Quality & Regulatory Jobs in Pharma & Biotech

Lead or co-lead for one RA CMC development and/or marketed product and provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. Works closely with subject matter experts within CMC technical operations and QA working within a CMC sub-team structure and serving as a member of the GRT. Contributes to the development of fit for purpose high quality documentation (e.g., INDs, CTAs, NDAs, reports, and correspondences) to support global Health Authority interactions. May oversee activities of junior regulatory personnel. Builds/maintains relationships globally and cross-functionally to ensure effective communication & efficient implementation of regulatory activities for assigned programs. Applies and further...

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...

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. What You Will Achieve In this role, you will Author, review, and /or approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements. Perform a variety of Validation activities in compliance with Good Manufacturing Practices (GMP) and Validation Master Plan...

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 Senior Director, Device Quality provides strategic Quality leadership and oversight for Vertex device and combination product operations across development, manufacturing, testing, clinical, commercial, and post-market activities. The role is accountable for risk-based operational Quality oversight of internal activities and external partners , including CDMOs, testing laboratories, and critical suppliers. The role ensures compliance with ISO 13485, 21 CFR Part 820, ISO 14971 , and applicable global device and combination product requirements. The Senior Director serves as the Management Representative for the Device QMS , providing leadership for QMS effectiveness, regulatory compliance, management review, inspection readiness, and continual improvement. The...

We are seeking an experienced environmental compliance specialist with technical expertise and deep knowledge of federal, state, and local air program environmental regulations pertaining to the pharmaceutical industry. The successful candidate will have a strong background in permitting and compliance management for air pollution sources and refrigerant management with a track record of successful implementation of compliance programs. The role also involves supporting EHS planning and execution and requires effective influencing skills to help drive EHS performance within a complex organization. Role Overview Reporting to the Associate Director / environmental compliance lead for the West Point Site, the S&E Specialist...

Our Global Privacy and Digital Trust Program is grounded in organizational accountability, responsible data stewardship, consistent global practices and standards, and ongoing oversight to ensure we adapt to evolving regulatory expectations as technology and the business continue to transform. The Associate Director, Digital Compliance, will help enable the compliant and responsible adoption of emerging technologies and digital solutions across our organization. This role will help shape the future of our company AI governance program, acting as a trusted advisor to business units, and fostering a culture of responsible technology use across the organization. Primary Responsibilities Facilitate the expansion, implementation, and...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer to be based in Titusville, NJ or Horsham, PA. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Purpose The Senior Manager, Health Care Compliance Officer serves as a strategic healthcare compliance partner...

Serves as primary Quality Assurance associate supporting the day to day manufacturing operations in the Jacksonville IOL manufacturing site. The individual performing this role will have to create a strong network base with the line supervisor(s), technicians and engineers to address all the opportunities found in the assigned manufacturing line or quality system process Overall responsibilities include planning, conducting and directing engineering projects or studies requiring general technical knowledge. Applies basic engineering principles and practices within assigned areas. Utilizes basic Quality Engineering tools and practices to support the effective and efficient development, transfer and maintenance of products/processes throughout the product...

Johnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control Analytics - CAR-T in Raritan, NJ! This shift is going to be scheduled 800am - 600pm through Sunday - Wednesday. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare...

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

SECTION 1 JOB SUMMARY* This position will provide Worldwide Source Compliance leadership in the development, implementation and continuous improvement of Source Compliance programs associated with Suppliers (External Manufacturers, Direct & Indirect Suppliers) associated with the business. They will be responsible for ensuring the post audit activities are executed per established procedures, such as Supplier Audit Response support & alignment, supplier action plan follow-up & closure, EM follow-ups, metric reporting, and support as needed for the maintenance and continually improvement of the Source Compliance process. They will engage with business partners, such as Supplier Quality & supplier relations and Suppliers. In...

The Quality Engineering Manager provides quality leadership and technical oversight for the Jacksonville Intraocular Lens (IOL) manufacturing operation, ensuring that products, processes, equipment, test methods, facilities, utilities, software, and supporting systems are established and maintained in accordance with applicable Quality System and regulatory requirements. The role leads the Quality Engineering team supporting manufacturing operations and partners with Operations, Manufacturing Engineering, R&D, Validation, Quality Systems, Laboratories, Supply Chain, Supplier Quality, Facilities, EHS, Regulatory Affairs, and other functional organizations. The position provides leadership across product and process validation, risk management, nonconformance management, CAPA, change control, process monitoring, statistical methods, inspection and sampling...

The Senior Quality Engineer serves as a lead Quality Engineering contributor for the Jacksonville intraocular lens (IOL) manufacturing operation. The role provides hands-on quality oversight and advanced technical support for startup, technology transfer, qualification, validation, regulatory readiness, commercialization, and sustained manufacturing of Class III IOL products. The position partners with Operations, Manufacturing Engineering, Validation, Quality Systems, QC Laboratories, Supplier Quality, R&D, Regulatory Affairs, Facilities, EHS, IT, and Supply Chain to ensure that products, processes, equipment, software, test methods, utilities, and supporting systems are compliant, capable, and inspection ready. The Senior Quality Engineer applies advanced quality engineering, statistical, risk management, investigation,...

Responsible for leading and coordinating the day-to-day operations of the Jacksonville IOL Quality Control, Quality Inspection, Testing, and Product Release functions. The position ensures timely and compliant incoming inspection, in-process inspection and testing, finished-product testing, batch/lot record review, disposition, and release of IOL products in accordance with approved procedures, production schedules, Johnson & Johnson policies, and applicable regulatory requirements. The IOL Quality Control Senior Supervisor provides technical and people leadership across analytical, physical, optical, dimensional, and visual inspection activities. Responsibilities include test method transfer, verification and validation; First Article Inspection (FAI); laboratory equipment qualification and lifecycle management; data integrity; OOS/OOT...

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

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Manager, Quality Assurance at Gilead you will report to the Associate Director, Quality Assurance within the PDM External Quality...

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...

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 in applying program requirements. Reviews and approves all supplied product drawings and component quality plans. Manages development of...

INTERN/Global Patient Safety (Summer 2027) What You Will Do During this program, you will work with the Late-Stage Oncology Clinical Science team to support the execution of oncology clinical trials. You will gain hands-on experience in clinical data review, study conduct, and cross-functional collaboration while contributing to activities that support the development of innovative therapies for patients with cancer. The key responsibilities · Support clinical development of oncology compounds and assist with day-to-day execution of clinical trials, focusing on data quality. · Participate in cross-functional discussions involving clinical, statistics, operations, and data management teams. · Support clinical trial operations...

That’s what makes us Roche. As a Quality Control Analyst I in our Bioassay US Testing Group, you will play an essential role in advancing clinical and commercial therapeutics. Our team is committed to high-quality science and collaboration, delivering critical testing that directly impacts patient lives. This role offers an engaging, hands-on laboratory environment with continuous opportunities to develop your technical and analytical expertise in biopharmaceuticals. You perform biochemical and immunological cell-based and non-cell-based assays to support clinical and commercial products. You support critical operations including process development, product characterization, stability studies, in-process testing, and lot release testing within...

The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics products to patients, including mAb, ADC and cell & gene therapies. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic...

The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics products to patients, including mAb, ADC and cell & gene therapies. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic...

The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant. Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned...

DePuy Synthes is recruiting for a Technology Mgr, Quality Systems, Analyst , located in Raynham, MA or West Chester, PA or New Brunswick, NJ or Palm Beach Gardens, FL or Warsaw, IN. The Technology Manager, Quality Systems, Analyst leads the technology capability supporting DePuy Synthes enterprise quality systems within the Supply Chain Technology function, Quality sub-function. This role manages a team of individual contributors and/or supervisors and is accountable for effective performance management, capability building, and career development. The Manager develops tactical and operational plans for the quality systems portfolio, owns and executes the product roadmap across complaint handling, CAPA,...

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

DePuy Synthes is recruiting for a Tech Professional, Quality Systems, AI , located in Raynham, MA or West Chester, PA or New Brunswick, NJ or Palm Beach Gardens, FL or Warsaw, IN. The Tech Professional, Quality Systems, AI is a seasoned individual contributor within the Supply Chain Technology function, Quality sub-function, accountable for the support, enhancement, and AI-enabled modernization of the enterprise quality systems landscape at DePuy Synthes. Establishing methods based on proven research, this role provides day-to-day technical support and continuous improvement across validated quality platforms — including complaint handling, CAPA, nonconformance, document management, training, and audit systems —...

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. MAIN PURPOSE OF THIS ROLE We are seeking a highly qualified Quality Assurance Lead Specialist in Sylmar, CA to conduct quality-related activities to deliver consistent, high quality documents, services, products and processes. Ensure compliance...

QUALITY CONTROL TEAM LEAD – 2ND SHIFT What you will do In this vital role you perform testing and assist with managing the Quality Control Bioassay laboratory. The Specialist, Quality Control Bioassay will report directly to the Senior Manager of Quality Control Bioassay. This role may manage bioassay staff. Under minimal supervision, the successful candidate will support the QC organization by Assisting with planning and execution of equipment installation and qualification within the Bioassay lab to support startup. Responsible for operating QC bioassay analytical testing for biologic products which includes ELISA and cell-based methods. Leading transfer, qualification, and/or validation...

SR ASSOCIATE QUALITY CONTROL I What you will do In this vital role you perform testing and assist with managing the Quality Control Bioassay laboratory. The Specialist, Quality Control Bioassay will report directly to the Senior Manager of Quality Control Bioassay. This role may manage bioassay staff. Under minimal supervision, the successful candidate will support the QC organization by Assisting with planning and execution of equipment installation and qualification within the Bioassay lab to support startup. Responsible for operating QC bioassay analytical testing for biologic products which includes ELISA and cell-based methods. Leading transfer, qualification, and/or validation for the...

SR ASSOCIATE QUALITY ASSURANCE - PQA – NIGHT SHIFT What you will do In this vital role you will be the Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events,...

We are searching for the best talent for Senior Counsel, Regulatory Law, MedTech. The Johnson & Johnson Global Legal Organization (“GLO”) is recruiting for a Senior Counsel, Regulatory Law, MedTech to support Johnson & Johnson MedTech. This position can be based in Washington, D.C., Santa Clara, California, New Brunswick, New Jersey, or Raritan, New Jersey. This Senior Counsel position is for a regulatory attorney within the Med Tech Legal Team of the GLO. The responsibilities of this Senior Counsel involve providing strategic legal counsel on a wide range of regulatory and compliance issues to support the development and commercialization of...

Purpose Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports. Requires knowledge and technical expertise of Microbiology, regulatory requirements and Global TrackWise system. Responsibilities Responsible for microbiology lab investigations. Extensive knowledge of Global TrackWise System and lab procedures, processes and methods. Performs, coordinates and supports method validations and prepares final reports documenting the validation findings. Receives and interprets the results of bioburden, microbial limits, environmental monitoring, growth promotion testing and sterility testing. Investigates all out-of-limit conditions and with the direct support from the QC Lab Manager implement a corrective...

Responsible for supporting quality system integration activities for the Medical Device and Combination product business. This role will support the strategic direction to ensure business objectives are met to support and sustain the Combination Products and medical devices. Complete quality assurance activities to develop, implement, and sustain required device regulations to comply with global medical device and Combination Product Regulations and assure proper integration and support of device regulations. Areas of direct responsibility include development of Quality Assurance policies and procedures for medical devices and Combination Product regulations that support the AbbVie business objectives, functional area strategies, and the...

Purpose The Associate Director, Customs Valuation Compliance & Reporting, is a critical compliance role that actively partners across the enterprise and leads the operations and strategic design of the end-to-end customs valuation and reconciliation process. Responsibilities include leading the financial planning and reporting of customs tariff impact to AbbVie’s imports (primarily focused on the Americas region) by conducting relevant variance analyses, scenario modeling and developing executive-ready reports; leading customs valuation initiatives in collaboration with stakeholders from other departments; and ensuring accuracy and predictability of tariff costs and other customs reporting metrics. Responsibilities Ensure compliance with U.S. Customs and Border Protection...

Purpose The Validation Engineer supports the development and maintenance of validation activities for facilities, utilities, equipment, systems, processes, cleaning processes, and laboratory instruments in accordance with company standards, health authority regulations, cGMP, and site procedures. Under the direction of the Validation Section Manager and guidance from senior validation personnel, this individual executes assigned validation activities, prepares and reviews validation documentation, supports routine requalification activities, and helps maintain the validated state of systems at the plant. This role applies established procedures, escalates issues appropriately, and develops validation knowledge while contributing to the effectiveness of the Quality System. Responsibilities Main responsibilities...

Abbott Core Diagnostics is seeking a Contract Compliance & Audit Analyst who will be responsible for ensuring integrity, accuracy, and compliance of customer contract data and pricing programs within Model N and related commercial systems. This role serves as the primary owner of contract audit activities, supports Corporate and internal audit requests, administers freight and shipping configurations, and manages no-charge product processes in accordance with Abbott policies and Office of Ethics & Compliance (OEC) requirements. The Analyst works cross-functionally with Contracting & Pricing, Finance, Customer Service, Sales, Operations, Legal, and Compliance to maintain contract accuracy, support audit readiness, and ensure...

Johnson & Johnson is currently recruiting for a Data Quality & Automation Specialist to to be based in Raritan, NJ. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. About MedTech Fueled by innovation at the intersection of biology...

DePuy Synthes is recruiting for a Director, Analytics & Compliance, located in Raynham, MA, Raritan, NJ, and West Chester, PA The Director, Analytics & Compliance will own the end-to-end strategy, operating model, and measurable outcomes for analytics-enabled compliance, risk monitoring, and enterprise financial reporting across DePuy Synthes. This leader will translate business, Finance, Legal, Compliance, Quality, IT, and operational priorities into scalable analytics products, SAP-fed financial reporting solutions, data controls, AI-enabled capabilities, and action-oriented monitoring processes that improve decision quality, risk coverage, productivity, auditability, and business performance. The role is accountable for moving analytics beyond reporting by ensuring that insights,...

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 Manager, Cross-Regional Operations & Strategic Support Regional Regulatory Affairs to be located in Raritan, NJ; Titusville, NJ; Horsham, PA; or Spring House, PA for a duration of about 13 months. Candidates...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer - Immunology to be based in Horsham, PA. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Purpose The Senior Manager, Health Care Compliance Officer serves as a strategic healthcare compliance partner to...

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 Manager, Quality Systems to be located in Añasco, PR. Purpose Lead the design, implementation, maintenance, and continuous improvement of the site Quality Management System (QMS) to ensure compliance with applicable regulations and corporate quality standards. Act as a subject matter expert for Quality Systems across development, manufacturing, and supply chain activities, enabling product...

About This Role As the Associate Director of Device Regulatory Affairs, you will be at the forefront of leading regulatory strategies and execution for Class III medical device submissions across the United States, European Union, and United Kingdom. You will manage a team of 2 global regulatory affairs staff, ensuring that all regulatory plans, submission content, and approval strategies are meticulously developed and aligned with high-risk device programs. Your role is pivotal in serving as a senior regulatory representative in interactions with key health authorities, including FDA, EU notified bodies, and UK approved bodies, to ensure timely and compliant responses....

The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of Cell & Gene Therapies. This position is hybrid, and may be based in Santa Monica, CA, Gaithersburg, MD or Boston, MA and reports to the Senior Director, CMC-CGT Regulatory Affairs. Essential Functions and Responsibilities Interpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams. Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC component(s) of IND / IMPD / BLA/ Master Files, amendments,...

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

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Manager, Environmental Health, Safety & Sustainability (EHSS) Environmental Compliance is responsible for leading the implementation, oversight, and continuous improvement of...

The Associate Director, Quality Control - Biologics QC Lead provides strategic Quality Control leadership for assigned biologics programs across the product lifecycle. The role serves as the primary QC representative and partners with internal and external stakeholders such as Analytical Development, Quality Assurance, Regulatory Affairs. The Associate Director establishes phase-appropriate QC and analytical strategies that enable clinical development, technology transfer, process validation, regulatory submission, commercialization, and lifecycle management while ensuring scientifically sound, compliant, and executable control strategies. Job Responsibilities Serve as the QC Lead and primary Quality Control point of contact for assigned biologics programs; represent QC on product teams...

Associate Quality Control HPLC/CE What you will do The Associate Quality Control will support the QC analytical chemistry team by performing testing HPLC/UHPLC (high and ultra-high liquid chromatography), titer, CE (capillary electrophoresis), CEX (cation exchange), HILIC (hydrophilic interaction). This role may also perform additional testing such as TOC (total organic carbon), LAL (endotoxin testing), protein concentration, appearance and pH. Under general supervision, this position is responsible for performing analytical testing and support in the HPLC/Capillary Electrophoresis (CE) group in Clinical Quality Control. Responsibilities include Responsible for one or more of the following activities in QC analytical testing, sample and...

Ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distributing of products through formal QA Audits, investigations, training, and recommendations to improve processes / procedures. Evaluate and provide QA recommendations on all products, systems, and issues that are affected or may be affected by regulatory or cGMP requirements. This is a 1st shift position Sun-Thurs or Tues-Sat with the option for off shift depending on business needs We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent...

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

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

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

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

MANAGER QUALITY ASSURANCE – PQA What you will do In this vital role you will be the Manager Quality Assurance for the PQA team and will work directly with plant manufacturing and engineering staff during the Amgen North Carolina (ANC) facility startup and transition to on-going bulk drug substance manufacturing, including development, clinical, launch and commercial operations. The Manager Quality Assurance will hire, train, develop, and manage Quality Assurance professionals to successfully deliver on role to support (Good Manufacturing Practices) GMP Manufacturing and to oversee and manage change in an effective, efficient and compliant manner. This includes partnership with...

Regulatory Affairs Manager - CMC What you will do In this vital role you will be responsible for the strategy and execution of the site-specific aspects of the preparation of CMC post-market supplements and facility registrations. You will interface with site functions to coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity and provide impact assessments for deviation with input from the CMC Product teams and the CMC Region representative. You will serve as Regulatory CMC voice for product teams by providing the following services Define minimum regulatory filing requirements...

Regulatory Affairs Manager - US Regulatory Lead, Rare Disease What you will do The Regulatory Affairs Manager at Amgen ensures the company’s compliance with all regulations and laws pertaining to the company’s business. They work with federal, state, and local regulatory agencies on issues and regulations that affect the company’s products and services. In this vital role you will be assigned to one or more Amgen products, and plan and execute the Regulatory strategies for that product(s) in their country(ies). Specific responsibilities include but are not limited to Support the Global Regulatory Team (GRT) in US Regulatory Activities (e.g....

SR ASSOCIATE QUALITY ASSURANCE I – PQA – 2ND SHIFT What you will do In this vital role you will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance. * Staff for the PQA...

Position Overview The Senior Specialist, Clinical Supplies Quality, Global Development Quality is responsible for support of the Clinical Supply Chain for clinical development programs for our company's portfolio, specifically in terms of assuring the reliable availability, quality and regulatory compliance of clinical supplies produced. This position will have responsibility for support of US quality operations and disposition, global distribution planning and management, and acquisition integration. Primary Activities This position will require an in-depth close collaboration with the key stakeholder groups including Global Clinical Supplies, Global Development Quality, Regulatory Affairs, Device Development & Technology, and External Development & Manufacturing, and Global...

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. As Vertex continues to grow, we are accelerating capabilities in technology and data to remain at the forefront of science, medicine, and technology. The Data & Technology Engineering, Biopharmaceutical Science, Manufacturing, Supply & Quality organization is focused on improving patients’ lives through AI, data, and technology innovation. The Senior Director, Quality AI, Data & Technology Engineering will define and execute the strategic vision for transforming Vertex’s global Quality operations through AI, data, and technology. This leader will champion AI-driven approaches...

This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division. 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. Supplier Quality Enginee r II drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You’ll Work On Assess potential new suppliers for technical, quality and...

Senior Manager Quality Compliance This position works out of our Plymouth, MN location in the Electrophysiology division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies, allowing people to restore their health and get on with their lives. As the Senior Manager Quality Compliance , you’ll provide leadership for quality system compliance initiatives, audit readiness, regulatory change management, field actions, and quality compliance strategy across the EP business. This role leads teams and collaborates across functions to strengthen compliance capabilities, support inspections and audits, and drive continuous improvement What You’ll Work On Lead quality compliance...

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...

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...

Senior Specialist Quality Assurance Abbott Point of Care is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective. We have an opportunity for the role of Senior Specialist Quality Assurance within our Abbott Point of Care (APOC) team, based at our Princeton, NJ headquarters . Working under broad supervision, manages the day-to-day compliance with applicable domestic and international regulations and activities related to complaint handling and Medical Device Report (MDR) submissions. Ensures that complaints are reviewed within established timeframes. Responsible for filing Medical Device Reports to...

Are you ready to steer global CMC strategy for cell and gene therapies that redefine what’s possible for patients? This role positions you at the center of breakthrough programs, where your regulatory leadership translates pioneering science into high-quality submissions and decisive health authority interactions that accelerate access for people who need it most. As a Director Regualtory Affairs CMC you will shape end-to-end CMC regulatory pathways across development stages, partnering closely with technical, clinical, and quality leaders. You will you apply your expertise to anticipate risk, set clear direction, and drive rapid, global approvals for a growing pipeline. This postion...

This role ensures the safety, sterility, and compliance of raw materials, in-process samples, and final products through environmental monitoring, microbial testing, and aseptic processing support. The role focuses on learning and performing routine activities with high quality and data integrity, assisting with lab maintenance and inventory, and supporting QC operations to meet timelines. The position plays a critical role in maintaining regulatory compliance and ensuring product quality for clinical and commercial manufacturing. Role Responsibilities Complete Environmental Monitoring sampling in various classification suites within the GMP Space (non-viable and viable air sampling, Surface Viable sampling). Ability to be gown...

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

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

This position schedule is Monday-Friday business hours, with occasional weekends and holidays as needed for coverage About This Role The Quality Control Materials Associate II plays a critical role in supporting the release of raw materials and utility systems used in Biogen manufacturing operations. In this position, you will perform raw material sampling, inspections, testing, utility monitoring, and validation activities while ensuring compliance with GMP and GLP requirements. Working closely with Quality Control leadership, Manufacturing, Quality, and cross-functional partners, you will help maintain the integrity and accuracy of laboratory data that directly impacts material release decisions. Success in this role...

The function of this position is to perform microbiological testing and related analytical functions in the QC microbiology lab. This position includes performing microbiological and other testing following approved methodology to assure that the safety, quality, purity and stability (as appropriate) of our systems products, components and in- process stages are in compliance with approved specifications. Additionally, this position provides input for data trending and assists with or authors periodic reports as necessary, highlights problems related to technical and equipment issues, and works closely with the Microbiology Manager. The microbiology team is highly flexible and provides cross functional support as...

Use Your Power for Purpose The Quality Control Analytical group is seeking a highly motivated candidate to support GMP sampling and analytical testing of raw materials at the Andover site. The candidate will perform sampling, testing, and support activities for raw materials, attend meetings, and participate in continuous improvement activities What You Will Achieve In this role, you will Perform Raw Material Sampling in the GMP warehouse to support clinical and commercial manufacturing operations Perform Daily Sanitization of ISO classified Sampling Areas Perform and Review Appearance, Gas, and Raman Spectroscopy testing on Raw Materials. Participate in continuous improvement culture within...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Manager, CSV Cell Therapy supports the successful implementation and support of manufacturing and laboratory equipment and computerized systems at...

Own the lifecycle management, validation, and sustained operation of digital quality systems and related capabilities. Serve as the Quality subject-matter expert and system owner for digital quality technologies, ensuring solutions are compliant, fit for purpose, inspection-ready, and aligned with cGMP, data integrity, and electronic records/electronic signatures requirements. Responsibilities Lead Quality ownership of digital quality systems, including implementation, enhancement, lifecycle management, and operational support for quality-related capabilities. Act as the Quality system subject-matter expert, translating business, cGMP, data integrity, and electronic records/electronic signatures requirements into clear system requirements and operational controls. Partner with Quality, Manufacturing, IT, Engineering, Validation, and other stakeholders...

The Senior Manager, Regulatory Strategic Planning , is responsible for successfully delivering project management capabilities for cross-functional teams of medium- to high-complexity within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business processes to properly drive the execution of AbbVie’s regulatory strategies. The Senior Manager will be developing and managing the schedules, activities, and deliverables for the Global Regulatory Product Teams (GRPTs), interacting with key stakeholders, and leading process improvement efforts to help achieve business performance goals for regulatory compliance and productivity. Responsibilities Provides project management leadership in support of GRPTs; develops schedules and...

Reporting to the Director, MHI Compliance and Independent Education, External Interactions, the Senior Manager, is accountable for compliance monitoring supporting effective implementation of standards governing external interactions and field medical activities. In accordance with the principles for maintaining a high-quality compliance program, the Senior Manager will implement written procedures and monitoring to support compliant field medical activities. This role will contribute to effective training, conduct monitoring/auditing and recommend and implement corrective and preventive actions. Primary areas of responsibility will include field engagement and documentation standards. This role is responsible for building positive and collaborative relationships in matrixed and cross-functional team...

The Associate Director, Regulatory Data Quality will be responsible for implementing and operationalizing data quality stewardship capabilities across Regulatory Affairs. The role will translate data governance strategies, standards and frameworks into practical ways of working that improve the quality, integrity, consistency and usability of regulatory data. Regulatory data is a core asset for regulatory affairs and the broader enterprise at Gilead, this leader will ensure data integrity and quality expectations are embedded into the ways of working within the organization. This role ensures compliance with global regulatory data requirements, drives data quality initiatives, and facilitates alignment between global regulatory affairs...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Summary Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required. Performs...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team...

As Senior Director, Regulatory Affairs Management for the Infectious Disease Unit, you will lead and develop the Regulatory Affairs Management team and set the strategic direction for regulatory delivery across the Infectious Disease portfolios. As a member of the ID Regulatory Affairs Leadership Team, you will partner with Regulatory Affairs colleagues globally to ensure high-quality, compliant submission delivery, strengthen organizational capability, and advance continuous improvement. Accountabilities Oversee regulatory project management and operational delivery for development-stage and approved products across the global Infectious Disease portfolio Lead and develop the Infectious Disease Regulatory Affairs Management team through direct and indirect people leadership,...

AstraZeneca - Infectious Diseases At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of people, where the burden of disease is greatest. During the COVID-19 pandemic, we played an important role as part of a truly global effort to respond to a new and unprecedented challenge. We will continue to advance science in infectious disease therapies and work with partners to drive improvements in public health and ensure our science reaches millions more people. Role The Senior Regulatory Affairs Director (SRAD) leads the global regulatory strategy for complex products. They aim...

Role Overview The Associate Director, Digital Engagement Partner is responsible for driving the adoption, engagement, governance, and business value realization of digital capabilities across the Global Regulatory Affairs and Clinical Safety (GRACS) organization. This role serves as a strategic partner to business stakeholders, helping identify opportunities, shape digital strategies, and deliver measurable business outcomes through the integration of artificial intelligence, data science, automation, Power Platform solutions, and other emerging technologies. The position acts as the primary liaison between business functions, technology organizations, and global stakeholders to accelerate awareness, adoption, and value realization of digital capabilities. The role leads engagement strategies,...

Position Overview Quality Lead, Director– QMS & Digital Quality Governance Analytical Global Quality Management Systems The Global Quality Group within our Company Manufacturing Division is seeking an experienced transformation lead in the capacity of Director– Quality Management Systems (QMS) & Digital Quality Governance, to provide strategic and operational leadership for the QMS workstream within a complex, enterprise-level laboratory transformation program. This role is accountable for architecting, modernizing, and deploying a modernized, digitized Quality Management System tailored to support next-generation QC testing, end-to-end analytical digitization, instrumentation innovation, and laboratory automation. The QMS Quality Lead will oversee the harmonization and evolution of...

The Individual Contributor Director is responsible for the review and approval of US promotional materials and serving as the promotional regulatory expert with legal, medical and commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, our Company's policies, and support business objectives. Functions at an advanced and independent level. Serve as the liaison and manage correspondence with FDA’s promotional review divisions OPDP/APLB, including complex regulatory questions and submissions for advisory comment. Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk. Proactively partners with the review...

The Digital and Data Quality (DDQ) Director will lead the respective DDQ organization and be responsible for the management of all quality aspects of GMP computerized systems utilized by our Company Manufacturing Division, including but not limited to IT applications Automated manufacturing and packaging equipment Automated laboratory systems Data analysis tools Emerging and innovative technologies The DDQ Director is responsible for ensuring compliance with company policies, procedures, and regulatory expectations across assigned areas. This includes oversight of all quality-related activities for Computerized systems supporting site and above-site GMP processes Systems required by our Company Manufacturing Division Quality Manual Systems with...

The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities, and supports new/existing project initiatives. Key Duties and Responsibilities Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified. Supports change control assessments, implementation and closure Identifies and facilitates continuous improvement efforts Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed Helps represents Vertex Quality on cross-functional working teams, applying strong communication...

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

Sr Associate Supply Chain Compliance What you will do In this vital role you will serve as a key compliance partner within the US and LACAN Supply Chain, safeguarding product quality and patient trust through the effective implementation of GDP requirements, quality systems, and regulatory standards. Lead critical quality processes, identify and mitigate risks, and drive operational excellence across the distribution network. Specific responsibilities include but are not limited to Own and manage temperature assessment records. Own and manage minor and major deviation records and lead root cause analysis sessions. Own and manage CAPA and CAPA EV records, ensuring...

Build our future together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager to join our Patient Safety team. The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the assigned Therapeutic Area. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients...

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

We anticipate the application window for this opening will close on - 16 Nov 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Senior Supplier Quality Engineer will support...

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives. Main Responsibilities Supporting the implementation and maintenance of the complaint (Third Party/Product Technical) management process Assisting...

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. “We are seeking an experienced, high caliber Data Scientist, I for our Sylmar, CA . Responsible for ensuring the requirements for Device/Combination Products through the execution of Abbott standard operating procedure and Product Lifecycle...

Technical Program Manager - Quality Systems This position works out of our Columbus, OH in the Nutrition Division . This role within Abbott Nutrition’s Global Engineering, Manufacturing Technology & Innovation (MT&I) team leads the global governance, strategic direction, and continuous improvement of enterprise Quality Management System (QMS) programs supporting Abbott Nutrition's manufacturing, engineering, and innovation network. The Technical Program Manager - Quality Systems is responsible for ensuring the effectiveness, sustainability, and regulatory compliance of technical (Buildings, Facilities, and Utilities and Equipment) Quality System (QS) elements while aligning quality strategies with engineering requirements and business objectives. This role serves...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent as Associate Director, Compliance Operations Metrics & Analytics. Purpose The Associate Director, Compliance Operations Metrics & Analytics , is a key business leader in delivering operational excellence across the Innovative Medicine Regulatory...

Division Leverage Services – Global Regulatory Services Location Santa Clara, CA, Sylmar, CA, Temecula, CA, or St Paul, MN The Senior Regulatory Project Management Specialist will play a critical role in driving the successful execution of business-critical global regulatory initiatives across Abbott's medical device portfolio. Working in close partnership with cross-functional teams, the international regulatory affairs organization, and business unit stakeholders, this role will help coordinate and manage complex projects supporting regulatory submissions and product registrations in key global markets. This position serves as a central point of coordination for project planning, execution, monitoring, and reporting, ensuring that...

AbbVie’s Global Internal Audit function plays a critical role in protecting and enhancing the organization’s value through risk-based assurance and advisory services to internal stakeholders, senior management, and our Audit Committee of the Board. Internal Audit strives to be a critical function to evaluate company, industry and emerging risks, effectively partnering with the business, and consistently recruit and develop key talent. Our goals are carried-out through the talent of the audit team, while leveraging analytical and audit tools, supported by a dynamic and collaborative team culture. The scope of compliance audits conducted by the Senior Auditor, Compliance Internal Audit may...

Purpose The Office of Ethics and Compliance (OEC) Strategic Execution and Initiatives Senior Analyst will be responsible for project management and execution of strategic initiatives advancing the global OEC program, including (1) assessing OEC support needs, and planning and executing risk-directed projects, including project plans, stakeholder engagement, communications/training, risk-focused information sharing, notes, and supporting the draft, coordination, and finalization of critical compliance reporting materials (e.g., Risk Assessment) to support execution of identified projects; (3) capturing OEC accomplishments and socializing for awareness against Strategic Initiatives, Powering What’s Next and other OEC or AbbVie priorities; (4) leading the management of OEC resources...

Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi's Framingham Biologics facilities. QA's main responsibility is to ensure cGMPs are adhered to during manufacturing operations. Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality and efficacy of Sanofi's Products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company's business and global markets. Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help...

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. The Global Head, Regulatory Science — Model-Enabled Development, Real World Evidence & Novel Endpoints serves as a specialized center of excellence within Sanofi's Regulatory framework, driving innovation in regulatory science through advanced model-informed approaches, real world evidence and novel endpoint development. We accelerate drug development timelines by providing expert guidance on Model-Enabled Drug Development frameworks, regulatory validation of new endpoints, real-world evidence data and cutting-edge regulatory strategies across therapeutic areas. We bridge...

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

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...

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Lead Engineer, IT Compliance, Data Integrity is an individual contributor within the Cell Therapy Information Technology organization supporting Bristol...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Sr. Engineer, IT Compliance works cross-functionally to lead compliance-related activities for GxP electronic systems and applications. This role is primarily...

We are searching for the best talent for a Staff Quality Systems Engineer to lead and optimize CAPA and Nonconformance (NC) processes within a regulated medical device environment. This role will be based in Danvers, MA. Purpose This role is instrumental in driving quality system improvements, ensuring global regulatory compliance, and mentoring junior engineers. The position includes travel to support cross-site initiatives, supplier quality activities, and audit readiness. You will be responsible for Lead complex investigations of product and process nonconformances using advanced root cause analysis methodologies (e.g., Fault Tree Analysis, 5 Whys, Fishbone, DOE). Oversee the end-to-end CAPA and...

Standard Operating Procedure management core responsibilities include Creating and formatting SOPs, Work Instructions (WIs), Setup Sheets, Flowcharts, Forms and Job Aids. Maintaining SOPs, Setup Sheets, Flowcharts, Forms and Job Aids in electronic repository and/or applicable electronic Quality Management System (eQMS). Managing and tracking Review and Approval Processes within electronic repository and/or applicable electronic Quality Management System (eQMS). Managing weekly distribution of SOPs, Flowcharts, Job Aids and updated Table of Contents to departmental area libraries. Managing distribution of setup sheets to packaging lines. Maintaining the Central SOP/Setup Sheet and Flowchart hard copy Libraries – current and archived. Managing documents per...

Position Overview The Quality Specialist supports the Micro Sterility Assurance Laboratory by providing quality and compliance oversight for sterility assurance testing activities. This role ensures laboratory operations are conducted in accordance with GMP requirements, approved SOPs, and company quality standards. The incumbent will support routine and non-routine Micro Sterility Assurance testing activities, review documentation for accuracy and completeness, and partner with laboratory and quality teams to drive continuous improvement. In addition, this position will support process improvement initiatives through MPS, helping identify opportunities to improve efficiency, compliance, and operational performance. The Quality Specialist is expected to maintain a strong understanding...

2027 Summer Intern - External Quality (PTQX) Department Summary External Quality is responsible for the Quality and Compliance of externally sourced raw materials, supply from CDMOs, and distribution quality from Roche sites to Affiliates, including the certification for the EU market. We serve our patients through external partnerships because access to quality products is every patient’s right, as well we leverage external partners to offer flexibility to our internal capacity at the correct cost and quality, we enable our external partners to reliably deliver compliant, quality products to our supply chain customers so that we can deliver to patients worldwide,...

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...

At AstraZeneca Wilmington , we are seeking a PRA Director (Promotional Regulatory Affairs Director) to join our Promotional Regulatory Affairs team. This is a strategic, high-impact role designed for a professional with deep expertise in FDA promotional regulations , capable of delivering expert regulatory guidance across assigned brands and key business areas. As PRA Director , you will work independently with cross-functional teams, providing risk assessments, strategic advice, and leadership in the review of promotional materials through the MLR (Medical, Legal, Regulatory) Approval Process . Key Responsibilities Efficient review and risk assessment of all promotional materials across various segments and...

Are you ready to steer US promotional regulatory strategy in a way that accelerates responsible growth and earns patient and prescriber trust? This role translates science into clear, compliant communication across healthcare professionals, consumers, and payers—so that what we say is as strong as the medicines we deliver. As Director of Promotional Regulatory Affairs, you will set the regulatory guardrails that enable confident brand execution and speed. You will partner closely with Medical, Legal, Commercial, and Corporate Affairs to shape claims early, guide labeling implications, and ensure promotional materials meet the highest standards across all channels—from print and broadcast to...

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...

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team...

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

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

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

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

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

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

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...

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

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

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

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

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

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

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

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

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

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

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. PRINCIPAL OBJECTIVE OF THE POSITION The Senior Specialist, Validation Engineer II supports the successful implementation of manufacturing, and laboratory equipment...

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

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

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

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

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

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

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

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Commercial Analytical Science (CAS) team within the Quality Control Strategy and Science (QCSAS) department is embedding AI into its...

We anticipate the application window for this opening will close on - 14 Nov 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we bring bold ideas forward...

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

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

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

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

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

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

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

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

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

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

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Quality & Validation (Q&V) department is the Quality Unit that reviews and approves validation lifecycle documents, procedures, and technical reports related to (1) facilities, equipment, utilities, (2) cleaning, (3) processes, (4) analytical methods, (5) requalification, (6) sterilization, (7) transport, and (8) computer systems. Q&V provides leadership, direction, and oversight...

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

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

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

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

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

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

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

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

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

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Responsible for the registration of new products/line extensions/claims. Supports commercial activities while ensuring regulatory compliance and provides product development teams with...

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

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

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

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

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

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