Quality & Regulatory Jobs in Pharma & Biotech

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor (QASF) organization has responsibility for quality oversight and responsibility for advising and assuring quality operations at...

Sr. Supplier Quality Engineer 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. Our location in Temecula, CA , currently has an opportunity for a Senior Quality Engineer . This role will serve as liaison between internal Abbott third party manufacturers and Abbott Vascular. Ensures effective implementation of quality and compliance requirements between multiple quality systems and sites. THIS IS AN ON-SITE DAILY ROLE. WHAT YOU'LL DO Position Responsibilities Work...

JOB SUMMARY The Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides comprehensive regulatory program management support that ensures alignment with and execution of Pfizer Oncology’s regulatory strategies and submission deliverables. This position is accountable for coordination and prioritization of regulatory activities, facilitation of decision-making processes, and oversight of information flow to ensure adherence to regulatory timelines and commitments. The Manager, RPMSS plays a critical role in partnering with regulatory strategists to advance regulatory and submission activities for assigned programs within the oncology portfolio. JOB RESPONSIBILITIES The Manager, RPMSS will provide comprehensive support to Pfizer Oncology’s Global Regulatory Strategy Teams...

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

Purpose The QA Validation Analyst/Engineer is responsible for planning and overall approval of validation tasks. Responsibilities may also include executing validation activities. Under the direction of the Validation Section Manager, this individual will participate in the implementation of the Validation quality program at the plant under minimal supervision. Level of responsibility and performance is commensurate with grade level. The Validation Engineer responsibilities may include the review of commissioning and validation documentation completed by others, leading, authoring or reviewing investigations and implementation of preventive and corrective action, review and authoring of plant standard operating procedures, review and approval of critical planned...

The Associate Business Systems Consultant supports the integration of Business Technology Solutions (BTS), Software Quality Assurance (SQA), Compliance, and Technology Enablement teams in delivering solutions aligned to the Technology Solution Lifecycle (TSL). The role assists in interpreting and translating pharmaceutical regulatory requirements (GxP, CSV, Part 11, Annex 11) and ensuring they are embedded into technology practices and CI/CD pipelines. Supports identification of strategic business opportunities, shaping compliant technology solutions, leading process modernization, and ensuring alignment of digital quality engineering with business and regulatory expectations across multiple business areas. Responsibilities Support liaison activities between SQA, Compliance, and BTS technology enablement teams;...

About GenerateBiomedicines GenerateBiomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform...

The Manager/Senior Manager, Regulatory — Advertising, Labeling, and Promotion (ALP) is responsible for leading U.S. promotional regulatory strategy and supporting ex-U.S. needs across our gene editing portfolio. This role reports to the Director of Regulatory Labeling and serves as a key member of the Promotional Review Committee (PRC/MLR). The position ensures compliant, compelling, and scientifically accurate communications consistent with core labeling and regulatory requirements. Responsibilities Serve as Regulatory lead for PRC/MLR review of promotional, disease awareness, scientific exchange, HCP, and patient-directed materials for certain products, under the supervision of the Director of Regulatory Labelling. Manage the lifecycle of core 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 Supplier Quality Intern to be in Santa Clara, CA. The Intern term is from June to August, 2026. Full time requirement (40 hours per week). Purpose The Quality Engineering Intern will participate and learn about the basics of Supplier Quality processes. Under the guidance of the Hiring Manager and Mentoring Engineer(s), the Intern will...

POSITION SUMMARY The Manufacturing Quality Engineering Co-op will assist in sustaining and improving the quality processes across the manufacturing workflow to ensure quality product is produced and quality procedures are upheld. KEY RESPONSIBILITIES Participate in the investigation of failures and formulation/implementation of action plans for nonconformances, internal corrective actions, and audit findings. Work in cross-functional teams to identify and address non-conformances throughout assembly to final shipment of product. Work with engineering teams to ensure quality procedures are followed in all manufacturing and distributing areas. Use Lean and Six Sigma tools to analyze non-conformance data and identify...

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 Regulatory Intern to be in Santa Clara, CA . The Intern term is from June to August, 2026. Full time requirement (40 hours per week). Purpose The Regulatory Affairs Intern will participate and learn about the basics of Regulatory processes and procedures in order to assist in Regulatory research, project publishing, organization and benchmarking,...

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 Director, Global Regulatory Leader. This position is a hybrid role and can be located in Spring House, PA; Titusville, NJ; or Raritan, NJ. Remote work options may be considered...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Reducer Quality Intern to be in New Brighton, MN. The Intern term is from June to August, 2026. Full time requirement (40 hours per week). Purpose The Quality Engineering Intern will gain hands-on experience in the fundamentals of Quality processes and procedures. Under the guidance of the hiring manager and designated mentors, the intern...

WHY JOIN US? Transform billions of patients’ lives through technology, data, and innovative ways of working. You’re disruptive, decisive, and transformative. Someone excited to use technology to improve patients’ health. We’re building a new Health-tech business – Evinova, a fully-owned subsidiary of AstraZeneca Group. Evinova delivers market-leading digital health solutions that are science-based, evidence-led, and human experience-driven. Thoughtful risks and quick decisions come together to accelerate innovation across the life sciences sector. Be part of a diverse team that pushes the boundaries of science by digitally empowering a deeper understanding of the patients we’re helping. Launch pioneering digital solutions that...

Reporting to the AVP of New Modalities Manufacturing Division Quality, this leader is responsible for providing Antibody Drug Conjugate (ADC) expertise and supporting a quality oversight model necessary to facilitate agility and speed-to-market while ensuring sustained, compliant supply of specialty New Modalities pipeline products to global markets, to serve our patients. This leader will leverage ADC experience to support the implementation of a fit-for-purpose quality management system and ensure strategic quality oversight of new modalities products manufactured in our company's network and at external partner sites. The leader will interact with our company's cross-divisional/functional teams from development through commercialization to...

At our company's Wilmington Biotech site, we are committed to ‘Using the power of leading-edge science to save and improve lives around the world’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. The Wilmington Biotech site will play a pivotal role in the manufacturing of our company's biologics-based medicines, including in the area of immuno-oncology. This site will establish our company's internal capability to manufacture high potent compounds with full manufacturing and testing operations....

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose The Senior Clinical Quality Lead – Oncology serves as the...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Quality Assurance Floor Support Specialist (Nights) Organization Overview At Lilly,...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly is on the cusp of a transformative expansion, investing over...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we unite caring with discovery to make...

As a Senior Regulatory Affairs Program Manager, you will be the strategic linchpin that drives operational excellence across the different arms of the RA function within the Acute Care & Monitoring (ACM) operating unit. Your day will be a dynamic mix of strategic planning and tactical execution. A significant portion of your day will involve facilitating program-level meetings with leadership, where you will use your expertise to guide strategic discussions, manage through risks, and drive critical decisions to ensure the functional commitments are met. You will also dedicate time to analyzing and interpreting complex performance data, balancing resource demand across...

The Executive Director, Regulatory Operations is responsible for leading the teams of publishing, submission management, regulatory information management, compliance and the regulatory management office. This role will be accountable for creating a high quality organization that utilizes the best in technology, process and project management to deliver global submissions in a highly effective and efficient way. This role will drive the strategic framework for how GRA operates as a group including centralized oversight of functional strategic objectives. Key Duties and Responsibilities Leads the Submissions Management & Publishing groups, and the delivery of quality global dossiers to HAs utilizing effective planning...

Responsible for t he p rin c ip l e s a nd a ppl i ca t i on of qu a l i t y a n d GDP re g ulato r y c omp l ia n ce supporting the global processes for distribution of Vertex materials, intermediates, and finished medicinal products (commercial) across its global distribution network. Stakeholders include GMP QA, Market Quality, Global Logistics, Vendor Management and AIM. This position reports directly to Associate Director/Director, Distribution Quality Key Responsibilities The responsibilities of this position will include, but are not limited to, the following Distribution...

The Associate Director, GMP Operational Quality is an advanced technical resource in the principles and application of quality assurance and compliance. This role is responsible for primary QA oversight of commercial drug substance manufacturing performed at Vertex’s external vendors as well as secondary quality support of commercial drug product manufacturing vendors. This position ensures robust sterile manufacturing controls, commercial supply continuity, support for global jurisdictional expansion, and high‑level combination product quality alignment. The incumbent will mentor team members to provide individual development in addition to efficient and valuable service to project teams. Key Duties and Responsibilities Collaborate with internal and...

The Quality Manager is a technical resource in the principles and application of quality assurance and compliance. This position performs and leads activities “on the floor” in support of batch records review and disposition while ensuring compliance with cGMPs policies and procedures. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects. Key Duties and Responsibilities Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions Lead root-cause analysis and product impact assessment for investigations as a result of deviations,...

General/ The Director, Quality Assurance GMP Operations will oversee the GMP QA operations including batch disposition process across CDMOs in the US and Internationally. Responsibilities include day-to day operational quality oversight for internal batch record review operations and QA manufacturing operations from clinical to commercial stage of product globally. The role will closely partner with operational stakeholders to lead/support the development and execution of quality & technical risk mitigation, execution of operational activities participation of governance committees associated with improvements to the disposition process. A key expectation is the ability to closely collaborate and build relationships with internal and external...

General/ The Director, Quality Oversight Lead within Global Clinical Quality (GCQ) is responsible for strategic and operational oversight of key activities such as inspection readiness, the GCQ operational framework, continuous improvement initiatives, and expert guidance on computer systems assurance in a clinical trial setting. Additionally, the Director will be responsible for providing quality oversight to Clinical Development and Biometrics functional areas. We seek an individual with strong leadership skills, expert drug development and GCP knowledge, and advanced understanding of the application of inspection readiness principles in a clinical trial setting. This position reports directly to the Senior Director of Global...

The Director, GDP Operational Quality is r esponsible to partner with Trade Operations to support the distribution of Vertex’s commercial product portfolio. The role is responsible for oversight of team activities, development of personnel and ensuring timely completion and quality of deliverables/goals within their remit. The role supports GDP quality operations for all distribution activities within the US; key stakeholders include Trade Operations, Vendor Quality Management & Quality Compliance. Key Duties and Responsibilities The responsibilities of this position may include, but are not limited to, the following Primary quality partner for Vertex US Trade Operations organization, providing quality input and...

The Executive Medical Director, Patient Safety/Head Medical Safety and Risk Management will oversee all safety and benefit-risk related activities of the GPS Physician (Disease-area Safety Heads, DST Chairs) and the Aggregate Report Risk Management (ARRM) Groups within the Vertex Global Patient Safety (GPS) Department. As a member of the GPS Senior Leadership Team, the role will contribute to ensuring consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Overseeing the GPS DASH/DST teams across therapeutic areas, the role will ensure consistent conduct and timely execution of Benefit-Risk activities by GPS DASH/DST...

General/ The Senior Manager, Quality Assurance Technical Services will execute and provide quality support and oversight for Quality Engineering and Validation programs at Vertex Cell and Genetic Therapies sites. This role is responsible for executing QA activities for validation of equipment and systems, facility and equipment change controls, CAPAs, validation-related deviations, and all validation lifecycle documentation. Furthermore the role will support the calibration and Maintenance program QA oversight activities. Acting as a trusted advisor, the Senior Manager will collaborate with site operation business partners to ensure compliance, address quality issues, and drive continuous improvement. This is a 5 days on...

The Associate Director, GMP Operational Quality will provide leadership and quality oversight for contract testing laboratories (CTLs) supporting Vertex’s biologics and combination product portfolio across development, PPQ, launch, and commercial lifecycle management. This role ensures that analytical testing, method execution, and data generated by external laboratories meet Vertex, global regulatory, and data integrity standards. Key Duties and Responsibilities Serve as the primary QA lead for CTLs supporting release, stability, characterization, and device-related testing for Vertex’s biologics and combination products. Provide quality oversight for analytical method qualification/validation, method transfer, and lifecycle management activities executed by CTLs. Review and approve analytical protocols,...

General/ Senior Manager, GMP Quality Operations is a technical resource in the principles and application of quality assurance and compliance. The Sr. Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects. The role is responsible for maintaining documents reconciliation, labeling control, master batch records and issuance of batch records for production. The quality senior manager is responsible for implementing strict issuance tracking, controlling version updates, and ensuring data integrity (ALCOA+) to prevent unauthorized changes and ensure product safety The role will closely partner with operational stakeholders...

The Compliance Associate Director assists in implementing and further enhancing the anti-corruption/anti-bribery Compliance program. Reporting to the Executive Director Head of Global Compliance Program Strategy, Assurance and Management, the Compliance Associate Director will be responsible for executing compliance-related investigations and supporting the company’s global healthcare fraud and abuse assurance program and activities, including auditing and monitoring, both transactional and live. The Compliance Associate Director will serve as the initial point of contact for business colleagues for these activities, will support department initiatives globally and must have knowledge of the biotechnology/pharmaceutical industry, anti-bribery/anti-corruption laws, and experience executing compliance-related investigations as well...

The Associate Director is recognized as an expert in the principles and application of quality and regulatory compliance. The individual adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with regulatory requirements. This role is responsible for oversight and coordination of GMP activities in support of Commercial Release and serves as primary QA contact on cross-functional teams. The Associate Director manages and develops personnel and support department and functional activities. KEY DUTIES AND RESPONSIBILITIES The responsibilities of this role may include, but are not limited to, the following Responsible for oversight of analytical activities...

At Vertex, quality is at the heart of everything we do, especially as we pioneer transformative advancements in Cell and Gene Therapy (CGT). The CGT Quality Lead is a critical member of our Data, Technology, and Engineering (DTE) team, ensuring that the Vertex Connects Portal for CGT systems and integrated applications meet the highest quality standards and regulatory compliance. This role is pivotal in safeguarding the integrity of our CGT applications by managing quality deviation life cycle processes, collaborating with Quality partners, and ensuring timely resolution of quality events. The CGT Quality Lead will play a key role in driving...

Vertex

The Associate Director, GMP Operational Quality is responsible for quality oversight of QC data review for both non-routine and routine cGMP process testing and in support of stability testing of Cell & Genetic Therapy products. The role will also oversee team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates...

Role Summary Supervise medical reviews for ICSRs during both clinical development and post-marketing, managing workflows and oversight to ensure evaluations are timely, accurate, and compliant. Serve as the main contact between operations and global patient safety medical teams. This position will contribute to setting standards, enhancing quality and inspection preparedness, executing vendor management, and working with both internal and external stakeholders to share medical expertise with operations teams and communicate operational regulatory requirements to the medical and PV Science groups. Key Responsibilities Lead the operational strategy and standards for ICSR medical review across all case types. Conduct thorough clinical evaluations,...

The Quality Manager is a technical resource in the principles and application of quality assurance and compliance. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects. The role will also have responsibilities associated with QC data review for both non-routine and routine cGMP process testing and in support of stability testing of Cell & Genetic Therapy products. This role requires collaborative interaction with cross-functional partners such as analytical and process development, clinical and commercial QC, and manufacturing operations to ensure the on-time closure of...

The Associate Director, Vendor Quality Management is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GxP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and analytics, including but not limited to vendor key performance indicators, vendor quality metrics, and a vendor risk scorecard, to QA and to key business partners at the enterprise and program levels. The role also drives continuous improvement in Vertex vendor quality processes and governance to assure Vertex remains adherent to regulatory expectations and supports QA operational quality oversight and management...

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. Foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. This critical role Influences the development of external regulations, guidance, policy, and other initiatives that are external and relevant to Sanofi. Obtains Quality Intelligence through regulatory surveillance, benchmarking and participating in Trade and Industry Associations. Serves to clarify the existing regulatory framework to inform our internal compliance...

Sr Associate Quality Control What you will do In this vital role you will complete and review analytical testing in our cGMP laboratory. The role will be on-site based out of Amgen Rhode Island and will work under the mentorship of the front-line manager. The Bioanalytics team provides analytical expertise in testing the following in-process, release and stability samples. The laboratory employs a variety of test methodologies that use sophisticated equipment including HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing. Responsibilities include Follow safety guidelines, cGMPs...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Associate Vice President – Head of Digital Strategy and Innovation...

The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and...

The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and...

The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and...

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. The Quality Control Central Services Technician is responsible for the preparation of materials for analytical testing in the QC lab,...

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We are seeking an experienced and highly motivated Senior Manager, QA to support site manufacturing operations as they pertain to the development and commercialization of new combination products. This role offers an exciting opportunity that will be key to Gilead's success as we...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. The Director, Global Compliance Systems and AI Enablement will lead the strategy, development, and execution of advanced technology solutions, particularly AI-driven tools,...

JOB SUMMARY The Senior Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides comprehensive program management, ensuring alignment and execution of Pfizer Oncology’s regulatory strategic and operational deliverables. The Senior Manager, RPMSS is responsible for ensuring all cross-functional regulatory deliverables are achieved on or ahead of schedule and with quality that meets or exceeds business needs. The Senior Manager, RPMSS is viewed as a key member of the GRST (Global Regulatory Strategy Team). The Senior Manager, RPMSS’ responsibilities encompass regulatory strategic and scenario planning, execution of regulatory and submission deliverables, team effectiveness, resource management, risk management, and information and communication...

Job Summary The Asset Quality Lead (AQL) is responsible for driving GCP Quality by maintaining ‘quality’ line-of sight for assigned clinical trial programs/protocols. With this focus, the AQL role brings deep knowledge of GCP quality and risk management principles to asset and study teams. In partnership with the cross functional study team and functional lines in Clinical Development & Operations, the AQL will ensure program and study level quality oversight, drive quality risk management and inspection readiness activities and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS. The AQL is...

As a Senior Quality Systems - CAPA Specialist, you will have responsibility for coordinating the Medtronic Energy and Component Center (MECC) Quality CAPA Portfolio. Coordination includes partnering with those team members to define, investigate, execute, and resolve product and quality systems issues to ensure they don’t recur. By supporting the Quality Function, you will provide critical compliance guidance and direction for CAPA impacting battery and component nonconformances, complaints, regulatory reporting, PHO, and FCA. Responsibilities will include additional Quality Management System project work as needed. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in...

The Quality Systems Program Manager will drive the governance and execution of the Quality Management System (QMS) Simplification Program within Enterprise Core Quality Services (CQS). This role is responsible for leading program activities, monitoring performance metrics, facilitating meetings, and managing key projects to support continuous improvement and operational excellence. Key Responsibilities Promote global standardization and best practice sharing to support the company’s mission worldwide. Oversee governance of the QMS Simplification Program, ensuring alignment with organizational goals. Lead strategic planning with the Core Team and Process Leaders ensuring effective communication and decision-making. Represent CQS in OU/Enterprise Quality Leaders team meetings; collaborate...

Kickstart Your Career at Vertex! Are you ready to make a real impact? At Vertex, our mission is to tackle serious diseases and to change lives, for the better, for the future. Our aim is to give you the skills, insights, and career guidance to be an important part of that future; to turn your potential into progression. As a Vertex intern or co-op, you’ll work on meaningful projects, collaborate with talented teams, and learn from industry leaders. We’re passionate about innovation, inclusion, and supporting your growth—inside and outside the lab. Why Vertex? Real Projects You’ll work on assignments that...

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Associate Quality Control - Nights What you will do In this vital role you will play a key...

Senior Associate Quality Control Lead - Nights What you will do In this vital role you will play a key role in the Quality Control team as the lead for night shift support. Reporting directly to the Director of Quality Control, the Senior Associate, Quality Control I (Night Shift Lead) is an experienced QC professional who provides independent technical execution and shift-level leadership within a GMP-regulated laboratory environment. This role is accountable for leading night shift QC operations, ensuring accurate sample management, timely analytical testing, and sustained compliance with GMP, data integrity, and safety requirements. Provide operational leadership for...

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Associate Quality Control - Nights What you will do In this vital role you will...

The Senior Validation Engineer for Facilities Utilities & Equipment (FUE) Qualification is responsible for leading, planning, executing, and maintaining qualification/validation activities at AbbVie’s manufacturing site. This role ensures that all systems are installed, commissioned, qualified, and maintained in compliance with regulatory requirements, internal quality standards, and industry best practices. The successful candidate will serve as the subject matter expert (SME) for equipment, facility and utility validation, lead cross-functional projects, and drive continuous improvement in validation strategies and lifecycle management. This position is fully onsite Monday-Friday. Open to considering non-local candidates; relocation required. Responsibilities Lead and execute qualification activities for facility...

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

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Sanofi has been one of the leaders in the vaccine industry for more than 100 years and a globally recognized partner in the prevention of infectious diseases. We believe in a world in which no one suffers or dies from a vaccine-preventable disease. The Swiftwater site is the reference site...

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. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned...

Use Your Power for Purpose This role provides strategic leadership & operational Quality oversight for development, deployment and enablement of GxP AI capabilities across QSEO and PGS Operations. The AI Compliance Lead is responsible for enabling the deployment of AI initiatives while ensuring all forms of risk are mitigated. This role partners closely with QSEO GPOs and BSOs, as well as with Digital, Legal and other relevant stakeholders to ensure AI capabilities built in Pfizer or through 3rd parties adhere to applicable external regulatory requirements as well as Pfizer specific policy and controls. The AI Compliance Lead plays a key...

Johnson & Johnson is currently recruiting for a Staff Quality Engineer! This position will be located in Cincinnati, Ohio. This position will support New Product Development or Lifecycle Engineering within the Energy Quality organization, based in Cincinnati, OH This position will support the Energy franchise that may include Harmonic, Advanced Bipolar, Capital and Megadyne. Defines, leads and implements state-of-the-art quality engineering focus and improvements in design and development of products, and in transfer and steady state phases of manufacturing operations. Influences the company's business, tactical directions, and financial results through a sharing of technical expertise. Performs complex design analysis...

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

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...

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...

Ready to redefine what's possible in molecular diagnostics? Join a team of brilliant, passionate innovators who wake up every day determined to transform healthcare. At BillionToOne, we've built something extraordinary—a culture where transparency fuels trust, collaboration drives breakthroughs, and every voice matters in our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we strive to build products that are 10x better than anything that exists today.Our people are our greatest asset talented scientists, engineers, sales professionals, and visionaries united by an unwavering commitment to changing the standard of care in prenatal and cancer...

The Senior Director, GCP & GPV will lead clinical quality and pharmacovigilance strategy across development-stage programs. This role ensures global Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPV) compliance, provides guidance on clinical trial operations and safety reporting, and fosters a culture of quality, compliance, and patient safety. The Senior Director drives proactive risk identification and mitigation across the clinical development and pharmacovigilance lifecycle, ensuring inspection readiness and effective regulatory engagement. This leader will partner cross-functionally to embed quality and safety considerations in clinical planning and will oversee a small, high-performing team of quality and pharmacovigilance professionals. Here's how...

POSITION OVERVIEW - Basic Functions & Responsibility Essential functions include, but are not limited to Under the general direction of the Director, Wilson Q.O., the Manager is responsible for administration of NASU and Wilson laboratories. The Manager or "Coach" ensures that all compliance regulations, cGMPs, and internal guidelines are adhered to and/or enhanced. The Manager manages activities to implement productivity enhancements to streamline activities. TI1e Manager executes activities to meet or exceed customer expectations through a staff of professionals at the B.S., BA, M.S., and Ph.D. levels. PRIMARY ACTIVITIES - Primary activities include, but are not limited to 1) Drives...

The Senior Radio Regulatory Affairs Specialist is responsible for leading global RF/Wireless regulatory compliance activities for RF‑enabled devices within the Acute Care and Monitoring (ACM) Operating Unit throughout the product lifecycle. The Senior Radio Regulatory Affairs Specialist is dedicated to the Acute Care and Monitoring (ACM) Operating Unit. In this role, the specialist supports New Product Development (NPD) programs and product lifecycle maintenance activities across the RF‑enabled device portfolio. The specialist collaborates closely with Regulatory Affairs colleagues, cross‑functional partners at all levels, external test laboratories and certification bodies, and International Regulatory Affairs teams to ensure ongoing compliance with global RF,...

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. Defines appropriate measures to ensure product quality. Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. Reviews software systems design, change specifications, and plans against contractual and/or process requirements. Reviews include applicable...

Responsibilities may include the following and other duties may be assigned. Develops, implements, administers and certifies compliance policies, procedures, and practices. Ensures alignment with legal and ethical standards of the organization. Provides compliance advice, investigates complaints and verifies deficiencies are corrected. Develops employee communication and training programs that focus on the elements of a companywide compliance program. Enforces anti-bribery and anti-competition laws. Analyzes metrics and audits functional compliance program. Maintains current knowledge of laws for financial, advertising and marketing reporting, regulations, and industry guidance that impact the company's compliance program. SPECIALIST CAREER STREAM Typically an individual contributor with responsibility in...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Cardiac Ablation Solutions (CAS) is one of the Operating Units within the Cardiac portfolio at Medtronic. At CAS, we are developing next generation medical technologies that treat patients with abnormal heart rhythms. Our technologies save lives and improve the quality of living for millions of patients across the world by advancing innovation for the diagnosis and ablation of cardiac arrhythmias and enabling clinicians to...

Within Oncology Regulatory Affairs, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to those who need it – working across our pipeline and the business to get medicines to patients as efficiently and optimally as possible. As an industry leading Oncology Regulatory function, we’re growing fast, and we’re as passionate about and committed to the development of our people as we are our business – providing an open and encouraging space to explore, learn, grow and develop across all roles and levels. At AstraZeneca, we share and are motivated by the same...

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 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. We need...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a CQV & Compliance Lead to join our Team in Raritan, NJ! The Engineering, Maintenance, Facilities and Automation (EMFA) organization provides ownership and oversight for the entire asset portfolio and associated...

Johnson & Johnson is currently recruiting for a Senior Quality Operations Lead! This position can be located in Cornelia or Athens, Georgia. Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinates. At this level, the position has a greater degree of impact on the business results and typically, responsibility for managing a group of professionals. Implement and lead the quality operations organization for the Ethicon Cornelia, Georgia site by Planning, coordinating, and directing quality assurance programs designed to ensure continuous production...

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...

Senior Quality Professional Validation At Molecular Diagnostics, we realize the potential of personalized care as the laboratory’s most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics. Position Senior Quality Professional – Validation Location Molecular Diagnostics Business Unit, Des Plaines, Illinois The Senior Quality Professional – Validation is responsible for ensuring compliance with applicable Corporate and Divisional policies and procedures. This role manages all validation activities, including protocol development, document review, controlled document storage, and resolution of problem reports....

This position of Senior Associate Clinical Quality, works out of our Lake Forest, IL location in AMD , Abbott Molecular Diagnostics. Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions. What you will do Provide global support to Clinical Development (CD) staff to ensure compliance with company policies, GCP regulations/guidelines, ISO standards, and other applicable requirements. Clinical Study Support Act as a reviewer of protocols, informed consent forms, case report forms and other essential study...

Abbott is seeking a Senior Supplier Quality Engineer (SQE) to lead and support supplier quality activities across the product and service lifecycle. This role is responsible for ensuring that suppliers consistently meet Abbott’s quality, regulatory, and business requirements. The Senior SQE will act as a key technical and quality liaison between Abbott and its suppliers, driving continuous improvement, risk mitigation, and compliance with global regulations. This role also supports general QMS processes where applicable, including quality investigations What You'll Work On Lead supplier qualification, selection, and onboarding activities, including supplier risk assessments and quality agreements Develop and maintain supplier quality...

This position works every day on site out of our Carlsbad, CA location in the Cardiometabolic Division in Abbott Rapid Diagnostics. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is 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. What You’ll Work On This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. In addition...

Responsibilities This role is primarily responsible for reviewing data to ensure accuracy, compliance, and completeness within the team or department, while also providing people leadership. Key responsibilities include leading and developing team members, evaluating and interpreting data from various sources, ensuring adherence to regulatory and organizational standards, and identifying trends or discrepancies. The position involves coaching and supporting team members, fostering professional growth, and handling personnel issues as needed. Additionally, this role supports continuous improvement initiatives, prepares technical reports, and collaborates with both internal team members and external stakeholders to resolve data-related issues and maintain high standards of data integrity....

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will leverage your strong applied statistics and IVD expertise to oversee the design, analysis, and interpretation of R&D and analytical validation studies for complex biomarkers used in the detection, monitoring, and management of cancer. PRIMARY RESPONSIBILITIES Lead Biostatistics efforts designing and executing analyses for analytical validation studies in support of CLIA LDT and in vitro diagnostic approvals (e.g., IVDR, 510(k), PMA, etc.). Perform relevant statistical analyses (e.g., sample size, power, agreement, precision, LoD calculations) for validation studies of varying...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Position Overview This position is responsible for developing and carrying out...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly’s Purpose At Lilly, we unite caring with discovery to make...

About This Role As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen’s small molecule portfolio. You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management. This position requires a strategic thinker and strong communicator with deep regulatory CMC expertise who thrives in a global, matrixed environment. What You’ll Do The Associate Director, RegCMC Small Molecule Lead oversees the management and coordination of...

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...

Technical expert that will independently identify, engineer, and optimize new data, software, or technology solutions that address critical business needs. Works with QA Lab Business Owners and the broader BTS organization to improve existing methods and processes. Read and adapt literature and publicly available information to accomplish assignments. Demonstrate proficiency in a broad range of techniques and methods for information technology engineering, including software development, data warehousing, statistics, machine learning, and/or technology infrastructure. Responsibilities Independently design and develop data, software, or technology solutions to answer scientific or business questions. Demonstrate proficiency across a range of technologies related to programming languages,...

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...

This role is responsible for working collaboratively with QA Labs Business Owners, Manufacturing Sites and the broader BTS organization to conceive, design, engineer, and implement data, software, and technology solutions that solve significant scientific or business problems for Quality Labs processes. A successful candidate will develop deep understanding of lab processes to investigate, identify, and implement state-of-the-art technology platforms that drive productivity and efficiency gains in Product Release Testing , Stability Study Operations, and Lab Inventory Management for all AbbVie QC labs. Responsibilities Conceive, design, engineer, and implement data, software, or technology solutions by studying system flows, data usage, and...

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Senior Biostatistician, you will leverage your strong applied statistics background to design and implement statistical analysis and reporting of development and analytical validation studies for complex biomarkers used in the detection, monitoring, and management of cancer. PRIMARY RESPONSIBILITIES With minimal guidance, drive the design and execution of analyses for analytical validation studies in support of CLIA LDT and in vitro diagnostic (e.g., IVDR, 510(k), PMA, etc.). Perform relevant statistical analyses (e.g., sample size, power, agreement, precision, LoD calculations) for studies of varying...

Introduction to role Are you ready to lead strategic communications in clinical drug programs? As an Associate Director in Clinical Regulatory Writing, you'll provide leadership and expertise in authoring high-quality clinical-regulatory documents. Your role will be pivotal in ensuring these documents align with project strategies and regulatory requirements, representing the skill on both drug and non-drug projects. Accountabilities The Clinical Regulatory Writing team is at the forefront of providing expert communications leadership to drug projects. As an Associate Director, you will manage clinical regulatory writing activities across a portfolio, ensuring that documents meet regulatory, technical, and quality standards. You'll lead...

Introduction to role Are you ready to set the global agenda for cyber governance and regulatory adherence within a firm where trusted, protected technology accelerates life-changing medicines to patients? Can you translate complexity into crucial action that protects trust while enabling ambitious innovation and speed? As Executive Director for Global Cyber GRC, you will lead the enterprise approach to information security. You will coordinate technological risk and ensure our most critical data, platforms, and partners operate with resilience, regulatory confidence, and clear accountability. You will connect cyber risk to strategic decisions, equipping the company’s leadership team and Board with sharp,...

QC Chemistry performs testing in support of Framingham Manufacturing. The new Framingham Manufacturing facility is one of the first of its kind worldwide and puts Sanofi at the forefront of bio-manufacturing. The whole industrial process is digitalized, paperless, and is 80 times more productive than a traditional factory. Our Framingham facility leads the way in delivering the next generation of biologics manufacturing. The Team is a diverse group and will be able to offer their own experiences and knowledge that others don’t possess. They communicate openly with each other, sharing their thoughts, opinions, and ideas. They offer each other support...

Specialist Quality Control What you will do In this vital role you will complete and review analytical testing in our cGMP laboratory. The role will be on-site based out of Amgen Rhode Island and will work under the mentorship of the front-line manager. The QC Bioanalytics team provides analytical expertise in testing the following in-process, release and stability samples. The laboratory employs a variety of test methodologies that use sophisticated equipment including HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing. Responsibilities Follow safety guidelines, cGMPs (Good...

Quality Associate Director What you will do Let’s do this! Let’s change the world! In this vital role, you will serve as Amgen’s operations enterprise leader for the Supplier Quality Management (SQM) Quality Management System (QMS) processes. Reporting to the Business Performance & Quality Management System Leader, you will drive the global SQM strategy, lead digital transformation through DQMS and AI-enabled capabilities, and ensure consistent, compliant, and inspection-ready SQM execution across Amgen’s global operations and affiliate network. You will also shape and govern end-to-end SQM processes ensuring Amgen remains aligned with regulatory expectations and positioned for Quality 2032 ambitions. As...

Associate Quality Control What you will do In this vital role you will be responsible for activities including microbiology & analytical testing, sample and data management, as well as equipment and instrumentation operation and maintenance in a highly dynamic, team environment. Responsibilities Perform on site sample collection and sample handling to support GMP operations and Environmental/Water monitoring within Manufacturing clean room and Utility areas. Perform testing and data review for compendia, non-compendia methods, and routine laboratory procedures. Daily review and authorization of environmental and in process batches. Use of testing and data review within automated sampling systems, such as...

2026 Summer Intern - PTQ Quality Processes Department Summary Global Quality and Compliance (PTQ) ensures we deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is a competitive advantage for Roche. You will report to the US Internship Program Manager in the PTQ Quality Process Function. The ideal candidate is a self-starter deeply curious and energized by learning. You should be comfortable with working through ambiguity and are able to prioritize and manage multiple demands and commitments. Your role will be to help Quality Processes fulfill...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. urpose The purpose of the Senior Director – GPS Safety Data...

At Johnson & Johnson Innovative Medicine, we use heart, science and ingenuity to create transformational medicines to improve the health of humanity. Every day, we work to advance scientific research and commercial innovation, to deliver solutions that provide value to patients, physicians and healthcare systems around the world. With a diverse company culture, we celebrate the uniqueness of our employees and are committed to inclusion. We collaborate with the world for the health of everyone in it. Global Regulatory Affairs (GRA) is looking for a high energy, inventive, self-starter intern for its 2026 program. We offer an exciting immersive summer...

We are searching for the best talent for a Senior Manager, Technology Quality – Orthopedics Separation, to be based in Raritan, NJ; New Brunswick, NJ; Horsham, PA; or West Chester, PA. This is an 18-24 month duration-based role. Purpose The Senior Manager, Technology Quality - Orthopedics Separation is responsible for successful execution and implementation of Separated GxP Computerized Systems in accordance with the defined business vision/strategy. Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both...

The position of Program Manager is within our Infectious Diseases business unit located On Site in Westbrook, Maine . 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. In this role, you will manage all aspects of a large scale and complex project, from start to finish, so that it is completed on time and within budget. This role reports into the Program Management Office, and has a...

Instrument Quality Technician Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. Instrument Quality Technician Location South Portland, ME Business Unit Infectious Disease Developed Markets About the Role Join our team as an Instrument Quality Technician and play a key role in serving as an advanced technician supporting the Global Instruments Quality organization. If you're looking for a dynamic role where your contributions will drive the development and manufacture of...

Sr. Hardware Design Quality Engineer Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. The position of Senior Design Quality Engineer is within our Infectious Disease Developed Markets business unit located at San Diego, CA In this role you will actively participate in product development and transfer activities, ensuring product and process conformance to FDA and ISO 13485 standards. This position will review validation methods and protocols, test methods, statistical...

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

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 Director, Regulatory Policy Research and Operations. This position is a hybrid role and can be located in Raritan, NJ or Washington, D.C. The Director, Regulatory Policy Research and Operations...

Specialist Quality Complaints What you will do and what we expect of you In this vital role you will Duties Ensure product complaint records are processed according to FDA guidelines, SOPs and other regulatory agencies’ guidelines; Evaluate subject matter expert assessments; Provide guidance and technical advice to conduct complex complaint investigations, determine corrective actions, and determine steps necessary to ensure the proper level of control for product in distribution; Ensure quality of complaint records and applies analytical abilities to evaluate complex situations using multiple sources of information; Execute against prioritized work plans to ensure timely investigation and closure of...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we are driven by an extraordinary purpose....

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better...

Global Patient Safety, Oncology TA Intern Overview Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. The Global Patient Safety, Oncology Therapeutic Area (TA) Intern will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical industry. The intern will support the enhancement of clinical safety insights by leveraging reverse translatability to improve non-clinical capabilities (e.g. complex in vitro models (CIVM) or...

Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. Intern will be joining the Regulatory Affairs U.S. Advertising and Promotion (USAP) Standards Team. The Standards Team leads USAP through department-wide initiatives, influences process improvements and fosters the review of compliant promotional and R&D communications. Key responsibilities may include Learning the FDA Regulations on Drug Advertising & Promotion Understanding the detailed USAP activities Creating reports, including metrics, department highlights and communications Attending meetings Creating presentation materials...

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

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...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. This This position has the responsibility and authority to support the development and implementation of the overall objectives and long-range regulatory strategies that impact both the introduction of new products and the market status of existing products. The Principal Regulatory Affairs Specialist will exercise a leadership role and serve as a mentor to help develop regulatory depth...

At our Company, we are committed to fostering an inspiring workplace that empowers our employees to innovate and excel. Our Global Workplace and Enterprise Services (GWES) team provides essential solutions that ensure a safe and productive environment, while prioritizing the well-being of our colleagues, communities and the environment, making a positive impact beyond our organization. The Associate Director, Compliance is a leadership role responsible for driving Environmental, Health, and Safety (EHS) compliance and governance across the GWES operating areas in the SE Pennsylvania region. This role ensures reliable, compliant, and cost-effective operations by integrating regulatory requirements into GWES processes, enabling...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview Lilly is currently constructing an advanced manufacturing facility for...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The Senior Director, Pharmacovigilance Project Management (PV PM) is a strategic...

Job Title Quality Manager Our location in Temecula, CA, currently has an opportunity for a Quality Manager (Development) in our Vascular Division. This is an onsite role. This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. 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...

Undergrad Intern - Operations - Quality - Remote (Summer 2026) What You Will Do This internship will be approximately 13 weeks that includes both project-based and experiential learning. In conjunction with the project work, you will have the opportunity for professional development through training sessions, one-on-one mentoring, and various networking events. Operations is one of three foundational functions at Amgen with a mission to manufacture and deliver safe and effective medicine to patients around the world. Operations is divided into the following five sub- functions Supply Chain, Process Development, Quality, Manufacturing, and Facilities & Engineering. We are currently seeking...

Strategic Planning & Operations Sr Mgr - General Medicine, Biosimilars & Regulatory Policy What you will do In this vital role you will partner with other Global Regulatory Affairs and Strategy (GRAAS) Strategic Planning and Operations (SPO) Sr Managers to provide flexible, high-impact support across Amgen’s Regulatory Affairs organization, driving and implementing department goals and initiatives, supporting senior GRAAS leaders in strategic planning and execution of department needs, and collaborating cross-functionally. The primary focus of this role is to support the Biosimilars and General Medicine therapeutic area VP and teams, and the Global Regulatory Policy & Intelligence (GRPI) AVP...

Job Title Quality Engineer Our location in Temecula, CA, currently has an opportunity for a Quality Engineer in our Vascular Division. This is a fully onsite role. The Quality Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. 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...

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...

The Patient Safety Science Therapeutic Area Lead will be responsible for leading and managing a team of scientists within a therapeutic area in the Worldwide Patient Safety organization. This critical role involves ensuring the safety of our medicines through effective pharmacovigilance, pharmaco-epidemiology, and risk management strategies. The role will oversee both pre-marketing and post-marketing product support, ensuring compliance with global regulatory requirements, and driving strategic initiatives to enhance safety science processes. Duties & Responsibilities General Product Scientific Support Partner with fellow Therapeutic Area (TA) Leads and the Head of Patient Safety Sciences to plan, lead, and advance programs and...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly recently announced a $4.5 billion investment to create the Lilly...

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Associate Quality Control What you will do The Associate in Sample Management and Stability is responsible...

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and...

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better...

REGULATORY AFFAIRS SPECIALIST Onsite Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare FDA, European, and Canadian submissions for product changes to ensure timely approval for market release. Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed. Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls....

At Medtronic Neuromodulation (NM) and Pelvic Health (PH), our therapies use advanced stimulation, sensing, software, and digital technologies to restore function and relieve suffering for people living with movement disorders, epilepsy, chronic pain, and pelvic health disorders. Our newest generation of systems can listen directly to neural signals and intelligently adjust therapy in real time — representing a breakthrough era of personalized neuromodulation. In this highly dynamic and rapidly evolving R&D environment, every design decision matters, and the quality of our designs directly influences clinician confidence, patient outcomes, and global healthcare impact. The Design Quality Engineering Director for the Neuromodulation...

Senior Quality Assurance Specialist – NEW Altavista Warehouse (DC) This position works out of our New Distribution Center in Altavista, VA within 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...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we serve an extraordinary purpose. We make...

The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARAD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARAD provides regulatory expertise and guidance on procedural and documentation requirements to all collaborators and cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives globally. Accountabilities Lead and/or contribute to the planning, preparation, and delivery of both simple and complex submissions...

The Sr. Specialist, Quality Assurance is an individual contributor role within the QA Investigations (QAI) team providing quality oversight of Deviation related processes for clinical and commercial Cell Therapy manufacturing at BMS Bothell. This role Collaborates cross-functionally on deviations to ensure accurate root cause analysis (RCA) and corrective and preventive actions (CAPA) have been identified. Ensures the deviation and associated records contains technical merit and completeness according to regulatory expectations. Coaches customers and team members on the deviation process and navigation within the electronic management system. Acts as a Subject Matter Expert in cGMP, GDocP, Data Integrity (DI)/ALCOA+ principles, risk...

The Analyst, Regulatory Policy and Intelligence (RPI) support the US RPI function by conducting research on regulatory intelligence questions and topics within assigned areas and regions. Responsibilities include analyzing and utilizing relevant regulatory approval databases, as well as preparing and delivering regulatory intelligence summaries both orally and in writing. The Analyst should be comfortable working in a dynamic environment and proactively contributing new ideas and process improvements that enhance assigned projects. The Analyst also serves as the office manager for the Rockville MD location and should be comfortable assisting with general office duties. This includes oversight of rental and service...

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...

Responsibilities may include the following and other duties may be assigned. Serves as Subject Matter Expert for Risk Management across the Post-Market space for their assigned product families Accountable for and owns the Risk Management Files for assigned product families within the Robotic Surgical Technologies business. Maintains Risk Management Files for assigned product families Conducts product Risk Analysis (PHA, RAC, SSRCI/System & Use FMEAs) in compliance with ISO14971 Evaluates product Risk Management Files against field data to ensure accuracy and correctness of predicted risks; validating pre-market Benefit Risk Analysis and updating the Risk Management Files...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Join Medtronic as a Senior Quality Program Manager – Quality Core Team Member (QCTM) and be at the forefront of transforming lives through advanced medical technology. In this highly visible role, you will serve as the Quality Core Team Member for...

JOB SUMMARY The Design Quality Engineer Co-Op shares a passion for ensuring the highest quality experiences for our patients and customers. This position will be responsible for the support of Quality Engineering activities pertaining to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the Wound Closure and Healing (WCH) Platform. WCH is a market leader in surgical tissue healing with a broad portfolio including Antibacterial sutures, Knotless Tissue Control Devices, Topical Skin Adhesives, Skin Closure Systems, and traditional absorbable and non-absorbable surgical sutures with innovative needle technologies. DUTIES & RESPONSIBILITIES In accordance with all applicable federal,...

Johnson & Johnson is recruiting for a Sr. Manager, Clinical Quality Risk Management Lead at a MedTech site in one of the following locations Raritan, NJ ; New Brunswick, NJ; Jacksonville, FL; Miami, FL; Cincinnati, OH; Raynham, MA; Santa Clara, CA or Irvine, CA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The Sr. Manager, Clinical Quality Risk Management Lead for Surgery advances the Clinical Quality Risk Management (CQRM) objective,...

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Senior Compliance Engineer located in Santa Clara, CA. At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics and Digital Solutions was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in...

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 Sr. 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. The engineer should excel in an environment...

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate...

About the Role This application is for a 12-week internship role from June - August 2026. Resume review begins in February 2026. The QA Ops intern will partner with MFG on a logbook project for Parenteral Filling (PF) which will include review of the KNEAT logbooks to update the flow and documentation to make them more user friendly and ensure all information is easily captured for review. Additionally this intern will work with Training on QA Shop Floor OJTs to revise and update them to be more user friendly within Veeva. The intern will also look for opportunities to streamline...

We have an immediate opportunity for a Analyst, US Trade Compliance, in our Lake County, Abbott Park, IL location. As the Analyst, your primary role is to conduct audits of Abbott’s U.S. import/export operations to ensure compliance with the applicable U.S. customs regulations. What You'll Work On Perform transactional testing/audits as a member of the US trade compliance audit team. Perform periodic spot checks to assess the timeliness and effectiveness of the site/division post-entry/post-export review processes. Conduct quarterly risk-targeting analysis. Provide analytical support for disclosures and other reporting requirements. Monitor site/division compliance improvement plans to ensure timely implementation and close-out....

Job Title Quality Engineer This position works out of our Liberty, SC location. This is an onsite role . The Quality Engineer is involved in all aspects of the manufacturing operation from assessing equipment needs, to documenting installation, qualification, and ongoing validation of equipment and processes. The Quality Engineer is also expected to assist in the identification and resolution of quality related issues. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. What You’ll Work On Implements Process Monitoring Systems by...

Schedule 5am-5pm (2-2-3 rotation) Major Duties and Responsibilities Quality floor support of complex manufacturing activities Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs. Perform walkthroughs of GMP areas documenting observations and areas of concern. Perform training on routine facility Quality tasks for new team members. Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed. Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines. May support review of quality master data. Authors...

Please note This role does not include direct reports or formal people management responsibilities. Director, Global Customs & Trade Compliance Location New Brunswick, NJ We are seeking a Director of Global Customs & Trade Compliance to lead our customs strategy and ensure adherence to international trade regulations. This leadership position is responsible for driving global alignment, optimizing duty savings, and managing compliance across all our operations. You'll work closely with regional teams to develop and implement effective trade strategies that support our global supply chain. Responsibilities Strategic Leadership Influence and execute the strategic direction for global customs compliance. Process...

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

Reporting to the Sr. Director of QC Operations, the Associate Director of QC operations is responsible for supporting the operations of the internal ddPCR, qPCR and Cell-based assays. The individual will be responsible for supporting all aspects of the laboratory and facility footprint including safety, compliance, instrumentation and equipment qualification and maintenance. Prior experience with laboratory expansion projects is beneficial. This role is responsible for inventory management, raw material procurement as well as the qualification and bridging of critical reagents needed to support internal and external testing at our CMO/CTL partners. The Associate Director of QC Ops is responsible for...

The Manager of Quality Systems Metrics and Management Review is responsible for overseeing and refining enterprise performance review processes, driving effective metric reporting, and leading the automation and modernization of data review mechanisms and data consumption. This role enables leadership teams to make informed decisions through clear, timely, and actionable insights while advancing digital transformation in operational processes. This position defines, implements, and monitors the performance of systems related to quality assurance across global internal manufacturing sites, third-party manufacturers, suppliers, and/or affiliates. Designs effective quality systems, procedures, and/or processes to ensure compliance as well as efficiency throughout the global network....

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...

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly’s Purpose At Lilly, we unite caring with discovery to make...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we unite caring with discovery to make...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we serve an extraordinary purpose. We make...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better...

Career Category Regulatory Let’s do this ! Let’s change the world ! Amgen is seeking a United States Regulatory Lead (USRL) 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 with local laws, regulations, and Amgen...

In this exciting role as an Audit Compliance Manager, you will have responsibility for leading the compliance audit program for the Medtronic Diabetes business. The Audit Compliance Manager is responsible for managing the compliance audit program, for internal, external and supplier audits at the Diabetes sites. This position is an exciting opportunity to work with Medtronic's Diabetes business. This role is instrumental in contributing to defining the direction and plans for process improvement and ensuring the site is audit ready. The individual in this role must be comfortable coaching all employees on audit readiness and working professionally with others to...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Supplier Quality Development Engineering, located in Cincinnati, OH. At Johnson & Johnson Robotics & Digital Solutions, we’re building the future of surgery. Our OTTAVA™ robotic platform unites advanced engineering, digital technologies, and precision manufacturing to deliver next-generation solutions that transform patient care. We are seeking a Supplier Quality Development Engineer to join our rapidly...

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. The Regulatory Compliance, Senior Manager ensures that the organization gains regulatory approval for new products and product amendments, and maintains the currency of product licenses and permits. This role involves monitoring regulatory developments, ensuring compliance, and preparing necessary documentation to support Takeda's mission. How you will contribute As a Regulatory Compliance, Senior Manager in our PDT organization, you will ensure the organization is aware of and compliant with legislation and regulations pertaining to the...

About the role As a Deviation Investigator - Quality Control, you will perform deviation investigations, CAPAs, and change controls through knowledge of quality concepts, investigational techniques, and root cause analysis. You will be responsible for routine monitoring, reporting and escalation of quality performance metrics according to established controlled procedures. How you will contribute Operate Brooklyn Park EQMS (e.g., processing of applicable Help Desk Tickets, Administration of user accounts and EQMS user roles). Monitor the EQMS for compliance with procedures, and completion of deliverables according to committed timelines. Track progress against baseline metrics. Lead Global EQMS projects related to EQMS topics...

Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports. Requires knowledge and technical expertise of Microbiology, regulatory requirements and Global TrackWise system. Understand Regulations and business processes required to maintain Laboratory Data Integrity. Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements. Adhere to cGMP requirements. Adhere to and supports all EHS & E standards, procedures and policies. Responsible for the timely completion of assigned laboratory testing. Ensure that all test equipment is used and maintained correctly. Able to work independently under minimal supervision. Perform environmental...

The Opportunity The Healthcare Compliance Office (HCO) Sr. Compliance Manager Auditing position leads internal compliance audits across Genentech This individual is responsible for conducting complex, in-depth healthcare compliance audits and facilitating corrective action plans within areas of the Genentech organization. This individual designs and effectively executes HCO audits by working closely with other members of the HCO Auditing team or by leading a team comprised of consultants and legal counsel. In the role, this individual Uses knowledge of compliance risks and understanding of database reporting capabilities to develop audit strategies and audit plans Executes routine and ad hoc healthcare compliance...

The Opportunity The Pharma Technical Regulatory - Devices and Combination Products (PTR-DCP) team is seeking a highly motivated regulatory professional with relevant industry experience to join the team. The successful candidate will be responsible for developing and executing regulatory strategies for combination products and standalone physical devices in accordance with domestic and international regulations and guidance. In addition to portfolio-related responsibilities, the individual will play a role to build regulatory capabilities, shape regulatory policy, and establish the necessary device regulatory infrastructures/processes to support our portfolio. What You’ll Do At the Regulatory Program Director level, the individual (a) has in-depth specialist...

At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as a Sr. Manufacturing Quality Engineer to support our capital products line (Automated Impella Controller). In this role, you will have the unique opportunity to contribute to manufacturing life-saving medical devices. As part of our "Patients First!" culture, you will play a crucial role in ensuring the highest quality standards are met to save lives and recover hearts. This position will be located in Danvers, MA. Responsibilities and Duties Provide quality engineering support in the development and manufacturing of...

Objective / Purpose The Head of Global Research Quality holds the highest leadership role within the Research Quality organization and serves as a key member of the R&D Quality leadership team. This executive is fully accountable for defining and executing the global strategic vision for Research Quality, overseeing a global team of experienced subject-matter experts dedicated to ensuring integrity, compliance, and ethical excellence in non-clinical research activities, studies, and processes supporting Takeda’s R&D pipeline. Through strategic leadership, impactful stakeholder engagement, and championing an enterprise-wide quality culture, the Head of Research Quality drives organizational success and reinforces Takeda’s commitment to industry-leading...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. Director, Ethics and Compliance Investigations About the Role The Director, Ethics & Compliance Investigations, plays a key role in promoting Gilead’s culture of integrity, transparency, and accountability. We are seeking a dedicated and experienced investigator to join Gilead’s Ethics & Compliance Investigations team. This position will lead and manage internal investigations into potential violations of law, regulation, or company policy, ensuring that each investigation is handled promptly, confidentially, and in accordance with company policies and regulatory requirements. The successful candidate...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for product market entry. What You’ll Work On Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed. Reviews and evaluates communications to ensure communications convey all necessary...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

The Quality Control Planner is responsible for the oversight of the QC Laboratory Planning and Scheduling within the QC Team. It is also responsible for the procurement of consumables, reagents, and laboratory supplies. Additional responsibilities include short- and long-term forecasting to enable efficient and effective laboratory scheduling, including testing, equipment, and facilities maintenance, as well as other laboratory services coordination. It is responsible for defining laboratory scheduling system as well as identifying continuous improvement opportunities within the planning, procurement, and lab services process. Responsibilities Perform short- and long-term forecast of laboratory demand, including commercial product testing, as well as non-commercial...

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 Sr. Design Quality Engineer role to be located at Danvers, MA. The ideal candidate for the Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a role in product risk management, cybersecurity, change controls, and design controls. This engineer should excel in an environment that embraces...

Purpose The primary responsibility for the Quality Validation Specialis t is the Quality oversight and overall approval of validation and engineering change management activities. The Validation engineering department, will support the implementation of the Validation quality program, and will be expected to independently manage 5+ key projects simultaneously. Responsibilities Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility Executes tasks as required to implement the Validation Master Plan and...

We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to define and implement innovative regulatory strategies toexpeditethe development and approval of our transformative pipeline. You will serve as theglobalregulatoryleadon relevant project teams to formulate and execute development strategies for developmental programs. You will be the primary contact to interface with FDA and will lead cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDAand MAA submissions. Your Role You will work side by side withyour regulatoryand research and development colleagues to develop...

Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the approved marketing applications (MAA/NDA/BLA) and assigned development projects leading to successful preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner. _ Your Contributions (include, but are not limited to) Responsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects Develops CMC regulatory strategies to ensure optimal product development...

Responsible for leading QC deviation, laboratory investigations, CAPAs and change control. May provide support during health agency inspection Shift Available Tuesday- Saturday, Hybrid Evening Shift 300 p.m. to 1130 p.m. Duties/Responsibilities Lead and author QC deviation, laboratory investigations, CAPAs and change control. Work with QC SMEs to conduct root cause analysis. Ensure timely and compliant closure of investigations, deviations, CAPAs and change controls. Perform document revision, project, CAPA and deviation/ investigation, change mgmt. actions, related tasks and/ or continuous improvement efforts. Train and mentor others on deviation, investigation, CAPA and change control process/ procedures. May support health agency inspection as...

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. RayzeBio, a Bristol Myers Squibb company, is looking for a Senior Associate II, Analytical Development at their Indianapolis manufacturing site. The person will be responsible for method development and implementation, method validation, verifications, or transfer, as well as stability...

Summary The Senior Engineer, IT Computer System Validation, Cell Therapy Devens role will provide support to the Digital Plant team at the Devens Cell Therapy Facility (CTF) through managing the computerized system validation (CSV) activities / major projects and supporting deviations and change controls related to computerized systems. This position work closely with the Digital Plant (IT/Automation) subject matter experts and other key stakeholders, such as Manufacturing Science and Technology (MS&T), Quality Engineering (QE), and Manufacturing Operations. Major Duties & Job Responsibilities Gain a thorough understanding of computer systems deployed at Devens CTF. Act as CSV Subject Matter Expert (SME)...

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...