Quality & Regulatory Jobs in Pharma & Biotech

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. This position supports the execution of routine testing in the Quality Control Microbiology laboratory while strictly adhering to site work instructions, Federal Regulations, cGMP, and Sanofi Pasteur policies and procedures. This position requires the individual to perform route testing as scheduled to support production, method validation as well as the stability program, and completing the required documentation. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and...

The Quality Assurance Department is responsible for providing oversight on all GMP activities and related functions associated with the manufacture and release of biological products at the site. The department manages the compliance program for the Framingham Biologics, Framingham Biosurgery and Northborough sites (e.g. Self Inspection, Dossier Compliance, External Inspections) and provides site metrics to determine site performance against Quality Metric Indicators. The department’s goal is to ensure that policies, procedures and processes are in place so that all site Quality Management System activities meet applicable regulations while allowing for monitoring the progress and the completion of Quality Compliance related...

The Associate Director in Global Clinical Supply (GCS) Compliance is a subject matter expert and project leader responsible for advancing and sustaining GxP Quality Systems across GCS to ensure clinical supply operations are executed in a compliant, inspection‑ready, and risk‑based manner. GCS supports Phase I–IV trials across 60+ countries in alignment with local and regional regulations for GxP (GMP, GDP, and GCP) and Environmental Health & Safety (EHS). In this role, the Associate Director applies deep technical judgment and systems level thinking to complex compliance challenges while influencing outcomes across a highly matrixed organization. This role provides expert support and...

The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation of the global regulatory strategy for CGT products of high complexity and visibility and may serve as Franchise GRL on complex programs with multiple indications. In addition to GRL responsibilities, the Sr RAD has the ability to function in dual capacity by also serving as a regional lead based on their location. The Sr RAD ensures that the regulatory strategy is designed to deliver efficient approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets...

Position Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am-6pm - Rotating 2-3-2 Panama Schedule) Manager Manager, Quality Assurance Shop Floor Note This position works a rotating 2-3-2 Panama schedule (6am to 6pm ), Day shift. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position will oversee and partner with operational areas to ensure GxP compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. In the capacity of QA Shop Floor, the Specialist shall serve...

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

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

The Senior Quality Engineer, Medical Device External Quality is part of AbbVie’s External and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality. The role will be based out of Lake County, IL site or Pleasanton, CA. This role primarily oversees external product quality assurance (EPQA) for commercial medical devices which are manufactured by third parties (TPM). In this capacity, the Manager, Medical Device External Quality, champions best practices related to sustaining supplier qualifications, product quality, equipment qualification, and manufacturing process validations. As such, the Manager, Medical Device External Quality works closely with AbbVie’s Contract...

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

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

We anticipate the application window for this opening will close on - 9 Jul 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...

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 Quality Technician III is a key support role within operations as part of the First Quality Response Team, responsible for rapid...

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

We anticipate the application window for this opening will close on - 13 Jul 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 - 9 Jul 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 - 6 Jul 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...

Objective / Purpose Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, leading and/or contributing with influence to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for other global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities The Senior...

About the role Perform Quality activities associated with cGMP biologics, intermediate, and/or drug substance manufactured at the Takeda Brooklyn Park Site. Focused primarily on providing support and guidance on complex and non-routine quality-related issues How you will contribute Follow all established, written procedures. Drive the assessment and implementation of global and local policies, guidance documents, standards, and procedures governing cGMP work performed at the site. Performs documentation review thoroughly, with a high attention to detail using extensive working knowledge of quality concepts and internal procedures and controls. Analyzes and interprets projects, studies, or investigations to determine next steps. Makes decisions...

Key Responsibilities Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management. This will involve collecting all the relevant inputs from the RBM framework (CORM) as well as R&D Quality Clinical Quality Assurance on audits and inspections. As part of the upstream protocol authoring process, partner with Drug Development, in particular the CORM function, to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors and ensure...

The Validation Associate Engineer will play a significant role in ensuring compliance with all regulatory requirements and industry standards related to GMP asset management and validation in a regulated GMP manufacturing facility. This position requires a hands-on individual with experience in GMP, an understanding of laboratory and/or manufacturing equipment, and strong technical writing and problem solving skills. Key Responsibilities Support the Periodic Review and Periodic Requalification program at BMS sites in Bothell, WA and Seattle, WA, including execution of requalification activities (temperature mapping studies), and development of Periodic Reviews. With oversight, generate validation protocols, specifications, reports, and qualification plans to...

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. Overarching Tasks It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will oversee...

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 At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to...

PRIMARY RESPONSIBILITIES ● Design, build, and automate quality analytics reports using business intelligence tools and databases to support performance monitoring. ● Gather and monitor production metrics, analyzing data sets to discover trends and develop actionable business insights. ● Generate recurring reports regarding team productivity and operational processes, including volume tracking and workload management. ● Manage technical workflows and documentation via Jira, including ticket management for analytics and relaying requirements between operations and engineering teams. ● Coordinate quality escalations, reviewing trends across issues such as process changes or panel state updates. ● Monitor compliance and quality records, including NCRs, CAPAs, amended...

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 marketing strategy...

The Senior Validation Engineer/Analyst functions as the lead for maintenance, engineering, and validation activities within the assigned site/area of responsibility. Equipment, facility, utilities and cleaning are within the scope of responsibility. The incumbent is the primary liaison with the Operations, engineering services, and third party vendors for executing activities within area of responsibility. All responsibilities should be executed in a manner to ensure that product quality is maintained at the appropriate level to meet R&D and Corporate Quality Standards/Expectations. Responsibilities Manage departmental capital projects and miscellaneous engineering activities. Work with in-house functional support and outside vendors to coordinate required services....

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

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

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

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 the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access to transformative...

About the role The Director, Clinical Program Quality & Excellence (CPQE) serves as a strategic quality leader supporting Takeda’s clinical development portfolio. This role is responsible for shaping and executing risk-based quality management strategies across assigned clinical programs, ensuring inspection readiness, regulatory compliance, and proactive quality oversight throughout the clinical trial lifecycle. You will partner closely with global cross-functional stakeholders, including Clinical Development, Study Execution Teams, Regulatory Affairs, and Quality organizations, to identify emerging risks, drive issue resolution, and strengthen quality performance across clinical programs. This position plays a critical role in supporting portfolio decision-making, safeguarding patient safety, ensuring data...

Johnson & Johnson is currently recruiting for a Manager Supplier Quality! This position will be located in Athens, GA 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 This role ensures business, quality and compliance goals adhere to Johnson and Johnson (J&J) policies, enterprise standards and government-issued...

The Sr. Quality Engineer, New Product Development, will be responsible for providing quality engineering support and leadership for New Product Development. Responsibilities Launch and stabilize new product launches through concept, design, development, and steady-state processes. Drives the development of product requirements, verification strategies, and validation strategies. Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction. Proactively engage partners to drive consensus and resolve issues in a timely fashion. Provide statistical support...

We are searching for the best talent for our Analyst, Preclinical Compliance & Safety position to be located in Spring House, 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 Preclinical Compliance & Safety Team develops, maintains, and delivers compliance strategies and programs supporting non-GXP...

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara, CA or Temecula, CA. In this role, you will support EU and US regulatory activities and collaborate with the global regulatory organization to maintain regulatory compliance for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease. The ideal candidate will possess strong analytical and project management skills, a working knowledge of medical device regulations, and the ability to interpret complex regulatory requirements and apply them to product development and lifecycle management activities. This role requires strong...

Senior Regulatory Affairs Specialist This position works out of our Itasca or Chicago, IL (Willis Towers) location in the Abbott Molecular Division . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business...

The Director, Global Patient Safety Individual Case Safety Report (ICSR) oversees global ICSR processing and external PV partners and vendors. This position manages the technical aspects of end-to-end safety case intake, processing, quality control, and regulatory submissions within a therapeutic area (as assigned) covering the applicable drug, biologic, medical device, and combination products, ensuring operations are consistent, compliant, and inspection-ready worldwide. The Director, Global Patient Safety Individual Case Safety Report (ICSR) plays a key role in global ICSR processing excellence and external business management. This position serves as a subject matter expert in pharmacovigilance (PV) and contributes to developing and...

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

The Sr. Director, Corporate Quality, Pharmacovigilance will be responsible for the management of GVP quality oversight, GVP-related audit program and for providing regulatory/GVP guidance. The Opportunity to Make a Difference This position will liaise with internal groups such as Pharmacovigilance Operations, Safety Evaluation & Risk Management, and Market Research, as well as external groups including contract auditors in an effort to ensure a high level of quality and consistency across the Sarepta platform; design and oversee the audit strategy; assist the GVP team in identifying and implementing corrective and preventive actions; and enable teams to be inspection ready, in support...

As Manager, Regulatory Quality, Vaccines at Pfizer, you will be at the forefront of innovation in vaccine development. Reporting to the Research & Development division, your work will directly contribute to improving patients' lives globally. Your efforts will ensure regulatory compliance and maintain the highest quality standards, ultimately leading to safer and more effective vaccines that protect individuals and communities. In this role, you will support and oversee multiple projects and ongoing work activities of moderate complexity within the department. You will operate in a highly cross-functional environment, partnering closely with stakeholders across Research & Development and Vaccines, to ensure...

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

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 Associate Director, International Regulatory Affairs Advertising & Promotion safeguards products and practices to adhere to the highest quality and regulatory standards. The Associate Director will be responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds. The Associate Director will interface with International Marketing, International Medical Affairs, Global Legal and Office of Ethics and Compliance with regard to advertising and promotion strategies and tactics intended for use globally. Responsibilities...

The Senior Manager, IT Quality is responsible for elevating AbbVie’s IT operations and software quality practices by ensuring full compliance with regulatory requirements and corporate standards, while providing advanced strategic leadership across process improvement, risk management, and validation strategies. This role leads to the development and implementation of quality systems and processes by leveraging digital enablement, data-driven methodologies, and emerging technologies including automation, AI, and advanced analytics. Collaborating directly with cross functional teams, the Senior Manager provides audit and inspection support, Corrective Action and Preventive Action execution in the Business Technology Solutions Quality area, and adoption of vendor documentation, strengthening...

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, IT Quality is responsible for elevating AbbVie’s IT operations and software quality practices by ensuring full compliance with regulatory requirements and corporate standards, while providing advanced strategic leadership across process improvement, risk management, and validation strategies. This role leads to the development and implementation of quality systems and processes by leveraging digital enablement, data-driven methodologies, and emerging technologies including automation, AI, and advanced analytics. Collaborating directly with cross functional teams, the Senior Manager provides audit and inspection support, Corrective Action and Preventive Action execution in the Business Technology Solutions Quality area, and adoption of vendor documentation, strengthening...

About the Role We are seeking a highly skilled Senior Manager to join our dynamic team supporting biologics regulatory submissions. In this role, you will serve as the lead author for key Module 3 Common Technical Document (CTD) sections. You will apply your analytical expertise and regulatory knowledge to deliver high-quality documentation in support of global regulatory submissions. You will be an integral member of cross-functional teams, collaborating closely with Quality Control, Quality Assurance, Regulatory, Analytical Research and Development, and Chemistry, Manufacturing and Controls (CMC) colleagues to deliver submissions to support commercial approval. The ideal candidate will have extensive analytical...

We are looking for a motivated and strategic regulatory professional to join our growing regulatory team at Relay Tx. You will contribute to the development and execution of innovative regulatory strategies to support the advancement of our transformative pipeline. You will support the global regulatory lead to drive regulatory planning and execution for our development programs. You will collaborate with cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA,NDA and MAA submissions. Your Role You will work closely with research and development colleagues to support the development and execution of innovative regulatory strategies for programs ranging from...

Job Title Process Quality Engineer This position works out of our St. Paul, MN (New Brighton) location in the Abbott Vascular division. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. What You’ll Do Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements Support the investigation, resolution and prevention of product and process nonconformances...

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 role will be based out of Amgen Rhode Island and will work under the guidance of the hiring manager. It is an administrative shift, Monday through Friday. The Raw Material Centralized Testing team provides analytical expertise in testing raw materials to meet Amgen specifications and ensure a constant supply of raw materials for Amgen products. The laboratory employs a variety of test methodologies from basic wet chemistry identifications...

Johnson & Johnson is seeking a Manager, Quality Systems to lead and enhance escalation and field action processes while ensuring full compliance with global regulatory and corporate requirements. This position can be located in Jacksonville, FL or Irvine, CA This role is responsible for establishing, maintaining, and optimizing escalation processes and field action systems. The Manager will ensure alignment with local, national, and international regulations, as well as Johnson & Johnson policies and procedures. Key Responsibilities Lead and manage Issue Escalation RMB and Quality Review Board (QRB) processes, including Coordinating information gathering across sites and stakeholders Preparing materials and...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Senior Software Design Quality Engineer role to be located at Danvers, MA. The Senior Software Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a key role in product risk management, cybersecurity, change controls, test reviews, and design controls. This engineer should excel in an environment...

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....

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

About This Role The Senior Manager, Quality Operations and Compliance (QOC), serves as a Functional Quality Representative (FQR) and plays a key role in advancing quality oversight and compliance across Research, Development & Medical (RD&M). This role supports the implementation of Biogen’s Quality Management System (QMS), focusing on Good Clinical Practice (GCP) and inspection readiness. The incumbent partners closely with clinical study teams, functional leaders, and vendor quality teams to manage quality issues, lead risk assessments, and ensure audit and inspection preparedness. This position also supports the identification and resolution of quality issues and the implementation of Corrective and Preventive...

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

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

The Regeneron Senior Manager, Global Development Quality Assurance, is a key position in the supervising, guiding and leading for one of the Good Clinical Practice (GCP) audit programs. Responsibilities include managing direct reports while supporting the development and execution of departmental mission, vision and goals. As part of the role of people manager, you will be responsible for staff development & training and resourcing direct reports. You will create strategic partnerships and implement risk-based quality auditing activities. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & where This...

Job Title Quality Engineer This position works out of our Houston, TX location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. THIS IS AN ONSITE DAILY REQUIRED POSITION. What You’ll Work On This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within manufacturing and during product manufacturing site transfer activities. MAIN RESPONSIBILITIES Identify and implement effective process control systems to support the qualification and on-going manufacturing of products in compliance with FDA 21 CFR Part 820/ISO 13485 requirements ...

Job Title Associate Quality Engineer This position works out of our Houston, TX location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. THIS IS AN ONSITE DAILY REQUIRED POSITION. What You’ll Work On This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within manufacturing, or system/services support. MAIN RESPONSIBILITIES This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within manufacturing, or system/services support. Identify and implement effective process control systems to support the...

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

DePuy Synthes is recruiting for a(n) Sr. Manager, Environmental Compliance, located in Raynham, MA or Warsaw, IN . 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) Raynham, MA (USA) - Requisition Number R-084501 Loughbeg, Ringaskiddy - Requisition Number R-085484 St. Anthony's Road, Leeds, UK - Requisition Number R-085485 Remember, whether you apply to one or all of these requisition...

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

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

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

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

The Patient Safety Associate Medical Director will provide medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development). This role will optimizes patient safety of Vertex products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe, through the effective and timely completion of Safety activities through the product life cycle. Key Duties and Responsibilities Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development) Responsible for the safety assessment activities of assigned products under the supervision...

United States Regulatory Strategy, Obesity and Related Conditions, Manager What you will do In this vital role you will. Amgen is seeking a United States Regulatory Lead (USRL) Manager supporting products in the Obesity and Related Conditions Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules. In this product-facing role, you will develop and execute U.S./regional regulatory strategy and tactics under general supervision, represent the region on global teams, and lead U.S. regulatory execution to enable clinical trials and maintain commercial licenses in compliance...

SENIOR ASSOCIATE REGULATORY AFFAIRS – CMC What you will do In this vital role you will facilitate product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen is searching for a Senior Associate to join the R egulatory O ptimization o f T echnical, S urveillance, and S trategic Support (ROOTS2) group within RA CMC. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and country. The RA CMC Senior Associate will interface with the Amgen...

U.S. Regulatory Strategy – Obesity and Related Conditions, Senior Manager What you will do In this vital role you will support products in the Obesity and Related Conditions Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules. This role requires demonstrated experience leading U.S. regulatory strategy and FDA interactions and may be performed within a global regulatory organization supporting U.S. regulatory responsibilities. In this product-facing role, you will develop and execute regulatory strategy in close partnership with the Global Regulatory Lead (GRL), serving as...

The Executive Director, Microbiology Quality Sterility Assurance (MQSA) is a pivotal global leadership role within BMS's Corporate Quality organization. This position brings critical expertise in sterility assurance, microbiological controls, and contamination control strategy across BMS's internal and external commercial and PD manufacturing sites — spanning pharmaceutical, biopharmaceutical, cell therapy and radiopharmaceuticals. This role is responsible for defining, owning, and governing BMS's enterprise-wide Contamination Control Strategy (CCS) as a living, risk-based framework — ensuring alignment with EU GMP Annex 1, FDA, and all applicable global regulatory standards. The Executive Director serves as the global Single Point of Contact (SPOC) for all...

We anticipate the application window for this opening will close on - 17 Jul 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...

DePuy Synthes is recruiting for a(n) Technology Mgr, Quality Systems, AI Lead located in Raritan, New Jersey, West Chester, Pennsylvania, Palm Beach Gardens, Florida, Raynham, Massachusetts, Warsaw, Indiana USA. This role plays a lead role in shaping the future of digital quality within Supply Chain Technology. This role leads the design and continuous improvement of quality systems, ensuring reliability, compliance, and scalability of technology platforms while embedding AI-driven innovation. You will directly impact product quality, operational excellence, and patient outcomes by strengthening quality management practices across systems, data, and processes. This is an exciting opportunity to influence enterprise-wide transformation at...

As Regulatory Strategist within our R&D team , you will be ready to shape the future of medicine. The race is on to speed up drug discovery and development to find answers for patients and their families, and your skills could be critical in helping our teams accelerate progress. As a key member of the Global Regulatory Team (GRT) and strategic partner to the Global Regulatory Lead (GRL), you will leverage your regulatory expertise to contribute to the definition of the global regulatory strategy and drive the execution of aligned US, EU, and/or global regulatory strategies for assigned projects, including...

Supplier Quality Engineer This position works out of our Scarborough, ME location in the Infectious Disease, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Supplier Quality Engineer will help drive supplier quality performance, continuous improvement, and risk mitigation across the supply base. Acts as a key technical contributor partnering across functions to ensure supplier capabilities meet product, regulatory, and business requirements. Leads supplier...

Quality Engineering Manager This position works out of our Altavista, VA location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Altavista, Va. , is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you...

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 patients with 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...

DePuy Synthes is recruiting for a Quality/Compliance Analyst located in New Brunswick, NJ or in Raynham, MA or West Chester, PA. Job Overview This role is responsible for executing and supporting regional operations in the areas of Document Management, Quality, Compliance, and SOX Reporting and for providing superior advisory and analytical support to internal and external customers enabling the compliant execution of critical customer focused operations. Key Responsibilities Day-to-Day Activities 70% Support and continually work within the parameters established by a risk-based Quality Management System framework. Serve as the Customer Service (CS) Subject Matter Expert (SME) regarding SOX financial...

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are currently seeking a Quality Director to join the Quality Team in Wilson, North Carolina. While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both...

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

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

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

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

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

The Senior Manager, Quality Assurance will be supporting the expanding site manufacturing and technology transfers into the medical device combination products modalities in La Verne, CA in alignment with PDM goals, have identified the need for experience and subject matter expertise within quality to support the medical device and combination product manufacturing. Specific Job Responsibilities Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements. Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews. Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed...

This position works out of our Abbott Park, IL location within the AQR Abbott Quality Regulatory division. The function of the Quality Program Manager is to provide leadership, oversight, and project management covering Abbott’s Quality Management System. This includes division / business support and quality expertise and consulting activities. The Quality Program Manager will support Divisions across all Abbott Quality Systems in activities associated with quality, regulatory compliance areas. The candidate will provide strategic, technical, and business support across all Quality Management Systems by interacting directly with Divisions and providing quality and technical expertise and strategic consulting activities for the...

In GBS we dare to change the way we work—being brave, resilient, and focused on simplifying how we deliver value. Through our global scale and diverse services, we drive outcomes with innovation and expertise. This requires a team that sees no boundaries, collaborates across functions, challenges the norm, and feels empowered, motivated, and engaged. The Senior Director, Compliance and Legal Services will lead the global build-out and maturation of a cohesive service portfolio spanning Compliance, Privacy, Legal Operations, and eDiscovery within GBS. Reporting to the Head of GBS Operations & Enabling Functions Services, this role supports strategy build, is the...

About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Monitors designated systems and activities, according to tasks trained and assigned, to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities—including small molecules, biologics, and external manufacturing sites—the role employs an agile approach to drive standardization, scalability, and sustainability. This position leverages ICH Q12 principles to streamline...

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

As Principal Compliance Engineer within our R&D team , you will play a key role in ensuring the timely and thorough execution of investigations to ensure clinical batches are best positioned for release. This position is critical to maintaining the highest standards of quality and compliance in our clinical manufacturing operations, directly supporting the development of life-changing medicines for patients worldwide. In this role, you will lead and contribute to cross-functional investigations, implement corrective and preventative actions (CAPAs) based on investigational conclusions, apply Lean methodologies to drive operational efficiency, and create and present quality event tracking to identify opportunities for...

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

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. Immunovant is seeking a Director, Clinical Quality Assurance (CQA) who will lead the management of GCP quality activities in support of one or more clinical programs and trials (from Phase 1 to 4 including non-interventional studies) to drive proactive quality management, and ensure compliance with corporate policies and functional procedures, and applicable regulations for ensuring the protection...

Abbott Nutrition Plant in Casa Grande, AZ is seeking a Compliance Specialist to join our team. The Compliance Specialist is responsible for maintaining and strengthening the Quality management system. The Compliance team manages the documentation system and systems for food safety and internal and external audit programs. The Compliance Specialist develops and keeps all Quality management systems in line with relevant laws & regulations through audit reporting, corrective actions, and validation and verifications. The Compliance Specialist focuses on quality system compliance, including coordination and implementation of new and existing processes. This position works out of our Casa Grande, Arizona...

Abbott Nutrition Plant in Casa Grande, AZ is seeking a Compliance Specialist to join our team. The Compliance Specialist is responsible for maintaining and strengthening the Quality management system. The Compliance team manages the documentation system and systems for food safety and internal and external audit programs. The Compliance Specialist develops and keeps all Quality management systems in line with relevant laws & regulations through audit reporting, corrective actions, and validation and verifications. The Compliance Specialist focuses on quality system compliance, including coordination and implementation of new and existing processes. This position works out of our Casa Grande, Arizona...

We anticipate the application window for this opening will close on - 7 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life We are looking for a passionate Senior...

This Validation Engineer will be responsible for equipment/facility validation projects in a hands on role including writing validation protocols, scheduling and executing testing, gathering and analyzing data, and writing validation summary reports. This person will participate as a supporting member representing validation on project teams. Validation Engineers will lead specific validation projects. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following Design required validation studies and write protocols for the facility and equipment. Coordinate resources required to complete validation studies in a timely manner. Execute validation studies...

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....

Senior Specialist, Quality Assurance Principal Quality Auditor The mission of Quality Assurance is to safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies. This position reports to the Director, Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. As an Associate Director, Global Regulatory Affairs Marketed Products you will Lead/Contribute global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with...

Responsible for quality of assigned New Product Introduction (NPI) combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include infusion pumps, enteral and sub-cutaneous tubing, pump carrying accessories, and other drug administration system accessories. Products may be produced by AbbVie plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships. Develops the appropriate Regulatory, Quality and Product Development strategies for NPI products in concert with Regulatory Affairs, marketing, Product Development and other cross-functional stakeholders....

Purpose The Program Compliance Analyst (PCA) is responsible for monitoring and reconciliation to ensure data is accurate and compliant with 60+ individual country policies; and AbbVie’s OPPFs, procedures, and CFMs for all activity excluding top tier Congress activity. The PCA is also responsible for the successful close-out of activities, ensuring financial, transparency and compliance accuracy of all costs and activity associated with events planned within AbbVie’s Business Service Group or by Third Party Vendors, as required by country specific, federal and state government reporting and regulations. Ensure compliance with all US and country-specific laws and company policies for interacting with...

A Rare Opportunity to Shape the Future of Genomics Join a team of brilliant, passionate innovators determined to transform healthcare. At BillionToOne, we've built a category-defining, publicly traded company on Nasdaq where transparency fuels trust, collaboration drives breakthroughs, and every contribution moves the needle on our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we build products that are 10x better than anything that exists today. Our scientists, engineers, sales executives, and visionaries are united by an unwavering commitment to changing the standard of care in prenatal and cancer diagnostics. This is where...

About the role The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. As Manager Regulatory Lead you will be accountable for recommending and implementing regulatory strategy and coordinating life cycle activities across the portfolio of PDT products. How you will contribute Serves as the regulatory lead for one or more projects and coordinates the Global Regulatory Team (GRT) meetings composed of core regulatory support functions. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of plasma derived therapies, while ensuring...

Executive Director, Global Regulatory Affairs CMC Early Development Are you looking for a patient-focused company that will inspire you and support your career? Join us as Executive Director, Global Regulatory Affairs CMC Early Development (GRA CMC ED). Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Executive Director, GRA CMC Early Development, you will provide strategic and people leadership to deliver innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase 2 development. You will champion fit-for-phase CMC approaches that accelerate development while ensuring product quality, patient...

Position Overview - Basic Functions & Responsibility Essential function(s) includes, but is not limited to Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices including the device constituent part of Combination Products. This position will interact with cross functional teams working with all levels of employees. Activities will include developing, documenting, and maintenance of technical business solutions, reviewing and approving medical device/combination product documentation to support regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical...

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

The Senior Director, Global Quality Systems holds a pivotal leadership position within the Quality organization. This individual is responsible for providing strategic vision and direction to advance the framework, strengthen organizational capabilities, and ensure the sustainability and effectiveness of the Quality Management System. The role is instrumental in promoting leading practices and supporting the organization's growth as well as adapting to industry changes. This leader provides strategic leadership and oversight across all aspects of Global Quality Systems. This includes guaranteeing the integrity and effectiveness of the framework, enhancing capabilities, and ensuring robust execution throughout GxP domains, various products, modalities, and...

Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About AstraZeneca At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Oncology Regulatory Science and Strategy Within Oncology Regulatory Science and Strategy (ORSS) we bring...

You will execute a wide range of regulatory submissions independently, including submissions of high complexity, contribute to global submission content plans, and lead review and planning processes for multiple products or projects. You will represent Regulatory Submission Management (RSM) on relevant product, project, and/or regulatory submissions teams, providing specialist guidance on regulatory submissions requirements and timing. You may also represent RSM on other cross-functional initiatives. You will plan and have oversight for assigned deliverables and may serve as the RSM lead for small to medium regulatory submissions. You will participate in identifying/developing process improvements, new standards, and updating systems in...

Quality Compliance Senior Manager What you will do Serve as a GCP Subject Matter Expert, providing independent and objective quality advice in support of clinical trial activities and in line with current best practice. Provide quality oversight for Amgen programs for all stages of products in clinical development. Plan, conduct and report out on risk-based GCP audits (investigator site audits, affiliate audits, service provider audits, and study level audits) or support outsourced audits. Manage/support regulatory inspections and provide guidance and feedback on responses to health authorities, including root cause and CAPA plans. Provide quality oversight for the Risk Assessment...

This position sits within the Regulatory Affairs Data and Product Release group in the Medtronic Clinical & Regulatory Solutions (MCRS) organization and leads the global Product Release team. The role is responsible for providing strategic direction and people leadership, coaching and developing managers and teams to deliver timely, accurate, and compliant product releases in support of global market access. A role within MCRS offers a unique opportunity to be part of a global, high-impact team, collaborating across functions, gaining visibility into enterprise-wide structures, and contributing to initiatives that drive meaningful impact across Medtronic. At Medtronic you can begin a life-long...

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

Duties/Responsibilities Lead the Campus IT Compliance and CSV team Promote a safe and compliant environment and mindset. Select, develop, coach, and manage the Devens Campus IT Compliance and CSV team. Set goals, objectives, and contributions of the Campus IT Compliance and CSV team. Drive continuous improvement of team productivity and KPIs. Ensure the team delivers critical projects on time. Act as a liaison between site stakeholders and enterprise/business application teams to ensure business continuity is maintained. Manage service providers and ensure alignment with contractual SLAs. Engage and support PBRG teams in support of the BMS culture. Act as the Computer...

The Manager Quality Systems - Change Control and Quality Risk Management (QRM) is responsible for supporting ownership and oversight of assigned quality systems per established local and global standards. This position supports the overall compliance and performance of the Change Control and QRM processes as they apply to the site level, including periodic assessments of process performance and continuous improvement opportunities. Duties/Responsibilities Support oversight of the Devens Cell Therapy site Change Control system, including facilitation of site Change Control Review Board. Drive Change Control governance maturity plans to improve site performance through data-based analysis and integration of management review through...

Key Responsibilities Own site‑level quality oversight for Manufacturing and Laboratory IT systems, including support for deviations, investigations, and CAPAs, ensuring sustained compliance and inspection readiness. Accountable for IT Change Management governance, providing risk‑based oversight and acting as the primary site authority for IT change control. Act as a Validation Lead for Manufacturing IT and OT systems, accountable for approval and lifecycle compliance of CSV and SDLC deliverables. Maintain ongoing compliance accountability for IT systems, procedures, and training supporting CAR‑T manufacturing and laboratory operations. Lead the Site IT System Periodic Monitoring program, ensuring effective execution, documentation, and remediation of compliance risks....

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...

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. We are recruiting for a Sr. Manager, Tech Quality Assurance to join our team on-site in Alameda, CA. In this role, you will be responsible for providing assurance that product...

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation and general support of global regulatory activities. This role requires strong attention to detail, technical competence, and effective communication skills to collaborate across multiple functional areas. Proven successful track record of authoring/submission/approval implantable medical devices is preferred. What You’ll Work On Authoring and submitting US PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports), 510(k)s and EU change notifications. Review/approval of engineering study protocols/reports and validation study...

Regulatory Affairs Project Manager Our nutrition business develops science-based nutritional 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 get the nutrients they need to live their healthiest lives. 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...

The Program Operations Compliance Manager will play a critical role on the HCO team at Genentech. This role is responsible for operational elements and compliance guidance and reviews for external funding requests (e.g., grants, exhibits, sponsorships, corporate memberships), Advisory Boards, fair market value (FMV), and other areas of business need as assigned, including ensuring adherence to and oversight of applicable Genentech processes and guidelines. The role requires an individual with strong subject matter expertise on state and federal laws on interactions with healthcare professionals, a strong operational mindset to redesign workflows, eliminate bottlenecks, and actively implement cutting-edge technologies—including AI and...

Manager Trainee — Quality (Travel and Relocation Required) Here is your opportunity to build a career in healthcare while fast-tracking your path to growth. As a Manager Trainee – Quality with BioLife Plasma Services, a subsidiary of global leader Takeda Pharmaceutical Company , you will learn and work in a structured management training program. You’ll build leadership skills that set you up for future growth, while receiving step-by-step training on how to rigorously monitor quality at our plasma centers. Upon completion of the program, you’ll advance into the role of Quality Manager Representative at one of our 175+ and counting...

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 employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans....

We are searching for the best talent for Senior Specialist, Supplier Quality to join our Innovative Medicine Quality Organization located in Raritan, NJ; Horsham, PA; Spring House, PA; Wilson, NC; or Gurabo, Puerto Rico. 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 Within the JJIM Supplier Quality...

Lead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global regulatory initiatives. Lead global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of product submissions. Develop global CMC regulatory strategies to enable life-cycle product/process development strategy while maintaining global licensure and right to operate of Gilead’s operations. Lead the execution of these global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development. Lead the integration and implementation of CMC Team Leaders...

The Senior Director, Device Quality provides global strategic leadership and accountability for Quality across medical devices, drug device combination products, companion diagnostics (CDx), and precision medicine–enabling platforms, including CLIA certified laboratory operations supporting clinical trials and commercial diagnostics. This role ensures patient safety, robust regulatory compliance, and sustained inspection readiness across the full lifecycle—from early development through commercialization and post market surveillance. The Senior Director partners closely with Precision Medicine, R&D, Clinical Development, Regulatory Affairs, Global Manufacturing, External Manufacturing, and Commercial teams to embed quality by design into innovative, personalized medicine solutions. This role is a key strategic position within...

This position works out of our Alameda, CA location within the ADC Division. Our mission is to empower people with diabetes to manage their health through innovative products that deliver precise data for better decision-making. We're transforming glucose monitoring with our cutting-edge sensing technology. As a Senior Specialist Import & Export, you will provide subject matter expertise to ensure site compliance with all relevant customs regulations and trade laws and regulations, including 19CFR, FDA, and other US regulatory agency requirements. This is an onsite opportunity in Alameda, CA. What You’ll Work On Responsible for compliance with applicable Corporate and Divisional...

Role is heavily focused to support the key site digital/software/automation transformation and related validation activities. The first two years will focus on validation of digital tools (MES systems, software, etc) and may require continued administrative support of this system. Responsible to perform adequate and comprehensive qualification and validation of equipment, processes, products, and facilities at the Redwood City site to support the site goals and targets. Responsible for assuring the design, installation, implementation, data integrity and validation of computer systems meet all applicable industry standards and regulatory requirements to support the site goals and targets. System or business owner and...

We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with 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...

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....

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...

We aspire to be the premier research-intensive biopharmaceutical company. At the forefront of research, we deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. The Director, Microbiological Quality and Sterility Assurance (MQSA) provides global leadership for microbiology-related topics across sterile, non-sterile, biologic, and vaccine manufacturing, as well as associated laboratories. This role sets and maintains quality standards and policies to ensure cGMP compliance, partners with sites across the network as a subject matter expert, and leads cross-site initiatives to drive consistency and continuous improvement. Join our team and use the power of leading-edge...

Regulatory Affair Director - Global Regulatory Leader (Rare Disease) What you will do The Global Regulatory Leader (GRL) is a product facing role that leads the Global Regulatory Team in the Regulatory Affairs organization. In this vital role you will lead one or more Global Regulatory Teams within Amgen’s Global Regulatory Affairs department and develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions. Additionally, you will provide regulatory expertise and guidance to product teams (eg, Product Team (PT),...

Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance What you will do In this vital role you will provide strategic direction for product and disease communications and activities by interpreting current FDA regulatory environment to ensure truthful and non-misleading communication to health care community, patients, and the public. This position is primarily responsible to formulate and communicate the regulatory promotional position for approved and/or pipeline products. Key Responsibilities Promotional review committee experience in evaluating proposed pieces and supporting evidence Evaluate promotional enforcement activities and assess the changing regulatory environment to determine impact on Amgen Update the Promotions group...

The Sr. Compliance Engineer will be involved in projects that require obtaining agency approvals for both new and existing products. This role requires experience in securing certifications from agencies such as the FCC, CE, EMC/RED, IC, and safety organizations. Familiarity with relevant standards and directives from UL, CSA, FCC, IEC, and EN is essential. Additionally, experience with environmental regulations such as RoHS, WEEE, REACH, and Proposition 65 is a valuable asset. The Compliance Engineer will create and execute a compliance test plan addressing EMC, EMI, safety, environmental, and other product compliance requirements. Key Responsibilities Read, interpret, and communicate changes in...

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

Calico is seeking a Regulatory Director that will be responsible for, in collaboration with development partners as applicable, developing and implementing innovative regulatory strategies to support development programs, in compliance with health authority guidelines and regulations. The successful candidate should be able to collaborate effectively with cross-functional representatives, collaboration partners, external vendors, and stakeholders, while maintaining a positive team environment. Position Responsibilities Accountable to develop and execute the world-wide regulatory strategy for assigned programs (from IND-enabling to clinical proof-of-concept and beyond), which may include programs that are first-in-class, where no or limited FDA guidance exists, that have an external business...

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. The Senior Manager, North America Regulatory Liaison will serve...

Located in Foster City, CA - this is a hybrid (3 days onsite) role. As a Sr Director, Regulatory Affairs at Gilead, you will... Responsible for leading and providing strategic input to all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Responsible for leading a team of Regulatory professionals supporting both early phase and marketed products. Responsible for ensuring responsibilities of Applicant and/or Marketing Authorization Holder defined in legislation or regulatory guidance's are met for assigned product(s) and territories. Responsible for submitting or ensuring submission of all...

This position works out of our Abbott Park, IL facility or an Abbott facility within the US. This is not a remote role. What You’ll Work On The function of the Quality Program, Manager is to provide leadership, oversight, and project management covering Abbott's Quality System. This includes division / business support and quality expertise and consulting activities. MAIN RESPONSIBILITIES 1. Lead global committees and teams 2. Provide direct business support 3. Participation in industry groups 4. Improve the effectiveness of the Abbott Quality System, including monitoring, trending and analysis of Abbott compliance performance 5. Act as a change agent...

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...

As part of product development teams, executes product registration submissions, progress reports, supplements, and amendments. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liaison throughout product lifecycle. Participates in some of the following product plan development and implementation, regulatory strategy, risk management. Ensures timely approval of new medical devices and continued approval of on-market products and product changes. Serves as regulatory representative to marketing, research teams and regulatory agencies. Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Core Responsibilities Career development with an international company where you...

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

Regulatory Affairs Manager Introduction to role Are you ready to lead regulatory submissions that accelerate access to life-changing medicines? Do you thrive in a dynamic setting where your judgment shapes approval pathways and your work directly impacts patients in need? As a Regulatory Affairs Manager, you will own end-to-end planning, coordination and delivery of regulatory submissions across regions and modalities, translating scientific strategy into high-quality applications that secure timely approvals. You will identify risks and opportunities, advise cross-functional teams on procedural and documentation requirements, and guide products through development, authorization and lifecycle management. This role places you at the heart...

Experience in the medical device industry as a supplier quality engineer or manufacturing quality engineer preferred. Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost...

Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools for complex spine and cranial procedures. Platforms such as AiBLE™ connect these technologies to enhance surgical precision, streamline workflows, and support improved patient outcomes across...

That’s what makes us Roche! The Opportunity The PDQ Principal Quality Lead supports the Roche/Genentech Organization through the development and delivery of Quality strategies, audits and conclusions for entities (e.g. molecules in development, post approval products, affiliates, processes) based on a risk-based approach. Quality strategies are based on the Critical to Quality framework which encompass Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Personalised Healthcare (PHC) and Computer Systems (CS) requirements. The Quality Lead will generate Quality strategies, evidence and actionable data through the conduct of audits and other quality activities to assess the Quality status and be able to...

This role has responsibility and accountability for Ensuring that the facilities, equipment, systems, and processes used in the manufacture and testing of Pharmaceuticals have been appropriately validated and maintained in a validated state. Organizing and directing all validation activities including capital projects. Working with operations, requiring technical service support for process, product, facilities, and cleaning validation, change control, and continued verification which are essential for GMP and regulatory compliance and continuous improvement objectives. Ensuring robust and compliant validation and change control efforts. Provide leadership and direction to enable the site to meet its business goals by ensuring that laboratory business...

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 product. We need the...

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

Regulatory Affairs Senior Associate What you will do In this vital role you will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. Responsibilities Assist US Regulatory Lead (USRL) to support US regulatory activities (e.g. development and submission of Investigational New Drug [IND] applications, Biologic License Applications [BLAs] and New Drug Applications [NDAs]; advisory committee meeting preparations) Provide and maintain IND/BLA/NDA documentation support (e.g. annual reports, amendments) in collaboration with USRL Create and maintain product regulatory history documents in the regulatory...

Bristol Myers Squibb is seeking an Associate Director, Regulatory Excellence & Hematology/Oncology Operations to lead operational and business management activities within the Oncology/Hematology organization. This role serves as a strategic partner to leadership, driving execution of portfolio priorities, operational planning, compliance, and regulatory excellence initiatives across a team of approximately 45 professionals. The successful candidate will be recognized internally as a subject matter expert in regulatory operations and business management, exercising considerable latitude in shaping deliverables, leading initiatives of strategic importance, and developing solutions to highly complex, sometimes novel problems with broad impact across the department. The role requires anticipating...

Associate Director, Global Regulatory Strategy, Hematology/Oncology Position Responsibilities as a Global and US Regulatory Lead In conjunction with the Team leader; develop global regulatory strategy in development and through life cycle management taking into account all relevant guidance, commercial needs, and company objectives. Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions. Work with cross-functional groups to define and manage contributions to submissions. Writing regulatory documents (e.g. new INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents...

KNOWLEDGE AND SKILLS REQUIRED BS in Science, Engineering, or technical related field. Five 5 years of experience in Engineering Department related matters in the biopharmaceutical industry. Knowledge of EOHSS, cGMP’s, local/Federal regulatory requirements, and documentation procedures pertaining to a biopharmaceutical manufacturing plant. Timely and effective decision making, and timely conflicts resolution skills. Computer literate with the ability to understand and use basic computer software packages like Excel, Word, Power Point, Internet, etc. Ability to read and interpret layout drawings, mechanical, pneumatic and electrical blueprints, is preferred Fluently in English/Spanish (Oral and Written) Strong interpersonal relationship skills with subordinates, peers,...