optimization, and scalable regulatory execution across multiple therapeutic modalities and organizational functions within Reg CMC. The ideal candidate combines strong CMC operational expertise with sound business judgment, effective communication skills, and...

Our Quality organization ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed in alignment with our incredibly high standards of quality while meeting all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. The Associate Director within Quality is responsible for providing quality direction and oversight to a Drug Substance capital project according to our quality systems, including Training, Documentation, Change Control, Inspection Management, Quality...

This position supports our Madison, WI locations within the Cancer Diagnostics business. As an Associate Quality Assurance Engineer, you’ll partner with Operations to help ensure manufacturing processes, materials, and products meet quality and regulatory requirements. You’ll support validation and qualification activities, investigate quality issues, review production documentation, and assess materials for commercial release while contributing to process improvement and operational excellence. What You’ll Work On Partner with Operations as a Quality representative to review production records, executed test methods, and material disposition decisions before commercial distribution. Review process and test method validation, equipment and facility qualification documentation, and calibration records;...

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

We anticipate the application window for this opening will close on - 6 Nov 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life LOCATION O nsite at a US-based Medtronic...

We anticipate the application window for this opening will close on - 7 Nov 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 Cranial & Spinal Technologies (CST) develops therapies,...

Participates in clinical and nonclinical regulatory strategic discussions, supports multiple products’ clinical trial and registration and activities. Responsible for cross-functional execution of regulatory activities at the team level to support assigned programs and markets. Supports the implementation of regulatory strategy for assigned markets & provides regulatory support for the registration/post-licensing activities of medicinal products. Maintains and develops knowledge of assigned market regulatory procedures. Builds/maintains relationships within GRA & other stakeholders to support effective communication & efficient implementation of regulatory activities for assigned markets & activities. The Opportunity to Make a Difference Acts as the regulatory affairs clinical lead for clinical...

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

We are searching for an HR Leader, Global Quality & Regulatory Affairs to be located in Warsaw, IN, Raynham MA, West Chester, PA, Palm Beach Gardens, FL, or Raritan, NJ. The HR Leader, Global Quality & Regulatory Affairs is responsible for setting and leading the people strategy, design, governance, and delivery of HR programs supporting this global organization. Reporting to the Head of HR for Global Quality, Regulatory & Patient Safety, this role serves as a strategic partner to the Global Quality team to drive talent outcomes aligned to business priorities. The role provides leadership across talent strategy, organization effectiveness,...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer to be located in Jacksonville, FL; Irvine, CA; Danvers, MA; Raritan, NJ; or New Brunswick, NJ. Purpose This role provides strategic leadership for healthcare compliance within a highly dynamic and regulated environment while enabling compliant and sustainable growth across Johnson & Johnson Vision’ businesses. The Senior Manager, HCCO will be primarily responsible for the implementation and support of programs designed to ensure the Company meets statutory and regulatory requirements relating to health care fraud and abuse; as well as advertising and promotion laws governing the...

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...

Key Responsibilities GMP Operations Quality Oversight · Provide Quality Assurance oversight of GMP Manufacturing and QC testing operations through the product lifecycle from master cell bank to drug product. · Provide Quality Assurance strategy and oversight of external QC laboratories, ensuring method lifecycle activities (qualification, verification, and validation) are executed in compliance with cGMP, ICH, and internal quality standards, with appropriate review and approval of protocols, reports, and methods. · Review and approve laboratory investigations (e.g., OOS/OOT/deviations) conducted by contract partners, ensuring thorough root cause analysis, robust corrective and preventive actions (CAPA), and aligned decision-making impacting product quality and disposition....

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...

The Director, Quality Risk Management (QRM) is an enterprise Quality leader responsible for defining, governing, and advancing the global strategy for Quality Risk Management across the organization. This role actively supports the Executive Director of Risk and Proactive Quality and has direct leadership accountability for the Quality Risk Management process across PDM. This leader provides strategic direction and oversight to ensure that QRM principles, risk‑based thinking and proactive quality approaches are deeply embedded across the Pharmaceutical Quality System (PQS) and operations. The role is accountable for designing, implementing, and sustaining compliant, scalable, and efficient global processes that enable early risk...

The Senior Manager, Design Quality is a hands-on Quality leader who combines supervisory responsibilities with direct Design Quality support for product-development programs. The role leads and develops a team of Design Quality professionals while partnering with Product Development to establish fit-for-purpose Quality strategies, identify and address risk early, and ensure development decisions are supported by appropriate technical evidence and rigor. Responsibilities The Senior Manager is accountable for effective Design Quality execution across assigned programs, including product risk management, design controls, verification and validation, design transfer, process validation, change management, and resolution of product quality issues. The role provides direct technical...

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 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...

Quality Compliance Program Manager This position works out of our Plymouth, MN location in the Electrophysiology division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies, allowing people to restore their health and get on with their lives. As the Quality Compliance Program Manager , you will partner with leaders across manufacturing, quality, regulatory, and commercial functions to drive key compliance initiatives, strengthen audit readiness, manage critical quality programs, and influence the future of our quality culture. The role also includes leadership of audit readiness, field actions, standards and regulation change management, certificate management, and...

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

We anticipate the application window for this opening will close on - 31 Dec 2026 Position Principal Quality Engineer for Medtronic, Inc. in Grand Rapids, MI. Responsible for products in the form of finished medical devices by supporting manufacturing operations and evaluating compliance of materials and processes with product specifications, regulatory requirements, and customer requirements. Coordinate Quality Engineering for medical device components, ensuring that all finished good and processes meet specifications. Leverage Good Manufacturing Practices (GMP) standards, navigate government and medical device regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, EU Medical Device Regulation...

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

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. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives. Main Responsibilities Promoting a culture of excellence and ensuring full implementation and sustainability of SMS 2.0...

Quality Control Microbiology Specialist Job Purpose The QC Specialist supports Quality Control laboratory operations by providing technical, documentation, investigation, and project support to ensure compliant, efficient, and reliable laboratory performance. This role writes, updates, and reviews laboratory procedures and technical documents; leads quality investigations and corrective/preventive actions; supports Quality Operations and GMP performance initiatives; drives continuous improvement and problem-solving activities; and represents the QC team on site-based projects, shutdowns, maintenance activities, and other non-routine work. Key Responsibilities Writes, updates, reviews, and maintains Laboratory Standard Operating Procedures, Analytical Methods, Specifications, and related controlled documents in alignment with current Good Manufacturing Practice...

The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

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...

Build our future together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director to join our Patient Safety team. The Global Patient Safety (GPS) Lead role (Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s)/asset(s) assigned within a given therapeutic area (TA), and is the GPS representative on the cross functional strategic program team (SPT) for the compound. The GPS Lead leads the safety strategy and ensures the optimal support from within GPS and works collaboratively with stakeholders...

The team vision is to become catalysts for providing risk based, predictive & objective assurance, insight, support, intelligence & The team vision is to become catalysts for positive change by identifying the unseen, providing risk based, predictive & objective assurance, insight, support, intelligence & advocacy. The mission is to foster best in class performance by leveraging data, technology, and diverse talents to secure product launches and support compliance through quality audits, regulatory inspections, regulatory surveillance and advocacy. Core values are integrity, collaboration, innovation and expertise. The team is comprised of ~40 people in 7 countries in USA, Euro Scope Includes...

The Associate Director, CMC Regulatory Affairs – Combination Products and Device is responsible for defining and advancing global CMC regulatory strategy for products, platforms, or major workstreams involving devices and combination products. This role ensures that regulatory strategy is integrated into development and lifecycle planning and that submissions are executed in a manner that supports approvability, business objectives, and continuity of supply. The Associate Director acts as a strategic partner across Pharmaceutical Development & Manufacturing (PDM) and cross-functional teams by translating complex technical, development, and regulatory considerations into clear regulatory pathways, risk-based recommendations, and executable plans. KEY RESPONSIBILITIES Define and...

Johnson & Johnson is currently seeking a Manager, Quality Clinical Risk Management to join our R&D Quality CRM team located at a J&J office in Spring House, PA; Titusville, NJ; Raritan, NJ; Horsham, PA High Wycombe, UK Beerse, Belgium; Basel, Switzerland, and Madrid, Spain. 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...

We are searching for the best talent for Manager, Data Quality 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 The Manager, Data Quality is accountable for improving the integrity of data across the One Data Platform (ODP). The role leads data quality operations, business-rule validation, data...

DePuy Synthes is recruiting for a Sr. Director, Regulatory Law, Orthopedics located in Raynham, MA, New Brunswick, New Jersey, West Chester, Pennsylvania. Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed sometime in 2027, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an...

The Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages the interactions with Health Authorities for CMC topics. This role also provides regulatory guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial products. This role may supervise other regulatory staff. Key Duties and Responsibilities Leads the preparation and review of CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies Develops global CMC...

Reports to Regulatory Operations (RegOps) Director in OPAR. The RegOps Associate Director is responsible for the review, approval, and oversight of regulatory submissions to the promotional review divisions of FDA (OPDP/APLB) for all U.S. products. Ensures regulatory submissions are aligned with FDA regulations and our Company standards. Functions as a point of contact for operational activities and coordinates with other Regulatory Affairs teams, including Publishing, Information Management, Data Sciences, and Regulatory Affairs Functions. Develops analytics, reports, and dashboards; leverages predictive modeling to identify trends and insights; and prepares quarterly metrics to track operational performance. Provides direction and performance management for...

Build our future together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Manager to join our Regulatory Affairs Advertising and Promotion team. The Associate Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). Provides regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs,...

Build our future together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager to join our Regulatory Affairs Advertising and Promotion team. This position requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). They will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs, Advertising and Promotion Director....

Build our future together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Regulatory Affairs Advertising and Promotion team. In this role, you will apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). This individual will provides regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs, Advertising and Promotion Director. The Manager...

Envision spending 6 months working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie AbbVie Co-Ops. The Quality Assurance Validation department is responsible for plant validation including validated system (Equipment/Process), risk/design and change control compliance. Our team ensures alignment with Global Quality Systems for validation and related functions, e.g. engineering, risk management. Key responsibilities include The Validation Engineering Co-Op will support the planning and execution of tasks reporting into the QA Validation department. This role will support various areas of manufacturing...

Envision spending 6 months working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie AbbVie Co-Ops. The Quality Assurance Validation department is responsible for plant validation including validated system (Equipment/Process), risk/design and change control compliance. Our team ensures alignment with Global Quality Systems for validation and related functions, e.g. engineering, risk management. Key responsibilities include The Validation Engineering Co-Op will support the planning and execution of tasks reporting into the QA Validation department. This role will support various areas of manufacturing...

At Abbott Cancer Diagnostics, we are cancer fighters. We are united by our mission to change lives by providing earlier, smarter answers. Through advances in cancer detection and treatment guidance, we will help eradicate the disease and the suffering it causes. This Engineer I, Quality role will be involved in all phases of system development including requirements, analysis, design, testing, and support. The ideal candidate must demonstrate the ability to understand system architecture, design, implementation and possess the ability to succinctly develop the testing strategy to deliver high-quality results in a time-sensitive environment. Location Onsite in San Diego, CA or...

This Associate Director, Regulatory Affairs will work on-site at our Westford, MA location in the Vascular Division. As a manager, the function of an Associate Director, Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual will develop and supervise regulatory professionals. The individual has department level influence and is generally recognized as an expert resource both within Abbott and externally. The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management...

This Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re 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. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment. In this role, you will combine knowledge of scientific, regulatory, and business issues to enable products...

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

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

The Site Director, Development Quality is a senior leadership role with a significant opportunity to influence how Quality enables the delivery of our exciting development portfolio. At its heart, the role is about protecting patients, ensuring GMP standards are met at the site while creating an environment in which quality enables development teams to move with pace, confidence and appropriate risk management. The Site Director provides Quality leadership at the site and contributes to the strategic direction of Development Quality globally. As a Quality leader, the role partners with leaders across Development and Supply Chain globally, helping teams build quality...

We anticipate the application window for this opening will close on - 5 Nov 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 Electro Physiology Technologies (EPT) business unit...

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 QC Specialist III at Gilead, you will support Quality Control laboratory operations through the administration, enhancement, integration, and continuous improvement...

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

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 Manager Regulatory Sciences Innovative Medicines is accountable for the local regulatory oversight of the assigned BMS products in...

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

The Manager Regulatory Affairs, Global Regulatory 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. This individual assists Regulatory Staff by identifying and gathering 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 product(s) within a Therapeutic Area and supports the Manager (Senior Manager, Associate Director, Director (Global Regulatory Lead (GRL), in the...

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

POSITION SUMMARY The CQV Engineeris responsible for the service and support of laboratory equipment and instrumentation utilized in the Operations laboratory. The scope of support includes installation, calibration, maintenance, and repair of both simple (e.g., plate sealers) and complex (e.g., liquid handling robotics) instrumentation in the laboratory. The Instrument Service Engineer will be the primary point of contact for production lab personnel when equipment and instruments are not operating or not meeting operational specifications. PRIMARY RESPONSIBILITIES Provides Level 2 support for all laboratory equipment, troubleshooting hardware and software with some support from Level 3, Automation, and vendor. ...

About This Role The Sr. Manager, Global Regulatory Affairs (GRA) supports the regulatory strategy and execution for assigned programs, working closely with the Global Regulatory Lead (GRL) and cross-functional teams. This role contributes to the development and implementation of regulatory submissions across multiple regions, ensuring alignment with global regulatory requirements and timelines. The Manager also serves as a key point of contact for regulatory operations and external partners (e.g., CROs), and provides backup support for regulatory activities within the team. What You'll Do Collaborate with the Global Regulatory Lead to support regulatory strategy and execution for assigned programs. Participate in...

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

The Senior Quality Engineer provides technical quality leadership for computerized systems, equipment, and digital solutions used within a regulated environment. This role is responsible for developing and executing Computerized System Validation (CSV) strategies, applying risk-based approaches to qualification and validation, providing quality guidance with change management, and ensuring systems and processes maintain appropriate data integrity throughout their lifecycle. The Senior Quality Systems Engineer partners with Quality, Manufacturing, Engineering, IT, Automation, system owners, and business process owners to ensure that systems are fit for intended use, appropriately controlled, and maintained in a validated state. The position serves as a subject matter...

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. Summary This position is critical to maintaining quality oversight and ensuring GMP compliance in day-to-day manufacturing operations. The Senior Field QA...

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 Sr. QA Specialist, you will hold a key role accountable for delivering Quality Assurance objectives supporting the Foster City Manufacturing...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As the Sr. Manager, Quality Assurance, you will hold a key role accountable for strategizing and delivering Quality Assurance objectives supporting the...

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US. In this role, you will provide regulatory input...

We anticipate the application window for this opening will close on - 4 Nov 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...