Quality & Regulatory Jobs in Pharma & Biotech

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

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

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

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

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

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

SR ASSOCIATE QUALITY CONTROL I What you will do In this vital role you will be responsible for supporting the Chemistry lab start up and then performing qualification and routine testing to support the Holly Springs Facility. Responsibilities will include writing procedures and reports, executing activities to support initial lab equipment installation, qualification, and validation. Method transfers and training development as well as support of implementation of computerized systems. The Senior Associate QC Chemistry will initially report directly to the Director of Quality Control. This individual will be a subject matter expert on QC Chemistry Laboratory operations and testing....

SR ASSOCIATE QUALITY CONTROL I What you will do In this vital role you will be responsible for supporting the Chemistry lab start up and then performing qualification and routine testing to support the Holly Springs Facility. Responsibilities will include writing procedures and reports, executing activities to support initial lab equipment installation, qualification, and validation. Method transfers and training development as well as support of implementation of computerized systems. The Senior Associate QC Chemistry will initially report directly to the Director of Quality Control. This individual will be a subject matter expert on QC Chemistry Laboratory operations and testing....

Compliance – Strategic Planning and Operations Senior Manager What you will do The Strategic Planning & Operations (SPO) Senior Manager reports to the Director, Strategy, Intelligence, & Innovation and supports planning and operations for the Chief Compliance Officer (CCO) and Worldwide Compliance & Business Ethics (WC&BE) leadership team. The role coordinates leadership routines, planning activities, communications and cross-functional initiatives, maintaining alignment and follow-through across the organization. It works closely with WC&BE leaders and partners while supporting the CCO’s compliance and risk priorities. Key Responsibilities Executive Support and Leadership Cadance Support effective CCO and WC&BE leadership routines and ensure decisions...

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

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

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

SR ASSOCIATE QUALITY CONTROL I What you will do In this vital role you will support ANC QC Sample Management and Stability operations, including site start-up and ongoing program delivery. The role establishes and executes sample-handling and stability processes, coordinates requests and protocol-timed activities, protects sample integrity, and supports laboratory equipment and computerized-system readiness. The role prepares accurately controlled documentation and supports qualified testing, validation, and method or knowledge transfers. It manages routine work with minimal supervision, resolves issues within training and authorization, and promptly escalates complex quality or timeline risks. · Receive, identify, track, store, transfer, retain, and...

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

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

This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Supplier Quality Enginee r II drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You’ll Work On Assess potential new suppliers for technical, quality and...

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

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

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

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

The Triage Order Quality Associate Level II (TOQII) position is responsible for the accurate and timely work of filing insurance claims for Abbott Cancer Diagnostics. This role will demonstrate medical insurance knowledge by determining initial and/or ongoing eligibility, coverage, and related insurance reimbursement order details, including commercial, government, and all various plan coverage. This role will identify order and reimbursement deficiencies, route orders for appropriate actioning and assist with triaging, and document actions taken within the systems for claims lifecycle tracking. This role will be responsible for claims escalations that TOQI are unable to resolve in addition to working “bulk”...

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

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

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

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

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

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

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

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

The Principal Quality Engineer – Digital Regulatory Assurance is responsible for providing regulatory assurance and quality oversight for IT applications, infrastructure platforms, and technology solutions operating within a regulated life sciences environment. This role serves as a senior subject matter expert in Software Lifecycle (SLC) processes, Computer Software Assurance (CSA), infrastructure qualification, regulatory compliance, and quality risk management. The incumbent is responsible for modernization of quality processes through automation, data-driven monitoring, dashboards, and AI-enabled solutions that improve compliance effectiveness, streamline SLC activities, and strengthen inspection readiness. This position bridges implementing regulatory requirements, technology solutions, and improvements to processes by enabling...

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

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

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

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

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

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

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

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

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

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

The Specialist, Quality Systems & Compliance in Device Regulatory & Quality, will be responsible for supporting MDCP Complaints team and other DQ&R Systems tasks and priorities as needed. This position will interact with cross-functional teams and sites. Activities will include review of documentation to ensure compliance with applicable Combination Product or Medical Device Regulations and internal of our company's requirements. In addition, the Specialist is responsible for execution of MDCP projects and support of the device data domain. Primary activities include but are not limited to Review reportable external customer complaints, upon intake, for appropriateness for health authority submission Document...

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

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

The Associate Director is responsible for providing guidance to assure our Manufacturing division product quality complaint management processes are in compliance with worldwide medical device and combination product (MDCP) regulatory expectations. Responsible for a specific area of quality complaint management and serves as the subject matter expert; receipt and handling of product quality complaints, trending and reporting of global product quality complaint and/or Adverse Event Quality Investigation reporting for MDCPs. Maintains awareness of evolving industry and regulatory trends associated with complaint management. Assures strong linkages with other our Company divisions that are the business owners for associated processes e.g. adverse...

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

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

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

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

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

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

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

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

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

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

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The primary focus of the Associate, Quality Control (QC) role will be to perform GMP testing to support product release and...

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

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

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

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

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

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

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

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

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

We are searching for the best talent for Manager, Supplier Quality, Drug Delivery Systems (DDS) , to be located in either Malvern, PA; Horsham, PA; Raritan, NJ or Titusville, NJ. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Purpose The Manager, Supplier Quality, Drug Delivery Systems provides...

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

Our Company has constructed a new manufacturing facility to significantly expand its production capacity. Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our Company’s longstanding dedication to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA)...

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

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

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

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

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

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

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

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

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

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

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

The Associate Director, Clinical Supplies Quality, Global Development Quality provides quality oversight, disposition support, and strategic quality leadership for Clinical Supply Chain activities supporting clinical development programs across the company’s portfolio. The role is accountable for ensuring clinical supplies are available, fit for use, and compliant with applicable regulatory requirements. Key areas of responsibility include U.S. quality operations and disposition, global distribution planning and management, Medical Device/Combination Product supply activities, and acquisition integration. Primary Activities This position requires close, cross-functional collaboration with key stakeholder groups, including Global Clinical Supplies, Global Development Quality, Regulatory Affairs, Device Development & Technology, External Development...

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

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

At AstraZeneca Cell Therapy, we are building the capabilities required to deliver complex, personalized therapies through a highly coordinated, patient-centered operating model. As we strengthen our Vein-to-Vein Operations, we are increasing our focus on standardized execution, patient and product traceability, proactive exception management, operational performance, and quality. The Senior Specialist, Cell Therapy V2V Process Excellence & Quality Operations will support the implementation, standardization, and continuous improvement of scalable Vein-to-Vein processes across the patient and product journey. The role will translate approved operating models and process standards into practical workflows, controlled documentation, performance measures, and improvement initiatives that enable consistent, compliant,...

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

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

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

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

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

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

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

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

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

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

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

We anticipate the application window for this opening will close on - 20 Nov 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Careers that Change Lives This individual will...

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

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

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

Undergrad Co-op - Quality, Manufacturing, Operations and/or Engineering What You Will Do Ready to make an impact? Join us in redefining the world through innovation! We are offering multiple co-op opportunities starting in January 2027. As a co-op, you'll collaborate with cross-functional teams, gaining hands-on experience and advancing your professional skills. You’ll work on meaningful projects and initiatives, contributing to the team’s success while developing your own potential in our Operations organization centralized in Puerto Rico's End-to-End Manufacturing Site. Measure and analyze current system and process performance. Drive improvements in operational efficiency and productivity across the organization, maximizing AI and...

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

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

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

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

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

Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, plays a direct role in treating patients with cancer, respiratory diseases, and autoimmune conditions globally. At FMC, we are committed to delivering life-changing medicines while also creating a workplace where people feel valued and connected. From catered site events and friendly competitions to community outreach, environmental and wellness programs, and team-building activities, we make...

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

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

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

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

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

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

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer - Global Functions for the Innovative Medicine business with responsibilities for areas within the Global Commercial Strategy Organization (GCSO) and IM Business Development. Purpose The Senior Manager will serve as a trusted advisor to the business, providing practical, risk-informed guidance that enables compliant business performance, supports innovation and growth, and strengthens a culture of integrity, accountability, and responsible business outcomes. This role requires a combination of healthcare compliance expertise, strategic business partnership, strong execution, and global stakeholder influence. The Senior Manager, Health Care Compliance...

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

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

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

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

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

Material Compliance Manager What you will do Materials Compliance Manager who will be responsible for Material Approval and Compliance (MAC) that manages the review and approval process to ensure that only compliant messages are communicated to the public. This role will report to the Director or Executive Director of Material Compliance in Regulatory Affairs. The Materials Compliance Manager will manage the materials review process for assigned business units and/or products. The Manager will represent Material Compliance in process discussions with Sponsors and Reviewers and maintains integrity of neutrality while managing needs of all MAC stakeholders. The Manager contributes to...

J Sr Specialist QA - Compliance What you will do In this vital role, you will provide site-level leadership for inspection readiness across both manufacturing facilities, driving a sustained state of readiness for regulatory inspections, corporate and internal audits, and customer audits. You will lead the development and execution of readiness strategies, establish clear governance and accountability, and influence cross-functional partners to identify and address risks before they affect inspection outcomes. As a primary site coordinator, you will oversee inspection logistics including schedules, rooms, escorts, subject matter expert support, document retrieval, communications, and daily inspection management while adapting plans...

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

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

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

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

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

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

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

We anticipate the application window for this opening will close on - 9 Nov 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Working closely with leaders across Quality, Engineering,...

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

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

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

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

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

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

This position works out of our Abbott Park (Lake Bluff, IL) location in the Transfusion Medicine , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Quality Professional will analyze quality standards for components, materials, or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met. What You’ll Work On Design/Change Control - Participating in the development &...

This is not a remote opportunity Must be able to travel up towards 5% The Associate Customs Trade Compliance Analyst supports Abbott's import, export, and Foreign Trade Zone (FTZ) compliance programs by ensuring adherence to U.S. Customs regulations, FDA requirements, export controls, and corporate policies. The role analyzes trade and operational data, conducts compliance reviews and audits, maintains classification and country-of-origin records, and supports customs inquiries and corrective actions. Reviewing import, export, and FTZ transactions for regulatory compliance. Conducting audits, identifying compliance risks, and recommending corrective actions. Maintaining tariff classifications, country-of-origin determinations, valuation data, and trade records. Supporting customs activities...

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

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

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

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

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

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

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Bristol-Myers Squibb Company is hiring a(n) DCM Quality Management - SAP (in Princeton, NJ). Duties Translate business requirements into solutions using...

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

Are you ready to be part of the future of healthcare? Can you think big, be bold, and harness the power of digital and AI to tackle one of the most stubborn problems in regulated software engineering — knowing, with confidence, that what you shipped works? Then Evinova, a health tech business part of the AstraZeneca Group, might be for you. We are building software that transforms clinical trials. Evinova delivers market-leading digital health solutions that are science-based, evidence-led, and human experience-driven. Quality is not a gate at the end of our process — it is embedded in everything we...

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

This position works out of our Scarborough, ME location in the Infectious Disease , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Quality Engineer I role will be responsible for supporting product quality assurance activities, process improvement initiatives, quality system programs, qualification and validation activities, supplier quality management activities, and compliance with applicable FDA and ISO requirements. This position partners with Manufacturing, Operations, Engineering,...

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

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

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

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...

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

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

Purpose Provides leadership and direction in software validation activities including reviewing software requirement documents; writing and reviewing validation documents (test plans/strategy and detailed test cases/instructions); executing and reviewing validation test cases; updating departmental procedures and templates. Responsibilities This position will be responsible to provide validation support for OT projects, primarily DeltaV and/or Allen-Bradley PLCs, and ongoing manufacturing automation validation support activities. Support Factory Acceptance Testing in conjunction with Project Engineers to confirm unit is acceptable. The APC Validation Engineer is responsible for ensuring software quality assurance is achieved during OT projects while meeting project objectives and deliverables. The position is...

Purpose The Senior Manager, Quality provides leadership and direction for the Quality function within Operations. This role is responsible for the effective implementation of AbbVie quality systems within their area of responsibility, including quality oversight of AbbVie-owned warehouses (AP5, AP15, and AP32), the 3PL network, transportation service providers, and quality-relevant suppliers supporting distribution and logistics. Accountabilities also encompass training, regulatory compliance, quality planning, and strategic initiatives. The Senior Manager, Quality leads a team of Quality professionals responsible for compliance and quality oversight across AbbVie-owned warehouses, service providers, and strategic initiatives. This position manages a budget and is accountable for maintaining...

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

Johnson & Johnson is hiring for a Principal Quality Engineer (Design Assurance) to support the Shockwave Reducer business located in New Brighton, MN. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Cardiovascular...

We are searching for the best talent for a Senior Robotics Verification & Validation (V&V) Engineering Manager to join our Orthopaedics team. This is a hybrid role located in Boston, MA . Purpose The Senior Robotics Verification & Validation (V&V) Engineering Manager is responsible for ensuring that robotic products meet all defined system and subsystem level requirements and are safe, effective, and compliant for their intended clinical use. This role plays a critical part in supporting regulatory submissions and product releases by planning, executing, and documenting comprehensive V&V activities in accordance with FDA regulations, ISO 13485, IEC standards, and other...

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

Key Responsibilities QC Strategy & Operations Lead and oversee all Quality Control functions at the site, including analytical, microbiology, raw materials, in-process, drug substance, drug product, and stability programs across small molecule and biologics platforms Define and execute the site QC strategy, aligned with global quality and business objectives Ensure effective support of commercial manufacturing, PPQ, technical transfers, and new product introduction Ensure QC operations meet global GMP requirements and maintain a continuous state of inspection readiness Represent QC during regulatory inspections and audits, ensuring strong compliance and data integrity standards Technical Capability Strengthening & People Leadership Build and strengthen...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The GRS-CMC Director is responsible for overseeing management of multiple development and life-cycle management projects of varying priorities and complexities. Represent...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The BMS Global Regulatory Sciences Summer Intern Program is your chance to step inside one of the world's leading biopharmaceutical...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Patient Safety Intern will gain hands-on experience across multiple areas of pharmacovigilance and drug safety while supporting strategic initiatives that...

Quality Assurance Senior Manager What you will do This QA Sr. Manager role will be responsible for the quality oversight of primary component suppliers. This person is an integral member of the Amgen cross-functional supplier team(s) that includes, but is not limited to, business operations, process development, supply chain and combination product quality. Key Responsibilities Act as the quality lead for supplier relationships, from onboarding through disengagement, ensuring performance through robust proactive monitoring, technical site visits, and continuous improvement. Perform proactive quality management of suppliers, ensuring compliance with global regulatory standards, including but not limited to GDP, GMP, ISO,...

Senior Associate Quality Control What you will do In this vital role, under minimal supervision, you will be responsible for activities including Raw Material testing using sophisticated instrumentation, such as HPLC, GC and GC-MS, sample/data management and equipment/instrumentation operation and maintenance in a highly dynamic, team environment. Responsibilities include Perform testing methods including HPLC, GC and GC-MS Perform testing and data analysis for compendia, non-compendia methods, and routine laboratory procedures Perform routine and non-routine evaluations and data review Generate accurate and concise laboratory documentation using electronic systems and notebooks Operate and maintain specialized laboratory equipment and instrumentation Participate in...

Specialist, Quality Control Analytical, Cell Therapy Wednesday - Saturday (4x 10 hour day shift) Role Overview - Rockville, MD The Specialist, QC Analytical, performs routine and non-routine analytical testing to support cGMP lot release and stability of cell therapy products. The role executes approved methods (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell-based assays) with high quality and data integrity, maintains accurate documentation, and participates in laboratory investigations. The QC Specialist collaborates within the QC team and with cross-functional partners to meet testing timelines and ensure compliant operations. This position is for a 4 days per week,...

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. The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life...

Associate Director – Validation Tarzana, California Job Summary The Associate Director – Validation is responsible for leading and managing the validation program within the Facilities and Engineering department supporting validation needs site wide, including Site and Project Validation Master Plans, facility and equipment commissioning / qualification / validation (CQV) processes, equipment life cycle validated status assessments, validation documentation packages, and compliance with cGMP regulations within a pharmaceutical organization. This role involves providing expert technical guidance, overseeing complex projects, and ensuring that all systems and processes meet regulatory requirements and support operational efficiency. Key Responsibilities Validation Program Leadership and Oversight Establish...

Location San Diego, CA. Not remote. We are hiring a Senior Staff AI Engineer to set the technical direction for quality engineering across Illumina's enterprise platforms, with AI agents doing a growing share of the testing work. You will be the most senior individual contributor in QA you design the test architecture, lead our Tricentis platform, and make agentic testing safe enough for regulated, GxP-relevant systems. Technical leadership of 10-20 QA and automation engineers across vendors and teams. The role sits in Enterprise AI and partners with Data Engineering, application teams (SAP, Salesforce, ServiceNow, Workday, M365) and Quality &...

Role Overview The Associate Director of Regulatory Operations Content Management will serve as a strategic business partner and subject matter expert (SME) supporting the advancement of Regulatory Operations capabilities across submission planning, content management, and registration management within a dynamic digital and AI-enabled pharmaceutical environment. This role will partner closely with Regulatory Affairs, CMC, Quality, IT, Supply Chain, and global business stakeholders to support operational strategy, digital transformation, process optimization, and scalable regulatory execution across multiple therapeutic modalities and organizational functions within Reg CMC. The ideal candidate combines strong CMC operational expertise with sound business judgment, effective communication skills, and...

This position supports our Madison, WI locations within the Cancer Diagnostics business. As an Associate Quality Assurance Engineer, you’ll partner with Operations to help ensure manufacturing processes, materials, and products meet quality and regulatory requirements. You’ll support validation and qualification activities, investigate quality issues, review production documentation, and assess materials for commercial release while contributing to process improvement and operational excellence. What You’ll Work On Partner with Operations as a Quality representative to review production records, executed test methods, and material disposition decisions before commercial distribution. Review process and test method validation, equipment and facility qualification documentation, and calibration records;...

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

Participates in clinical and nonclinical regulatory strategic discussions, supports multiple products’ clinical trial and registration and activities. Responsible for cross-functional execution of regulatory activities at the team level to support assigned programs and markets. Supports the implementation of regulatory strategy for assigned markets & provides regulatory support for the registration/post-licensing activities of medicinal products. Maintains and develops knowledge of assigned market regulatory procedures. Builds/maintains relationships within GRA & other stakeholders to support effective communication & efficient implementation of regulatory activities for assigned markets & activities. The Opportunity to Make a Difference Acts as the regulatory affairs clinical lead for clinical...

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

We are searching for an HR Leader, Global Quality & Regulatory Affairs to be located in Warsaw, IN, Raynham MA, West Chester, PA, Palm Beach Gardens, FL, or Raritan, NJ. The HR Leader, Global Quality & Regulatory Affairs is responsible for setting and leading the people strategy, design, governance, and delivery of HR programs supporting this global organization. Reporting to the Head of HR for Global Quality, Regulatory & Patient Safety, this role serves as a strategic partner to the Global Quality team to drive talent outcomes aligned to business priorities. The role provides leadership across talent strategy, organization effectiveness,...

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

Key Responsibilities GMP Operations Quality Oversight · Provide Quality Assurance oversight of GMP Manufacturing and QC testing operations through the product lifecycle from master cell bank to drug product. · Provide Quality Assurance strategy and oversight of external QC laboratories, ensuring method lifecycle activities (qualification, verification, and validation) are executed in compliance with cGMP, ICH, and internal quality standards, with appropriate review and approval of protocols, reports, and methods. · Review and approve laboratory investigations (e.g., OOS/OOT/deviations) conducted by contract partners, ensuring thorough root cause analysis, robust corrective and preventive actions (CAPA), and aligned decision-making impacting product quality and disposition....

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

The Director, Quality Risk Management (QRM) is an enterprise Quality leader responsible for defining, governing, and advancing the global strategy for Quality Risk Management across the organization. This role actively supports the Executive Director of Risk and Proactive Quality and has direct leadership accountability for the Quality Risk Management process across PDM. This leader provides strategic direction and oversight to ensure that QRM principles, risk‑based thinking and proactive quality approaches are deeply embedded across the Pharmaceutical Quality System (PQS) and operations. The role is accountable for designing, implementing, and sustaining compliant, scalable, and efficient global processes that enable early risk...

The Senior Manager, Design Quality is a hands-on Quality leader who combines supervisory responsibilities with direct Design Quality support for product-development programs. The role leads and develops a team of Design Quality professionals while partnering with Product Development to establish fit-for-purpose Quality strategies, identify and address risk early, and ensure development decisions are supported by appropriate technical evidence and rigor. Responsibilities The Senior Manager is accountable for effective Design Quality execution across assigned programs, including product risk management, design controls, verification and validation, design transfer, process validation, change management, and resolution of product quality issues. The role provides direct technical...

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

Quality Compliance Program Manager This position works out of our Plymouth, MN location in the Electrophysiology division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies, allowing people to restore their health and get on with their lives. As the Quality Compliance Program Manager , you will partner with leaders across manufacturing, quality, regulatory, and commercial functions to drive key compliance initiatives, strengthen audit readiness, manage critical quality programs, and influence the future of our quality culture. The role also includes leadership of audit readiness, field actions, standards and regulation change management, certificate management, and...

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...

We anticipate the application window for this opening will close on - 31 Dec 2026 Position Principal Quality Engineer for Medtronic, Inc. in Grand Rapids, MI. Responsible for products in the form of finished medical devices by supporting manufacturing operations and evaluating compliance of materials and processes with product specifications, regulatory requirements, and customer requirements. Coordinate Quality Engineering for medical device components, ensuring that all finished good and processes meet specifications. Leverage Good Manufacturing Practices (GMP) standards, navigate government and medical device regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, EU Medical Device Regulation...

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