Quality & Regulatory Jobs in Pharma & Biotech

Position We are seeking an experienced Senior Director, Regulatory Affairs, to lead our regulatory strategy and compliance efforts. In this critical role, you will be responsible for ensuring that our biotechnological innovations align with all relevant regulations and standards. You will collaborate with cross-functional teams to guide product development and market entry strategies while maintaining a steadfast commitment to regulatory integrity and transparency. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical...

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

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

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

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

We anticipate the application window for this opening will close on - 22 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life As a Quality Engineer I at...

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

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

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

The Director Supplier Quality leads strategy, management and support for global supplier quality associated with the division. Areas include suppliers (parts and services), Third Party Manufacturers (TPM), and Original Equipment Manufacturers (OEM), service providers and consultants. Establishes quality systems and plans for supplier controls to assure design, development and manufacture of the highest quality products to exceed customer requirements. Interfaces with outside regulatory agencies. What You’ll Work On Champions quality and compliance through awareness of requirements, trends and other external influencing factors especially in the area of supplier management. Builds strategic partnerships with internal and external stakeholders to further departmental...

Job Title Quality Technician II Divisional Information In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. This position works out of our Avon, Indiana location in the Abbott’s Electrophysiology (EP) business. MAIN PURPOSE OF THE ROLE Provides independent evaluation of materials, components, and products per specific instructions, and work process within the quality system. Quality and production support resource to ensure compliance with policies and procedures within an atmosphere of error prevention and continual improvement. MAIN RESPONSIBILITIES...

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

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

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

Johnson & Johnson is recruiting for a Sr. Engineer, Facilities Management (FM) Risk, Quality and Compliance - Americas , located in either Jacksonville, FL; New Brunswick, NJ; Guaynabo, Puerto Rico or Irvine, CA. At Engineering & Property Services (E&PS) we take care of all J&J buildings around the world providing end-to-end services from Real Estate, Engineering & Strategic Project Delivery to Facilities Management. We have a profound influence on the entire J&J Enterprise, providing innovative workplaces where our employees can collaborate and grow, and delivering flexible site solutions which enable our business to best serve our important customers and patients....

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

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a “ Principal Engineer, Vendor Compliance & Asset Performance” to join our team in Raritan, NJ. Summary The Principal Engineer, Asset Management & Vendor Compliance Strategy, provides technical leadership for the...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer within North America MedTech. Purpose This role will support the Cardiovascular business by serving as a strategic advisor and trusted business partner on healthcare compliance matters. The successful candidate will partner closely with commercial, medical, and functional leaders to enable compliant business growth while maintaining the highest standards of integrity and corporate responsibility. The Senior Manager, Health Care Compliance Officer will provide oversight and execution of key elements of the Health Care Compliance (HCC) Program and ensure the integration of healthcare compliance principles into business...

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

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Design Quality Engineer I position. This role will support the Design Quality Engineering Group for the Trauma, Extremities, Craniomaxillofacial (CMF), and Animal Health businesses with the objective of launching and sustaining orthopaedic implants and associated instrumentation. This position contributes directly to product development, innovation, and lifecycle support by applying technical knowledge to ensure product...

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

Manages systems and processes to conduct effective Supplier Performance Monitoring (SPM) and Management across the organization. Supports day-to-day direction and improvement of the Source Quality organization's quality metrics systems. Ensures that processes, products, and services comply with established company and regulatory standards and partners with cross-functional departments in implementing quality procedures. Identifies ongoing quality and/or service issues and develops corrective and preventative action plans in response. Directs workflow to implement strategies designed to ensure Quality Systems are in line with internal best practices and in compliance with the organization’s Quality Assurance (QA) standards, international standards, and government regulations. Coordinates assignments...

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

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

Head, Regulatory Affairs, Joints, Digital and Power Tools Location Warsaw, Indiana; Raynham, MA; Palm Beach Gardens, FL; West Chester, PA; Leeds, UK; Cork, Ireland; or Zuchwil, Switzerland DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative, and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services, and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. As the leading Orthopedic company, we are committed to a world where patients have access to care that is personalized and connected....

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

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

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

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

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

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

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

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

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

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

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

The Quality Engineer is responsible for providing quality assurance support for some or all of the following manufacturing processes pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations. Responsibilities Assist with proper integration and support of quality regulations drug, biologics, device and/or combination products. Assist project teams in planning, preparation, review and approval of quality...

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

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

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

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

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

Senior Specialist Quality Assurance At Molecular Diagnostics, we realize the potential of personalized care as the laboratory’s most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics. The Senior Specialist, Quality Assurance role is part of our Molecular Diagnostics Business Unit and is based at either our Des Plaines, IL or Lake Forest, IL location. This role will conduct quality-related activities in the area of Complaint Handling to deliver consistent, high-quality documents, services, products, and processes that add value...

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

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

We are searching for the best talent for Quality Engineer to join our DePuy Synthes Quality organization located in Palm Beach Gardens, FL. The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. Our rapidly growing Velys Enabling Tech Operation is in need of a Quality Engineer who provides overall quality assurance leadership...

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

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

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 Sr. Manager, Corporate Quality – GCP, will provide program-level quality oversight and strategic support across Sarepta’s Clinical Development and Real-World Evidence portfolio. This role serves as a key Subject Matter Expert in Good Clinical Practice (GCP) compliance, ensuring that all clinical trial activities meet FDA regulations, ICH guidelines, and applicable international standards. As a core member of the Clinical Trial Team, the Sr. Manager will foster collaboration and deliver proactive QA guidance throughout the trial lifecycle. Responsibilities may include integration of acquired clinical programs into existing quality frameworks, vendor risk assessment and qualification, coordination and execution of investigator site...

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device 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 demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business...

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device 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 demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business...

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device 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 demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at 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,...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for an Associate Director, Regulatory Affairs, North American Regional Leader (NARL) to be located in Spring House, PA or Raritan, NJ. Purpose The Associate Director, Regulatory Affairs, North American Regional Leader ,...

Johnson & Johnson MedTech is currently seeking a Sr Program Lead, Regulatory Affairs to join our team located in Irvine, CA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at JOB SUMMARY Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. DUTIES AND RESPONSIBILITIES Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and...

Johnson & Johnson MedTech is currently seeking a Sr Program Lead, Regulatory Affairs to join our team located in Plymouth, MN. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at JOB SUMMARY Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. DUTIES AND RESPONSIBILITIES Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and...

Johnson & Johnson is hiring for a Sr. Clinical Quality Auditor– Shockwave Medical to join our team. This role is fully remote in the United States. 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...

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

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

The Director, CMC Regulatory Affairs – Combination Products and Device is responsible for setting and leading global CMC regulatory strategy for complex, high-impact device and combination product portfolios, programs, or regulatory domains. This role serves as a strategic thought partner in strategy and execution, to shape development and lifecycle strategy, anticipate regulatory risk, and enable successful global registration and lifecycle management. The Director operates at a strategic level across PDM, Global Regulatory Affairs, Quality, and other cross-functional functions, guiding decisions where regulatory pathways may be complex, evolving, or without clear precedent, while ensuring alignment with business priorities and long-term capability...

The Senior Manager, CMC Regulatory Affairs – Combination Products and Device is responsible for supporting CMC regulatory activities for development or lifecycle programs involving devices and combination products. This role supports the development and implementation of global regulatory strategy and is accountable for execution of high-quality regulatory submissions and lifecycle activities that support clinical development, product registration, and continued market supply. The Senior Manager partners closely with the Pharmaceutical Development & Manufacturing (PDM) team to ensure global regulatory requirements are incorporated into program planning and execution. KEY RESPONSIBILITIES Contribute to the development and implementation of global CMC regulatory strategies for...

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....

Employer Bristol-Myers Squibb Company Senior Engineer, IT Laboratory & Quality Systems, Devens Biologics Digital Plant Location 38 Jackson Road, Devens, MA 01434 Wage Range$126,859.00 - $133,630.00 Bristol-Myers Squibb Company is hiring a(n) Senior Engineer, IT Laboratory & Quality Systems, Devens Biologics Digital Plant (in Devens, MA). Duties Ensure secure administration of documentation, processes of benchtop equipment, lab, and quality systems. Provide end-to-end management within BMS systems to support changes, incidents, problems, and asset management and ensure completion within defined timeframes. Conduct assessment of system reliability. Act as plant subject matter expertise (SME). Ensure application configurations, data integrity, and cyber...

Global Trade Compliance Senior Manager LIVE What you will do Let's make an impact. Let's shape the future. In this crucial position, you will In this role, you will serve as a Senior Manager within Global Trade Compliance (GTC), part of Amgen's Worldwide Compliance & Business Ethics organization. You will lead key elements of Amgen's global trade compliance program, providing strategic guidance across sanctions, export controls, restricted-party screening, clinical valuation, and other international trade compliance matters. You will be responsible for Amgen's enterprise framework for screening counterparties, transactions, and ownership structures under regulations administered by the U.S. Department of the...

This position works out of our Atlanta, GA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Senior Quality Engineer serves as the quality leader for assigned manufacturing operations and provides technical leadership across quality engineering activities. This role drives quality strategy, mentors quality engineers, leads complex investigations and improvement initiatives, and serves as a key partner to Operations leadership in achieving quality, compliance, and business objectives. What You’ll Work On Strategic Quality Leadership...

Validation Engineer – Casa Grande, AZ Nutrition Plant This position works out of our Casa Grande, Arizona 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. Casa Grande, AZ., is one of Abbott’s leading nutrition manufacturing plants in the U.S., reflecting our commitment to...

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, GCP Auditing to join our Global Development Quality Assurance (GDQA) team, supporting clinical development activities across our global portfolio. You will build strategic partnerships leading risk-based quality audits across investigator sites, service providers, and internal processes, ensuring our clinical studies meet the highest standards of GCP compliance, while collaborating with study teams, cross-functional partners, and regulatory colleagues around the world. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful...

Primary Responsibilities Providing a leadership and technical supportive role in the areas of Steam Sterilization, Dry Heat Depyrogenation, Steam Decontamination, Vaporized Hydrogen Peroxide Decontamination, Controlled Temperature Unit Temperature Mapping and Warehouse Temperature Mapping Performance Qualification Validation activities (but not limited to); Scheduling and executing PQ Validation activities Scheduling and managing PQ protocol close-outs Performing technical investigations and analyses Driving to and recommending corrective actions and seeing them through to successful/sustainable implementation Reviewing procedural revisions to be compliant with regulatory expectations Data analysis and Second Person Review Troubleshooting activities associated with all aspects of PQ execution Final report and procedure writing...

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

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

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

Sr. Associate Quality Control- Microbiology What you will do In this vital role you will perform critical testing and analysis to ensure the quality, safety, and consistency of our products before they reach patients. Specific responsibilities include but are not limited to Perform routine and sophisticated analytical testing with precision and accuracy, ensuring compliance with SOPs and regulatory standards. Maintain meticulous documentation in systems such as LIMS, CIMS, and LMES, following Good Documentation Practices. Serve as a subject matter expert on cGMPs and SOPs, mentoring peers and modeling adherence to safety and quality protocols. Troubleshoot testing issues independently and...

QA Manager What you will do In this vital role you will oversee the daily operations of the quality assurance team, ensuring that the company's products meet established quality standards. They implement and manage QA systems, coordinate audits, and lead initiatives to address and prevent quality issues. Responsibilities Partner with our colleagues in manufacturing, supply chain, facilities and engineering and automation to maintain our strong culture of quality and safety and ensuring the facility operates successfully, efficiently, compliantly, and safely. Provide quality oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities. Lead the quality assurance team...

That’s what makes us Roche! As a Regulatory Innovation & Sustainment Professional within Pharma Development Regulatory’s (PDR) Quality & Compliance capability, you will be accountable for creating and maintaining PDR’s Quality Management System (QMS) framework. This includes fostering innovation, identifying and implementing continuous improvement opportunities and developing risk-based quality strategies. The Opportunity Act as a trusted partner to senior business stakeholders, leading or supporting cross-functional collaboration to ensure global quality standards are met while navigating complex regulatory landscapes. Collaborate with global teams to mature and sustain PDR’s Quality & Compliance capabilities. Monitor external trends and regulatory changes to ensure ongoing...

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

This Compliance Manager, Neuromodulation position is located in Austin, TX. At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 103,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve. What You’ll Work On Abbott is currently seeking an experienced professional responsible for...

This position works out of our Barceloneta location in the AV division at second shift . As a global leader in Medical Devices Technologies. Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. What You’ll Do Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Learns to identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by disposition of non‐conforming material, assessing in identification of primary root causes and understanding corrective and preventive actions . May be responsible for working with process owner to bound product stops and document release...

General/ The Senior Director, CGT Quality Systems, Personalized Medicine provides strategic Quality leadership for personalized medicine and advanced cell therapies across the patient journey. The role is accountable for advancing Quality oversight, governance, compliance, and continuous improvement while ensuring efficient, patient-centric process across the end to end patient journey. This highly cross-functional position requires strong matrix leadership and partnership with Global Quality and Manufacturing, MS&T, Regulatory, Commercial, and Supply Chain stakeholders. Success requires the ability to influence enterprise decisions, build strong partnerships, and drive alignment through executive presence and effective communication. The ability to balance long-term vision with flawless execution...

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. Our Quality Assurance team works closely with Manufacturing Operations to ensure our products are made safely and to the highest...

Will typically serve as the head of the laboratory operations for the plant. Responsible for management of the QC Laboratory organization which may include management of Managers, Supervisors and Analysts. Manages a business unit consisting of one of the following disciplines API Laboratory Operations, Finished Goods Laboratory Operations, Raw Material/ In-Process Laboratory Operations, Laboratory Support Operations, and Laboratory Continuous Improvement/Compliance Operations. Responsibilities Manage a team of Managers, Supervisors and Lab Analysts. Is responsible to hire, lead and develop team members to ensure that the department has the appropriate talent and level of performance to meet business objectives. Assure training and...

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

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for Director, Medical Device Interface, Regulatory Affairs. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you...

The Clinical Study Quality Lead (SQL), Associate Director is responsible for advanced quality assurance oversight of clinical trial operations and applicable vendors, across a range of study phases within assigned disease area(s). The SQL will ensure clinical trials are conducted in accordance with GCP requirements, applicable protocols, Vertex policies and procedures and quality standards as set forth in the Quality Management System. Overall, the SQL is responsible for the development and execution of audit/quality plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, real-time study inspection readiness oversight, and collaboratively identifying and driving inspection preparedness...

Senior Director, Regulatory Affairs - Global Regulatory Leader – Oncology What you will do Amgen is seeking a Senior Director, Regulatory Affairs supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this vital, product-facing role you will lead one or more the Global Regulatory Teams (GRT) in the Regulatory Affairs organization. The purpose of the Global Regulatory Affairs Senior Director is To lead GRTs within Amgen’s GRAAS organization To independently develop a comprehensive regulatory strategy for one...

We are seeking a Principal Regulatory Affairs Specialist to join Abbott’s Vascular Division on-site in St. Paul, MN. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. The individual may...

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

Quality Engineer I This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Quality Engineer I, you’ll have the chance to provide process/quality engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Also provide process/quality engineering support to product development teams, helping to ensure development of highest quality new products. What...

Sr. Quality Specialist This role offers the opportunity to lead complex quality and regulatory initiatives that directly impact patient safety, compliance, and business operations. The individual will be responsible for complaint assessments, regulatory reporting decisions, and the preparation of submissions such as MDRs, MedWatch, and Vigilance reports while serving as a key liaison with regulatory authorities and customers. The position also provides significant cross-functional leadership exposure, partnering with teams across complaint handling, customer service, medical affairs, product quality, and clinical research to drive process improvements and quality system effectiveness. In addition, the role owns critical supplier quality activities, including...

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

Responsible for assisting with the internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards. Responsibilities Assists with planning and conducting internal compliance audits of all operations within the facility. Provides support with company and regulatory agency (i.e. DEA, FDA) inspections. Follow up on audits to assure that action plans are developed and completed in a timely fashion. Assist with management review and associated metrics for the plant Provides support in the metrics collection and analysis for compliance-related corrective and preventive actions (CAPA’s). Responsible for...

The Manager of Quality & Compliance (Q&C) reports into the Associate Director of Q&C for AbbVie Patient Services. This role is responsible for overseeing and improving upon established compliance and quality system processes associated with patient support programs (functional areas of responsibility will include Field Reimbursement Managers (FRM) and Customer Solutions Specialists (CSS). This person should be familiar with quality management system processes (CAPA, Training, Audits, Metrics and Monitoring) as well as change management, process mapping and continuous improvement tools. This role will support the implementation of the Patient Services Q&C Roadmap. This role is also responsible to maintain a...

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...

Join us as a Director Quality Assurance , where you will lead and direct the Site Quality Assurance Operations at our Cell Therapy 9950 MCD Rockville manufacturing site. This role offers an opportunity to develop strategic and operational plans, lead high-level projects, and define innovative solutions within complex areas of the business. You will be working on diversified tasks with a global team, providing you with exposure to new ways of thinking and helping us grow collectively and as individuals. What you will do Lead the new Quality Assurance team at the Commercial Cell Therapy Facility, supporting facility start-up and...

We are searching for the best talent for the Process Quality Leader located in Cornelia and Athens, Georgia. Purpose the Process Quality Leader will Supervises individual contributors and/or Supervisors, and is accountable for conducting effective performance management. Evaluates existing processes, analyzes implemented changes, and recommends adjustments to workflows, schedules, or other processes. Executes and coordinates studies aimed at improving product quality, efficiency, and reliability. Certifies internal quality audits and provides reports on quality metrics to the other members of the Quality and management teams. Oversees a team of Business Process Quality associates and trains them on the latest product standards...

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

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

We are searching for the best talent for a Senior Supervisor, Quality Control to be based in Jacksonville, FL. 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....

The Senior GCP Operational Quality Manager conducts quality assurance oversight and management activities of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols and Vertex policies and procedures. These activities include the development and execution of study level audit plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, monitoring quality issues and compliance metrics, investigation and CAPA management, and proactive inspection readiness activities. Key Duties and Responsibilities Serves as the Quality Lead for assigned clinical programs providing GCP compliance interpretation, consultation, and other support...

The Senior Medical Director, Patient Safety, Disease Area Safety Head (DASH) will lead all safety and benefit-risk related activities for products within the role's Disease-area and/or Franchise, including pre-franchise products from first in-human clinical trials, into and throughout commercialization. This role will assist Global Patient Safety (GPS) Leadership in ensuring the consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Directly and/or via oversight of direct reports, the role will lead pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions...

The Manufacturing Process & Technical Quality Associate Director provides end-to-end l quality oversight for cell and gene therapy programs across clinical development, commercialization, product launch, and post-approval lifecycle management. The role is responsible for establishing product quality standards for both established and emerging technologies, ensuring alignment with regulatory expectations and industry best practices, and proactively identifying and mitigating product quality risks throughout the product lifecycle and end to end patient journey. This position partners closely with Manufacturing, Technical Operations, Regulatory Affairs, and Quality stakeholders to support program execution and governance, ensuring business, regulatory, quality, and operational objectives are achieved while...

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...

Our location in Lake County, IL currently has an opportunity for Sr IT Compliance Analyst – CAPA. Establishes and maintains productive relationships with all levels in the BTS and Divisional IT organizations and business functions. Acts as a liaison and IT Compliance expert to assure successful investigations and corrective actions . Serves as a source of information on the IT Compliance needs and regulatory environment. What You’ll Work On Leads the IT Compliance activities for specific CAPA (Corrective and Preventive Action) event evaluations, investigations, and resolution planning. Assembles CAPA CFT (cross-functional team) team with all needed parties/expertise to effectively and...

Job Title Senior Development Quality Engineer This position works out of our Plano, TX location in the Neuromodulation division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. As a Senior Design Quality Engineer , you will play a pivotal role in advancing the safety, quality, and performance of innovative Class III medical devices throughout the product lifecycle. This position leads risk management strategy across product development, post-market surveillance, supplier changes,...

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

Lead Engineer (Design Quality Assurance) This position works out of our Princeton, NJ location in the Abbott Point of Care 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 Lead Engineer (Design Quality Assurance) will work in the Quality Assurance organization at the Abbott Point of Care Princeton. What You’ll Work On Primary on-market quality assurance support for design control activities. Provide guidance and...

Abbott Nutrition in Casa Grande, AZ is seeking a Quality Engineer to join our team. The Quality Engineer is involved in all aspects of the manufacturing operation from assessing equipment needs, to documenting installation, qualification, and ongoing validation of equipment and processes. The Quality Engineer is also expected to assist in the identification and resolution of quality related issues and work with other areas to resolve issues. This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children...

The Senior Vice President, Chief Ethics & Compliance Officer will be accountable for developing, evolving, and administering Gilead's ethics and compliance programs to ensure compliance with all applicable laws, rules, and regulations. Reporting to Keeley Cain Wettan, the Executive Vice President, General Counsel, the Chief Ethics & Compliance Officer will drive a culture of ethical and compliant yet commercially sound decision making and be an enterprise business partner across Gilead's business. The Chief Ethics & Compliance Officer will play a critical role across the organization, partnering with senior leaders to establish, model, and reinforce the highest standards of ethical behavior...

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

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

Duties/Responsibilities The Sr. Engineer I, Validation will play a critical role in ensuring compliance with all regulatory requirements and industry standards related to GMP asset management and validation in a regulated GMP manufacturing facility. This position requires a hands-on validation engineer with experience in GMP, an understanding of lab/manufacturing equipment, and a proven track record in validation processes. Establish validation protocols, risk assessments, and qualification plans to support GMP operations. Acts as a validation Subject Matter Expert (SME) providing support to multi-function teams, advises operations on validation matters, and potentially serves as the point of contact to present validation programs...

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

The Senior Specialist of Quality Assurance Lot Disposition (QALD) is a full-time position at the Bristol Myers Squibb (BMS) Bothell, WA Cell Therapy manufacturing site. The primary focus for this role is to ensure final drug products and incoming raw materials are released to market following all internal procedures and cGMP requirements. This position reports directly to the Senior Manager of Quality Assurance – Lot Disposition. Duties/Responsibilities Conduct routine lot disposition activities for finished drug products and incoming raw materials by ensuring all relevant documentation associated with a lot are accounted for, completed, and approved under cGMP standards. Generate, review...

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

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

Why Genentech We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world’s most complex health challenges and transforming society. Public Affairs & Access (PAA) is a multi-disciplinary organization that includes Corporate Communications; Policy, Evidence & Access Strategy; Channel & Contract Management; External Affairs; Patient Experience; and Strategy and Business Operations. Our purpose is to deliver impact through a fully integrated public affairs function that leverages our capabilities and world-class Genentech brand to deliver on our...

At Biogen, we are pioneers in neuroscience. The role of the Associate Director requires the ability to provide regulatory strategic advice primarily for U.S. communications related to disease education, promotional materials and medical/scientific materials for healthcare providers, payors and patients in support of Biogen business objectives. The role may also require review of global, corporate, clinical trial, and pipeline materials and communications. This individual will effectively partner and collaborate with cross-functional stakeholders and ensure that materials are competitive and compliant with applicable FDA regulations and guidances, PhRMA guidelines, and Biogen policies. What You’ll Do Provide regulatory strategic input, risk assessment,...

Summary This position is critical to maintaining quality oversight and ensuring GMP compliance in day-to-day manufacturing operations. The Senior Field QA Specialist is responsible for reviewing Manufacturing Batch Records (MBRs), performing real time on-the-floor exceptions reviews and logbooks, conducting GMP area walkthroughs, and supporting timely return-to-service (RTS) walkthroughs to confirm that manufacturing areas and equipment are properly cleaned, calibrated, and ready for production use. The role also working closely with Manufacturing Operations to investigate and resolve manufacturing issues as they arise. Additionally, this position contributes to authoring and revising quality SOPs, supporting the review and closure of no-impact manufacturing deviations,...

Verily is looking for a Counsel, Healthcare & Privacy to serve as a broad-based legal advisor across our provider-facing healthcare business, with deep expertise in healthcare privacy. Reporting to the Deputy General Counsel - Enterprise, this role will partner closely with teams across the company to navigate the complex regulatory landscape at the intersection of healthcare delivery, technology, and data privacy — helping Verily build innovative, compliant solutions that improve health outcomes. This is a high-impact opportunity for a healthcare attorney who thrives on variety, enjoys being a hands-on business partner, and wants to bring deep privacy expertise to bear...

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

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

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

In this key role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities. Key responsibilities include Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans Conduct the formal review and approval of authored documents, following applicable standard operating procedures With limited supervision,...

Senior Associate Quality Assurance / Aseptic Coach What you will do Let’s do this! Let’s change the world! The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our 24/7 Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements. Duties include but are not limited to Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual Visual Inspection support, ASP/AQL...

The Senior Specialist, 880 Safety & Quality Compliance Operations, is responsible for establishing and sustaining a culture of safety, quality, and compliance across Building 880 FLEx Non-Sterile Operations, in partnership with the FLEx Non-Sterile Compliance, Safety & Quality Operations Lead. This role supports Building 880 in maintaining and continuously improving GMP compliance, safety performance, quality system governance, audit and inspection readiness, deviation and CAPA management, training compliance, risk management, and continuous improvement initiatives that support reliable execution of the clinical supply pipeline. The position partners closely with Production, Tech Ops Engineering, Process Engineering, Formulators, Quality, EHS, Supply Chain, and Site...

The Counsel, AI Governance, Law & Compliance provides day-to-day legal and compliance support for the design, development, deployment, and ongoing oversight of AI systems across the enterprise. Sitting within the AI, Data and Privacy Law and Compliance department and reporting to the Head of AI Governance, Law and Compliance, this role partners closely with Business Insights and Technology (BI&T), Privacy, Data Governance, and business stakeholders to operationalize the company's global AI governance framework. The Counsel translates evolving AI laws, regulations, and standards (e.g., EU AI Act, OECD Principles, NIST AI RMF, ISO/IEC 42001, CPPA ADMT, China PIPL) into practical guidance,...

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

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

We are recruiting for a Senior Regulatory Affairs Manager to join our Digital Solutions team on-site in Sylmar, CA or Santa Clara, CA. In this role, you will combine knowledge of scientific, regulatory and business issues to enable products to meet required legislation. Additionally, will be responsible for compiling regulatory submissions and ensure data is effectively presented for the registration of products worldwide. What You’ll Work On Regulatory Strategy & Product Lifecycle Management Contribute to and execute global regulatory strategies supporting product development, registration, commercialization, and lifecycle management. Provide regulatory guidance to cross-functional teams on product development, clinical evaluation, manufacturing...

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

Johnson & Johnson is hiring for a Senior Quality Compliance Engineer– Shockwave Medica l to join our team in Santa Clara, CA . At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Fueled...

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins 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. Assures that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs. The Senior Manager 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...

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and...

We are recruiting for a Regulatory Affairs Specialist III to join our team on-site in Buffalo Grove, IL. 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. Our FreeStyle Libre continuous glucose monitors have revolutionized the way roughly 7 million people worldwide manage their diabetes. This new team member will support manufacturing/operations day-to-day activities for change control and provide regulatory direction on team activities. The individual will apply regulatory understanding to support of product...

This position works out of our Princeton, NJ location in the Abbott Point of Care (APOC) , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Regulatory Labeling Lead will serve as the subject matter expert for regulatory labeling strategy across the i-STAT global IVD product portfolio. You will provide strategic guidance on labeling content, regulatory interpretation, and governance while partnering with Regulatory Affairs, Quality,...

Job Title Quality Systems Specialist We currently have an opening for a Quality Systems Specialist for the Vascular division. This role is located at our St. Paul, MN location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. MAIN RESPONSIBILITIES The Quality Systems Specialist will directly support tasks around current integration projects. Will analyze quality standards for components, materials or services. Applies measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met. Apply quality principles, analyzes quality records, prepares reports and recommends improvements....

This position works out of our Woodridge site in St. Paul, MN location in the Structural Heart Division. Structural Heart Business Mission Why We Exist Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. As a Supplier Quality Engineer II you will lead efforts to enhance and correct the quality of components from external suppliers. Establishes acceptance criteria for materials. Tracks supplier performance to enforce corrective actions, address manufacturing yield issues, and resolve field failures. Coordinates supplier-initiated changes with cross-functional teams . What You’ll...

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

To coordinate and author complex regulatory documents needed for regulatory submissions ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members for assets in the immunology and cardiovascular therapeutic areas. Implements regulatory documentation standards that support speedand consistency of regulatory submissions across all full development / life cycle management assets and geographies. Key Responsibilities Author complex clinical documents needed for regulatory submissions (eg, Pivotal Phase 3 CSRs, CTD summary documents, Pediatric Investigational Plans, Investigator’s Brochures, HA Briefing Books, responses to Health Authority queries) for timely submission to health authorities worldwide according to good documentation...

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

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

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

We anticipate the application window for this opening will close on - 22 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life As one of three comprehensive portfolios at...

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...

This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. The Senior Software Quality Engineer – Design Controls will be responsible for (but not limited to) the following Participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products to ensure medical device software is developed, tested and deployed in adherence to design...

The successful candidate will work within the QC team, testing gene therapy products utilizing cell-based assays (Potency assay) in support of clinical and commercial lot release and stability activities. These assays are conducted in-house at the Sarepta facility in Andover, MA., with additional testing performed at contract testing laboratories (which may require periodic SME support). The successful candidate will have hands-on experience with cell-based in-vitro potency assays, cell culture, SDS-PAGE, western blot, Automated Western blot assays, enzyme activity measurements, protein extraction, purification, and quantification methods. The required work involves handling and testing samples in a BSL-2 environment. All aspects of...