Quality & Regulatory Jobs in Pharma & Biotech

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...

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

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals....

Associate Quality Control - Microbiology What you will do In this vital role, you will be responsible for analytical testing, sample and data management, method development, and product characterization. You will support Quality Control operations in a non-standard shift environment, helping ensure the highest standards of product quality and compliance. Perform routine and non-routine laboratory procedures, including aseptic aliquoting and analysis for both compendial and non-compendial methods. Conduct or support activities such as sample testing, standards and reagent preparation, environmental monitoring, sample management, and equipment maintenance. Ensure accurate, complete, and timely documentation of laboratory work, and participate in document...

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 Senior Counsel, Data Governance, Law & Compliance provides legal and compliance leadership for enterprise data governance initiatives at Bristol Myers Squibb. Sitting within the AI, Data and Privacy Law and Compliance department and reporting to the Head of AI & Data Governance, Law and Compliance, this role partners closely with Business Insights and Technology (BI&T) to advance the company's data governance framework across R&D, Commercial, Medical, Manufacturing, and enabling functions. The Senior Counsel translates evolving global data and AI requirements into practical policies, controls, and guardrails that support responsible data use and AI adoption in a highly regulated life...

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 - 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 Across our global Neuroscience organization, we advance...

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 - 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...

You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Open to candidates based at Medtronic locations across the U.S. Responsibilities may include the following and other duties may be assigned Lead and develop a high-performing...

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 anticipate the application window for this opening will close on - 8 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 A DAY IN THE LIFE The Senior...

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...

Job Title Director, Regulatory Affairs Strategy - Cell Therapy 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 global teams, you will lead strategy across key milestones—from expedited designations and Health...

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...

Sr. QE for Design Quality – Lifecycle Management Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetic Devices, etc. Responsibilities Perform QA activities related to Combination Product and Medical Device Design Transfer and Change Management Ensure compliance with company policies and procedures. Perform design control and risk...

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 Temecula, CA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for...

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...

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the needs of those we serve. By being part of our team, you play a crucial role in maintaining this high standard and making a difference in the lives...

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 - 10 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 Our Cranial & Spinal Technologies (CST) operating...

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 Senior Director, Clinical Quality & Development Operations (CQDO) Good Clinical Practice (GCP) Compliance provides enterprise‑level leadership and strategic oversight to ensure Global Clinical Operations (GCO) maintains a sustained state of GCP compliance. The role is accountable for embedding a proactive GCP compliance capability, provides strategic oversight and governance for GCO owned Risk Management Plans (RMPs), clinical site holds and closures, Quality Risks, and Serious Breach assessments, ensuring proactive risk identification, regulatory compliance, and effective quality risk mitigation across the clinical development portfolio. Through leadership of a high‑performing CQDO team, this role ensures quality and compliance are consistently aligned with...

Abiomed is recruiting for a Director, Service & Repair Quality located in Danvers, MA or Aachen, Germany. Remote work options may be considered on a case-by-case basis and if approved by the company. 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 Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply...

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

The 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 are searching for the best talent for a Process Quality Leader to be located in San Angelo, TX . 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 Under the direction of the Business Unit Manager, the Process Quality Leader provides technical leadership in identifying causes of non-conformances and process failures and supporting the implementation of associated remedial, corrective, and preventive actions. This role is responsible for ensuring process performance...

We are searching for the best talent for a Process Quality Specialist to be located in San Angelo, TX ! About Johnson & Johnson MedTech Fueled by innovation at the intersection of biology and technology, Johnson & Johnson MedTech is developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Under the direction of the Process Quality Leader, the Process Quality Specialist provides technical support and quality expertise to help identify causes of non-conformances and process failures and support the implementation of associated remedial, corrective, and preventive actions....

Johnson & Johnson Vision, a member of the Johnson & Johnson family of companies, is recruiting for a Sr Engineer Sr Engineer, NPI and Lifecycle Quality , located in Irvine, CA. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The Sr Engineer, NPI and Lifecycle Quality provides quality and technical leadership to ensure new and...

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...

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,...

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...

The Quality Control Technician performs final inspection of finished goods in accordance with established procedures, documents inspection results in the applicable quality system, and supports product release activities. This role is part of a dynamic team that interfaces closely with the product release and packaging departments to help ensure seamless product flow and timely delivery. The Quality Control Technician also contributes to problem-solving efforts, including nonconformance investigations, rework, and continuous improvement initiatives. Responsibilities Perform final inspection of products in accordance with established procedures, including visual inspections and final packaging checks, to ensure labeling, packaging, inserts, and other components conform to...

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. Assures that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual has responsibility for products/multiple driver indications for a product within a Therapeutic...

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. A Senior Laboratory Technician, Quality Control is responsible for performing advanced laboratory procedures independently for the testing of veterinary biologicals...

Are you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the research, development and commercialization of our products across the portfolio! About AstraZeneca At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about...

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

Specialist Quality Assurance Location Easton, Pennsylvania - ON-SITE - Second Shift What you will do Let’s do this! Let’s change the world! This onsite position provides critical support for the Raw Material Center (RMC) warehouse, based in Easton, Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network, serve additional manufacturing sites, and facilitate inventory pooling and bulk purchasing. RMC services encompass direct supplier receipt, incoming quality inspection and sampling, environmental monitoring, storage, and transportation. Responsibilities Ensure that all operations align with relevant regulations and Amgen requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution...

QUALITY COMPLIANCE, DIRECTOR What you will do In this vital role you will report to the Executive Director of Regulatory Compliance and primarily provide direct support for compliance related deliverables associated to new sites or expansion of existing manufacturing sites. Serve as a strategic partner supporting the Quality Improvement Plans (QIP) and Operational Readiness program by providing independent compliance expertise, and objective guidance to support sustained GMP readiness and operational excellence. Partner closely with QA Operational Readiness Team and cross-functional leadership to evaluate remediation strategies, operational readiness initiatives, and quality system enhancements, ensuring alignment with global quality standards, regulatory...

We anticipate the application window for this opening will close on - 10 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...

We anticipate the application window for this opening will close on - 14 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 - 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 Position Description The Design Quality Engineer II,...

We anticipate the application window for this opening will close on - 7 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 Business Group Global Quality / Enterprise Quality...

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 Across our global Neuroscience organization, we advance...

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 is seeking a highly skilled...

This position works out of our Dallas, TX location in the Core Lab , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Specialist Quality Assurance will analyze customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR)...

This Regulatory Affairs Specialist will work out of our Pleasanton, CA location in the Heart Failure Division. As an individual contributor in the function of a Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department. With limited supervision you will execute tasks and partner across business functions. As an individual contributor, the Regulatory Affairs Specialist will support product registration and regulatory activities . What You’ll Work On As a professional in the Regulatory Affairs Sub-Function, possesses develop ing skills in product registration submission, change order management, progress reports. Interacts with regulatory affairs team members and...

Position Overview At Exact Sciences, we are cancer fighters. We are united by our mission to change lives by providing earlier, smarter answers. Through advances in cancer detection and treatment guidance, we will help eradicate the disease and the suffering it causes. This Engineer I, Quality role will be involved in all phases of system development including requirements, analysis, design, testing, and support. The ideal candidate must demonstrate the ability to understand system architecture, design, implementation and possess the ability to succinctly develop the testing strategy to deliver high-quality results in a time-sensitive environment. Essential Duties Include, but are not...

Manager / Sr. Manager, Global Supplier Quality The Manager, Global Supplier Quality is a critical role in maintaining supplier quality compliance, ensuring accurate supplier data, and supporting the operations, effectiveness and improvement of the supplier management lifecycle, supplier notification assessment process, supplier quality master data management, and proactive maintenance of the approved supplier list. This role drives compliance, risk-based decision-making, and data integrity across supplier-related processes while supporting cross-functional alignment and continuous improvement initiatives within Gilead’s Quality Management System (QMS). Key Responsibilities Supplier Notification Assessment (SNA) Management and Coordination Manage the Supplier Notification Assessment (SNA) lifecycle from initial intake...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. We prefer a candidate that is site-based (local to Foster City). You will be on site Tuesday, Wednesday, Thursday. For non-local talent,...

We anticipate the application window for this opening will close on - 15 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 is an add position with a...

We anticipate the application window for this opening will close on - 14 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 Quality Program Director will lead the...

About This Role As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you will lead a dynamic team within the PO&T function, driving the regulatory strategy for biologics and ATMPs in Biogen’s portfolio. Your role encompasses global, regional, and local accountability for all therapeutic areas relevant to these modalities. You will manage resources, set a vision, and ensure alignment between regulatory strategy, technical development, and manufacturing execution. By leading multiple projects in a fast-paced environment, you will play a crucial role in delivering on our product portfolio, providing strategic oversight to ensure timely approvals and...

The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) - Biologics Product Lead , works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision. Builds and maintain relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers...

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...

You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. We must work with a sense of purpose and ownership, knowing there is a human life on the other side of every decision. In this enterprise leadership role, the Director, Quality Center of Expertise – Design Quality will advance Design Quality excellence across Medtronic by shaping strategy, standards, governance, and performance visibility for critical product development and quality system capabilities. You will partner across Operating Units, Regions, and Core Quality Services to simplify and standardize Design Quality practices, strengthen inspection readiness, and enable consistent execution...

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

The Biologics Development Quality group in Rahway (BDQR) within Global Development Quality is responsible for technical, operational and quality oversight of a growing and fast-moving large molecule pipeline. BDQR is specifically focused on quality oversight for large molecule drug substance process & analytical development, GMP clinical manufacturing, and the testing & release of clinical supplies. The Senior Specialist, Quality Assurance BDQR is responsible for providing Quality oversight and technical support for analytical and process development activities supporting large molecule programs, while ensuring compliance with cGMPs, applicable worldwide regulations, and our Company requirements for supported area(s). The Senior Specialist applies...

Associate Director, Global Supplier Quality The Associate Director, Global Supplier Quality serves as the global program owner providing leadership for the GMP materials supplier change notification and assessment processes, supplier data governance, and proactive approved supplier list (ASL) maintenance, utilizing risk-based decision making and actions, operational excellence, and continuous improvement to deliver Global oversight of supplier changes affecting the Gilead network with effective governance and global engagement for the supplier change notification and assessment process. Accurate and compliant Approved Supplier List management. Robust supplier master data integrity across enterprise quality and business systems. Meaningful supplier quality metrics and performance...

Associate Director, Cell Therapy Trade Compliance Operations Introduction to role 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. As our network, geographic footprint, and operational complexity continue to expand, trade compliance operations are increasingly critical to ensuring that patient materials, critical manufacturing inputs, intermediates, and finished product can move compliantly, predictably, and without avoidable delay across borders. The Associate Director, Cell Therapy Trade Compliance Operations leads the operating model for import/export and Free Trade Zone (FTZ) execution across the cell therapy network. This...

The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives. Accountabilities/Responsibilities Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large...

Clinical Regulatory Writer, Associate Director or Manager Location Boston, MA - Hybrid (3 days onsite) Introduction to role Are you ready to be part of the solution, turning drug development strategies into reality? As a Clinical Regulatory Writer, you will play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca’s core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals. Accountabilities As a Clinical Regulatory...

The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management experience and a track record of advancing innovative therapies through key clinical development milestones. As a key member of the global regulatory strategy team (GRST), you are responsible for partnering with senior regulatory experts to support the end-to-end regulatory strategy planning, coordination, and execution of assigned cell therapy projects. The ARAD is solutions-oriented and a key contributor to regulatory strategy development, the identification of submission risks and opportunities, and drives high quality global regulatory authority engagements and submissions. The ARAD provides regulatory expertise and guidance...

Clinical Regulatory Writer, Associate Director / Manager Location Gaithesrburg, MD- Hybrid (3 days onsite) Introduction to role Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca’s core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals. Accountabilities As a Clinical...

The Regulatory Affairs Associate (RAA) assists other members of Regulatory Affairs Management (RAM) in obtaining and maintaining licenses and applications in accordance with agreed regulatory strategy and AstraZeneca standards. Accountabilities/Responsibilities Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements. Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches. Be the interface with Health Authority (HA) and its systems for designated regulatory tasks e.g. management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA Portals. Responsible for the...

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

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

Quality Engineer This position works out of our San Diego, CA location in the Infectious Disease , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Quality Engineer is responsible for developing and maintaining quality systems and providing quality system support for the division (e.g. commercialized products, new product development, manufacturing, and/or system compliance). What You’ll Work On Provides Quality System Body of Knowledge...

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

The Director Quality Assurance is responsible for managing the Quality Assurance Department and the Quality System to achieve compliance with Corporate and Division requirements for the Casa Grande, AZ site. They are responsible for leading the compliance inspections and fostering a culture of Quality and Food Safety. The Director Quality Assurance will oversee cGMP, site quality standards and corresponding risk assessments and QA change control processes related to the manufacturing, testing, and release of a variety of nutritional products. What You’ll Work On Establishes and implements Quality Assurance procedures for inspecting and controlling raw or packing materials and assaying in-process...

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

The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and delivering high-quality regulatory submissions, while serving as the primary CMC interface with Health Authorities. The role integrates advanced digital and AI-enabled approaches to enhance the quality, consistency, and efficiency of regulatory document preparation and review. Key Duties and Responsibilities Leads preparation, review, and lifecycle management of CMC sections of global regulatory submissions for biologics (INDs/CTAs, NDAs/BLAs/MAAs) Develops and drives global CMC regulatory strategies for assigned programs Serves as primary regulatory...

The Patient Safety Epidemiology Associate Director leads safety and regulatory epidemiology activities for Vertex products across multiple therapeutic areas and throughout all phases of lifecycle. This includes execution of post-marketing regulatory study research strategies, leading comprehensive epidemiologic feasibility assessments, development of epidemiologic study designs, overseeing study implementation, interpretation of findings and communication to internal and external audiences. Key Duties and Responsibilities Major contributor and driver to the company safety risk management, signal detection, benefit/risk assessments, and post-marketing regulatory research strategies Expected to research the epidemiology of specific disease areas and events of interest, lead evaluation of data sources and data...

Vertex Patient Support (VPS) is seeking an experienced and highly motivated Associate Director, Assurance (AD, Assurance) to serve as a key leader within the US Patient Support Center of Excellence (COE) Program Quality team. Reporting to the Director of Program Quality, the AD provides operational leadership for the execution of the assurance program across Cystic Fibrosis, Kidney, and Hematology Patient Support Programs (PSPs) supporting both GxP and non-GxP functions. The Associate Director will provide oversight for the execution of quality assurance activities, including internal audits and continuous monitoring, corrective and preventive action (CAPA) management, and quality reporting. In collaboration with...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at . Transcend is a global business transformation program that will modernize our foundational transactional processes and harmonize them into one “clean” ERP as a standardized platform for growth and efficiency gains. This program will simplify the Pharmaceutical ERP landscape...

We are searching for the best talent for a Director, Health Care Compliance Officer, Global Functions, for the Innovative Medicine business with responsibilities for areas within the Global Commercial Strategy Organization (GCSO) and Global Business Development. This role will primarily be based in Raritan, NJ. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step...

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...

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...

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

Job Title Sr. Quality Engineer This position works out of our St. Paul, Minnesota location in the Vascular Division. This is a fully onsite role and will support second shift. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. The Senior Quality Engineer will be responsible for providing quality engineering support and leadership within product manufacturing, design...

Purpose AbbVie is dedicated to delivering innovative, safe, and effective medicines and products that address critical health issues and make a remarkable impact on people's lives. As a Global Trade Compliance organization, we are committed to driving and pioneering best-in-class trade compliance practices in a dynamic global environment. The Supervisor, GTC – Tariff Classification, is responsible for ensuring that AbbVie’s cross-border transactions are executed in compliance with import/export regulations worldwide. This Supervisor will play a vital role in the leveraging of technology solutions in the tariff classification area that enables import/export compliance and supports cost savings activities globally. The Supervisor,...

Twist Bioscience is hiring a Quality Control Supervisor at our Wilsonville facility. You will lead daily QC operations, oversee product releases, and drive continuous improvement across our molecular biology testing methods. In this hands-on role, you will build and mentor a team of QC associates while working cross-functionally with R&D, Operations, and Engineering to maintain robust ISO 13485 and GMP compliance. What You’ll Be Doing Operations & Leadership Lead, train, and mentor a high-performing team of Quality Control associates. Monitor and manage daily QC product releases generated by the factory, ensuring proper execution in a timely manner. Method Implementation &...

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

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 Sr. Regulatory Affairs Professional, Global TA , located in Spring House, PA, Raritan or Titusville, NJ. Purpose Global Regulatory Affairs (GRA) is looking for a high energy, inventive, self-starter who...

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 Senior Software Design Quality Engineer role to be located at Danvers, MA. The Senior Software Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a key role in product risk management, cybersecurity, change controls, test reviews, and design controls. This engineer should excel in an environment...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Senior Specialist, Associate Aseptic Process Validation Engineer, Cell Therapy provides process aseptic validation support to the Devens Cell Therapy Facility...

We anticipate the application window for this opening will close on - 5 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 - 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 Experience in the medical device industry as...

Main Purpose Independently or lead a project team of supervisors/engineers/technicians, to support Design/ Development Quality. Identify, plan and conduct projects requiring a combination of conventional and custom risk-managed execution plans as well as design controls deliverables, manages multiple often concurrent projects. What You’ll Work On Provide technical and quality system guidance related to establishing design controls requirements. Development of strategy and leading execution of deliverables for the team or organization and coaching/ mentoring on technical skill on the subject matter. Supports design verification and validation activities for new products in accordance with design planning procedures. This includes, but is not...

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

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

About the role As a Quality Control Analyst II, you will execute and review routine in-process, drug substance, and stability test methods in a timely manner. You will use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower). This shift will be working from Monday to Friday, 200pm-1030pm. How you will contribute Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal). Conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability. Own...

Department - Global Regulatory Affairs and Clinical Safety - Vaccine & Infectious Disease Brief Description of Position- The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and Infectious Disease therapeutic area. Primary activities include, but are not limited to Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. Develops worldwide product regulatory strategy to optimize label...

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

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...

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients. What You Will Achieve In this role, you will Investigate quality issues within manufacturing and quality laboratories Examine deviations, out-of-specification results, and atypical investigations Identify root causes and suggest effective corrective action plans Ensure all...

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

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

The 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...

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...

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...

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

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

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

The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on Safety Data Sheets (SDS), product labeling, and SOP’s. This role is crucial in supporting global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications. What You’ll Be Doing ●Initiate, author, and maintain Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global regulations. ●Collaborate with cross-functional teams to obtain necessary product composition data and hazard information for accurate SDS generation. ●Manage the review, approval, and distribution of SDS to internal and external stakeholders....

About the Role As the Director, Head of Quality Operations, you will play a pivotal leadership role in shaping the future of Clinical Pharmacology and Pharmacometrics Quality (CPMQ). You will partner closely with the Head of CPMQ and the CPMQ Leadership Team to drive strategy execution, organizational effectiveness, operational excellence, and business performance across a global organization. In this highly visible role, you will lead transformation initiatives, advance digitalization and AI adoption, and strengthen the capabilities, processes, and culture that enable CPMQ to thrive. You will champion innovative ways of working, foster a collaborative and inclusive environment, and ensure the...

About the role Join us in leading the future of Quality Control. In this role, you will oversee analytical chemistry, microbiology, and laboratory excellence, driving the highest standards of quality, compliance, and operational performance. Working closely with Manufacturing and Quality partners, you will champion continuous improvement, employee development, and innovation while fostering an inclusive environment where diverse perspectives are valued and everyone is empowered to succeed. The ideal candidate will embody Takeda’s Quality Culture by keeping it simple, encouraging open communication, taking pride in doing it right, and demonstrating an unwavering commitment to quality. How you will contribute Lead QC...

Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The main function of the Associate Specialist, Quality Control is to assist in the assurance of the quality of product through the performance of microbiological, chemical and analytical sampling and assays as well...

That’s what makes us Genentech, a member of the Roche Group! As the Regulatory Policy Analyst , you will be a member of our Regulatory group working with both internal and external stakeholders to proactively shape regulatory environments to enhance patient access to the Roche/Genentech portfolio. In this role, you serve as key contact on regulatory policy and advocacy. The Opportunity You will analyze FDA guidances and other policy documents to inform the business You will conduct regulatory, policy and legal research on topics identified by senior leaders You will conduct external and internal landscape analysis to identify near and...

We anticipate the application window for this opening will close on - 15 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Across our global Neuroscience organization, we advance...

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

Executive Director, GxP Quality Execution Platforms What you will do In this vital role you will lead the strategy, operating model, and lifecycle ownership for enterprise GxP Quality Execution Platforms. This role converts core quality processes from manual, process-centric execution into scalable, workflow-, rule-, and data-driven digital platforms that are inspection-ready, adoption-led, and aligned with the GxP Quality Operating Model. Responsibilities Operationalize the GxP Quality Operating Model vision and strategy evolving from digitized Quality Management System through AI-enabled to advanced AI-orchestrated with full autonomy across foundational quality processes. Relevant to that, own business strategy includes driving development and endorsement...

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 ,...

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

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...

Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations Gaithersburg, MD Boston, MA South San Francisco, CA Santa Monica, CA Introduction to role Are you ready to set the global regulatory vision for pioneering cell therapies and turn breakthrough science into real options for patients? This role leads high-impact programs across cancer, immune-mediated and rare diseases, guiding them from current stage through licensure with clear, competitive pathways to approval and labeling. You will shape strategy for complex, visible programs, bringing clarity, pace and rigor that accelerate access for patients. You will report to the Executive Director, Cell Therapy Regulatory...

The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio. This role provides strategic leadership for complex regulatory CMC activities, oversees Health Authority engagement, and ensures regulatory requirements are effectively integrated into development and commercialization plans. The Director drives organizational excellence through talent development, process innovation, and the application of digital and AI-enabled capabilities to enhance the quality, consistency, and efficiency of regulatory decision-making, document preparation, and submission execution. Key Duties and Responsibilities Leads development and execution of global CMC...

The Manager, Quality Engineering Operations position works out of our Sylmar, CA location in the Cardiac Rhythm Management Division. This is a fully onsite role. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats. The Manager, Quality Engineering Operations m anages experienced QA professionals who exercise latitude and independence in their assignments. Often heads one or more sections/functions or a small quality department. Interprets policies , processes and procedures that may affect sections and subordinate work units. Assignments are defined in terms...

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

We aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We are seeking an experienced and proactive compliance leader to oversee our divisional compliance team to ensure regulatory alignment across our technology landscape. In this role, you will operate with a high degree of independence while championing a culture of transparency and knowledge sharing. You will serve as the vital link between IT and our broader business functions, ensuring that daily operations and major structural investments meet our...

About This Role As a Compliance Officer, you will uphold and promote ethical integrity within Biogen's US business. Your expertise will ensure that our business operations adhere to the highest standards of compliance and regulatory conduct. By developing and delivering comprehensive training programs, you'll be an educational pillar for both new and established employees, fostering a culture of continuous learning and compliance awareness. Your strategic insight will be pivotal in identifying and managing compliance risks. Reporting to the Lead US Compliance Officer, this role is hybrid and based in our Cambridge, MA office, with the understanding that periodic travel is...

We anticipate the application window for this opening will close on - 4 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 - 10 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 will play...

We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in Pleasanton, CA. This team member will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions as well as assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation. What You’ll Work On Develops worldwide strategies for regulatory...

We are seeking a Regulatory Affairs Manager to join Abbott’s Heart Failure Division on-site in Pleasanton, CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the...

The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external sites including evaluating, improving, and monitoring commercial level quality compliance and quality culture. Key Duties and Responsibilities Responsible for inspection readiness and compliance programs for external operations. Works cross-functionally and cross-company to ensure sites achieve and maintain a state of inspection readiness. Drive identification and resolution of issues, gaps and risks through collaboration with operational areas, assessments, audits, and evaluation of trends. Support and oversee inspection execution including responses and closure of CAPAs. Collaboration and Integration Serve as an integrator across multiple...

The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and external sites including evaluating, improving, and monitoring commercial level quality compliance and quality culture. This position provides technical and strategic leadership for inspection readiness and compliance including processes and associated governance across all GMP areas. This position focuses not just on the “what” but the “how”, ensuring phase appropriate and risk-based compliance. Key Duties and Responsibilities Accountable for inspection readiness, inspection management, and compliance programs across all GMP areas including external CMOs and internal manufacturing/testing sites. Monitor and interpret cGMP regulatory guidelines and trends in...

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 currently seeking a Quality Director to join the Quality Team in Wilson, North Carolina. While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both...

Role Purpose / Objective The Strategy Lead, Ethics & Compliance serves as a strategic advisor and governance partner to the Chief Ethics & Compliance Officer (CECO) and is a standing member of the Global Ethics & Compliance Leadership Team (GEC LT). As a standing GEC LT member, the role contributes to decision quality, governance discipline, and enterprise integr ation. Sitting within GLEC Operations – Strategy & Planning, the role strengthens t he effectiveness o f the G E C f unction by translating leadership priorities into clear decision materials, risk and governance-ready narratives, and disciplined follow-through on actions and commitments....

Job Title Sr. Software Engineer, Quality We are seeking a Sr. Software Engineer, Quality . This role can be in any of our Abbott location in the United States. This is an onsite role. MAIN PURPOSE OF ROLE Reviews documentation for accuracy, clarity, consistency, completeness and compliance for multiple projects. Plans and performs assignments with a wide degree of difficulty. Analyzes data, procedures, and requirements with consideration given to financial and business outcomes. Coordinates activities across impacted groups. Accepts ownership and responsibility for decisions. Effectively engages team members and provides guidance to various functions, other professionals, and technicians. MAIN...

The role is responsible for line management of Global Regulatory Strategy (GRS) Therapy group (TG) staff and may also involve individual support for projects as a regional director or GRL. The role reports directly to the GRS TG Portfolio Lead. The Regulatory Director/Team Leader along with the respective Portfolio lead is responsible for Provision of adequate resources to support the various development programs within the respective portfolio. Ensuring the development and effective execution of regulatory strategies for assigned assets. These strategies must be aligned with the Medicines Development Strategy and the Integrated Evidence Strategic (IES), ensuring that the development program...

The Opportunity As the Head, Regulatory Program Management , you will serve as a transformational executive leader holding dual accountability for Chapter capability development and end-to-end global regulatory execution across the entire Roche Pharmaceuticals portfolio (medicinal products and devices). In this high-visibility, fully on-site role, you will act as a senior business leader and trusted advisor to the Roche enterprise (including the Genentech Executive Committee, US functions, and global Roche leadership). Partnering with the OnePDR Leadership Team, you will contextualize the regulatory landscape, ensure financial stewardship over PDR budgets, architect long-term capability strategies, and lead global Health Authority interactions to...

We anticipate the application window for this opening will close on - 15 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Across our global Neuroscience organization, we advance...

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...

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,...

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

POSITION SUMMARY Quality Engineersupports the quality system processes of the Natera CLIA laboratories and activities associated with CE-IVD kits and software. The Quality Engineer works with QE Manager/QA Director to address supplier issues, nonconformances and corrective actions that impact the CLIA laboratory operations.This position will also represent QA on product development projects. Position will be hybrid with 1-3 days onsite a week. PRIMARY RESPONSIBILITIES Support internal and external audits (CLIA/CAP, ISO 13485, customer) Responsible for CAPA, Deviation, Change Requests and Nonconformance investigation and reporting Write/revise procedures and forms; submit to Document Control and assist with training as needed...

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

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...

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

This is a Pipeline requisition, to source candidates for future opportunities in 2026-27. 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 criteria. Assists...

We are seeking a Senior Counsel in Abbott’s global Legal Regulatory and Compliance department, which will support Abbott’s businesses on legal topics relating to the regulation of Abbott’s product offerings, from product development and submissions to manufacturing and quality, product cybersecurity, and marketing practices. This is an individual contributor position reporting to Abbott’s Division Counsel, Regulatory. Preference for the role is to be based in Abbott Park, IL or Chicago, IL. May consider role to be based in Washington DC. What You’ll Work On Responsible for counseling on FDA and state laws, regulations, and guidance documents with respect to complex...

This position works out of our Barceloneta location in the AV division at first shift-8am-5pm . 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 criteria....

We anticipate the application window for this opening will close on - 8 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 ...

OBJECTIVES / PURPOSE Provides enterprise-level governance, operational standards and compliance leadership for Medical-led evidence generation activities within Global Medical. Serves as the primary Medical Governance Office lead for evidence generation operations, ensuring consistent governance, oversight, quality, risk management and inspection readiness across Medical-led research activities while partnering with R&D Quality Assurance as the enterprise quality authority for applicable GxP research activities. Establishes clear governance expectations aligned with Takeda standards, applicable laws and regulations, local requirements, industry codes, enterprise quality frameworks and audit expectations, while continuously evolving governance approaches to leverage digital technologies, data transparency, automation and AI-enabled compliance capabilities. Ensures...

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...

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

The Executive Director serves as a strategic leader responsible for defining and executing the Cell & Genetic Therapies (CGT) Quality vision, operating model, and organizational strategy. The role is accountable for ensuring quality readiness from early development through commercialization while building scalable, inspection-ready quality capabilities across internal manufacturing sites and external partner networks. The position drives enterprise CGT quality leadership, digital innovation, talent development, and risk-based decision making to support the successful delivery of life-changing therapies to patients. The role includes partnering with internal stakeholders to build & coordinate a phase appropriate quality roadmap to commercialization. Key Duties & Responsibilities...

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...

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks . Abbott Vascular provides innovative, minimally invasive and...

Position Overview - Basic Functions & Responsibility Essential function(s) includes, but is not limited to Responsibility for daily operation of cells including coordination of testing and data review to meet due dates, and coordination of Quality Notifications. Drives continuous improvements, lean activities, kaizens and KATA methodology. Performs Quality sampling, testing, and release for bulk raw materials, active pharmaceutical ingredients, water, microbiological limits, primary packaging components and finished pharmaceutical products. Primary Activities Primary activities include, but are not limited to · Drives continuous improvement and supports sustainability of implemented changes identified through such lean tools as Kaizens and / or champions...

At We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence. At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best...

Join the Rahway, New Jersey Animal Health Team Our Company's Global Animal Health division is a pioneer in the discovery, development and registration of vaccines and therapeutics for animals. Our focus is on pioneering research to deliver innovative global health solutions that advance the prevention and treatment of diseases in animals. An experienced and dynamic Executive Director CMC (Chemistry, Manufacturing & Control) GRA (Global Regulatory Affairs) is sought to lead the global pharma CMC regulatory team and oversee the development and maintenance of pre- and post-approval regulatory strategies and submissions. Primary Responsibilities Evaluate workload, ensure timely staffing onboarding, and training....

This is a full time on-site position with M-F business hours About This Role The Sr. Associate I is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. This individual has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. The Sr. Associate I provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in a manner consistent with site and Corporate policies, cGMP, safety,...

The CMC Regulatory Affairs Manager is responsible for supporting the planning, coordination, and execution of CMC regulatory activities across global clinical and commercial programs. This role partners closely with Regulatory Affairs, Technical Development, Quality, and cross ‑ functional CMC teams to support timely , compliant, and well ‑ organized submissions to global health authorities. Responsibilities Coordinate and track timely regulatory assessments of CMC change controls to support global filing impacts for the development of CMC filing strategies and timelines Support and track CMC regulatory project activities, including global quality dossier preparation, global dossier lifecycle submissions, approval, and Health Authority communications/interactions....

Leads and manages Computer System Validation (CSV) efforts for enterprise GxP systems used across multiple functional business organizations. Collaborates with IT Delivery teams, business users and internal Global Quality staff to ensure that CSV activities are planned and executed in accordance with internal procedures. The role is expected to actively leverage AI as an accelerator for validation deliverables, requirements analysis, review efficiency, testing, and documentation quality, while applying appropriate governance, human oversight, and compliance expectations for GxP systems. The position also promotes the use of test automation, agile CSV practices, and other technical innovations to improve execution efficiency, consistency, traceability,...

The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product’s lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program & provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain database to address external questions regarding drug products. The GRS-CMC Associate Director is responsible for content development, compilation, maintenance, and review of the...