Quality & Regulatory Jobs in Pharma & Biotech

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

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

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

The Senior Director, Global Regulatory Strategy Lead and FDA Regulatory SME is responsible for oversight of complex product development within and across Therapeutic Areas and provides FDA-specific subject matter expertise at the intersection of FDA regulations, guidances, policy, and product development strategy, while supporting global regulatory strategy. Develops and implements global regulatory strategies to secure and maintain market approval. The Senior Director FDA Regulatory SME ensures strategic messaging in US regulatory dossiers, provides consultation and direction on compliance with US regulatory requirements. Reviews regulatory documentation for compounds through all phases of development, including post-approval, and recommends acceleration strategies, all while...

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

J&J MedTech is recruiting for a Primary Quality Engineer New Product Innovation & Lifecycle Management (NPI/LCM) to join our Aesthetics & Reconstruction (A&R) organization located in Irving, Texas . Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The Primary Quality Engineer NPI LCM is responsible for supporting product quality and reliability ensuring the implementation of ground-breaking technology for medical devices is safe, effective, and follows applicable regulations, standards, and industry practices. Working...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for an Associate Director, Regulatory Affairs, North American Regional Leader (NARL) to be located in Spring House, PA or Raritan, NJ. Purpose The Associate Director, Regulatory Affairs, North American Regional Leader ,...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer within North America MedTech. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Purpose This role will support the Robotics & Digital business by serving as a strategic advisor and trusted business partner on healthcare compliance matters. The successful candidate will partner closely with commercial, medical, and functional leaders to enable compliant business growth while maintaining...

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

Johnson & Johnson is currently seeking a Director, Enterprise Regulatory Compliance, to join our Enterprise Regulatory Compliance Assessment team, located in New Brunswick, Raritan, Titusville, NJ and Horsham, PA. The Director, Enterprise Regulatory Compliance reports to the Senior Director, Head of Assessment, Enterprise Regulatory Compliance, and serves as an enterprise point of contact for cGMP regulatory compliance matters across Medical Devices and Pharmaceuticals. This role provides independent oversight of compliance risks and trends, partners with Quality and Compliance, and Regulatory Intelligence leaders to identify and mitigate emerging risks and delivers clear insights to senior leadership to support sound, risk-based decisions....

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

An engineering professional that works with project owners, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The main objective is to establish evaluation, testing and documentation for risk management, commissioning and validation applying product and regulatory requirements and risk management to result in robust, high quality products. This includes optimizing systems that support the work in and around this area of responsibility. Responsibilities...

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

Location Gaithersburg, Boston, Santa Monica, South San Francisco Hybrid 3 days in office Are you ready to contribute to setting the global regulatory vision for pioneering cell therapies and turn breakthrough science into real options for patients? This role supports high-impact programs across cancer, immune-mediated and rare diseases, guiding regulatory delivery and project management for projects spanning early development through licensure. You will work hand in hand with the global regulatory strategy teams in a dynamic environment, to advance complex cell therapy programs. By being responsible for project management and process activities, you will contribute to effecting high stake's engagement...

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

Position Overview The Sr. Specialist Digital and Data Quality will be responsible for the quality aspects of GMP computerized systems and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations. This includes involvement in all quality-related activities for computerized systems which are required by our Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety or data integrity. The position will work closely with stakeholders and SME’s from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight...

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

We anticipate the application window for this opening will close on - 4 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Medtronic Mindset challenges us to act...

We anticipate the application window for this opening will close on - 10 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Senior Regulatory Affairs Specialist will play...

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

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

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

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

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Specialist, External Quality (Synthetics)! This position can be performed at Raritan or Titusville, NJ, Malvern, Spring House or Horsham, PA & Athens, GA. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer to be based in Titusville, NJ. Purpose The Senior Manager, Health Care Compliance Officer serves as a strategic healthcare compliance partner to Johnson & Johnson Innovative Medicine teams, enabling compliant growth through risk-based, principles-driven guidance and decision support. This role operates within a dynamic and highly regulated environment, translating evolving legal, regulatory, and policy requirements into clear, practical, and actionable guidance that supports both business objectives and ethical standards. Consistent with the Innovative Medicine compliance strategy, this position helps advance the evolution from a rules-based...

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

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

Use Your Power for Purpose Our dedicated manufacturing logistics and supply team ensures that customers and patients receive the essential medicines they require precisely when they need them. By embracing challenges, envisioning new possibilities, and taking decisive action, you will contribute to delivering medicines to the world with greater speed and efficiency. What You Will Achieve In this role, you will Plan and manage the efficient flow of products and services through the Pfizer supply chain cycle, ensuring compliance with in-country and international regulations. Ensure efficient operations by maintaining proper system interfaces between Pfizer and other required parties, monitoring the...

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

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

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

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

We anticipate the application window for this opening will close on - 1 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Across our global Neuroscience organization, we advance...

We anticipate the application window for this opening will close on - 31 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Principal Supplier Quality Engineer for New...

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

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 Education Bachelor’s degree in engineering required. Experience Minimum of 4 years of relevant engineering, quality, or manufacturing experience required; or a master’s...

We anticipate the application window for this opening will close on - 29 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we bring bold ideas forward...

We anticipate the application window for this opening will close on - 1 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life As one of three comprehensive portfolios ...

At AstraZeneca Cell Therapy , we are building the capabilities required to deliver complex, personalized therapies through a highly coordinated, patient-centered, and globally scalable supply chain. In cell therapy, every movement matters. The reliable and compliant flow of patient materials, critical manufacturing inputs, intermediates, and finished product is essential to protecting product integrity, supporting manufacturing continuity, and helping therapies reach patients on time. The Senior Specialist, Cell Therapy Trade Compliance – Free Trade Zone Operations plays a critical role in that mission by leading Free Trade Zone (FTZ) operations at AstraZeneca’s cell therapy manufacturing sites . This role helps ensure...

As the Sr. Specialist Quality Engineering (QE) you will be responsible for the oversight of the Quality Risk Management, CQV, CSV programs for the Cell Therapy operation of the Tarzana facility. This includes Quality Review and Approval for including Quality Risk Assessments, Technical Reports, Validation Planning, Change Controls, Validation Protocols, Reports, as well as leading the technical quality arm of the Quality department. You will ensure that operations are compliant with the cGMP standards established by AstraZeneca and relevant regulatory agencies. Responsibilities You will provide leadership, direction and mentoring to ensure that the QE organization is successful in meeting the...

Senior Director, Quality Are you ready to pioneer a modern Quality mindset that safeguards patients while accelerating delivery? As Senior Director, Quality for our Mount Vernon site, you will lead the end-to-end Quality function that releases every batch, from raw materials to finished product, ensuring cGMP compliance and reliable, quality supply to patients. In this high-impact role, you will set the vision and standards for a functionally independent Quality unit, steer regulatory and compliance strategy, and partner closely with manufacturing and supply leaders to deliver safe, effective medicines with confidence. You will coach and empower a large, multi-disciplinary Quality team,...

Sr. Quality Technician Senior Quality Technician responsible for bioanalytical and/or platform quality testing within the WWLIMS or QIMS system and SAP system. Provides inputs to facilitate CAPA investigations as required. Will be required to own and approve any testing events. Maintains product and testing inventory and complies with the quality system. Undertakes the role as Senior Quality Technician and executes daily activities with minimal supervision. Becomes a point of contact for lab issues and may be called on to aid with scheduling activities. Provides input on testing and is an SME (Subject Matter Expert) on their certifications. May provide...

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

SR. ASSOCIATE QUALITY CONTROL I What you will do In this vital role you will perform routine Microbiological testing and provide technical support for Environmental Monitoring and Utilities Monitoring programs, working at a Drug Substance manufacturing facility. The Senior Associate, Quality Control Microbiology will report directly to the Senior Manager of Quality Control Microbiology. Perform routine microbiological testing, including but not limited to endotoxin, bioburden, TOC, conductivity, and microbial identifications. Support sample type validation testing for microbiological assays as needed. Perform data review for activities performed within the Microbiology department. Assist EM and Utilities Program owners in tracking and...

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

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

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. This role will primarily support the Services IPT (Integrated Process Team) as well as Engineering and Maintenance at the Elkhorn...

Employer Bristol-Myers Squibb Company Senior Engineer, IT Laboratory & Quality Systems, Devens Biologics Digital Plant Location 38 Jackson Road, Devens, MA 01434 Wage Range$126,859.00 - $133,630.00 Bristol-Myers Squibb Company is hiring a(n) Senior Engineer, IT Laboratory & Quality Systems, Devens Biologics Digital Plant (in Devens, MA). Duties Ensure secure administration of documentation, processes of benchtop equipment, lab, and quality systems. Provide end-to-end management within BMS systems to support changes, incidents, problems, and asset management and ensure completion within defined timeframes. Conduct assessment of system reliability. Act as plant subject matter expertise (SME). Ensure application configurations, data integrity, and cyber...

FACILITIES COMPLIANCE MGR ENGINEER What you will do In this vital role you will ensure facility systems, maintenance programs, engineering activities, and quality processes consistently meet cGMP requirements, Amgen standards, and global regulatory expectations. In this critical role, you will partner across Facilities & Engineering, Manufacturing, Quality, Validation, Environmental Health & Safety, Supply Chain, Digital Technology & Innovation, and Capital Projects to ensure engineering activities support operational excellence while maintaining a constant state of inspection readiness. The successful candidate will demonstrate strong engineering judgment, ownership, technical leadership, and a continuous improvement mindset while driving compliance, reliability, and exceptional customer...

Manager Quality Control – Incoming (2nd Shift) What you will do Let’s do this. Let’s change the world! In this vital role, you will be responsible for overseeing and managing the Incoming Raw Material Sampling and Inspection process to ensure that all raw materials and components meet the established quality standards before they are used in our production processes. This role will lead a team of quality control associates to maintain the highest standards of quality and reliability for our raw materials. Specific responsibilities include but are not limited to Develop and maintain standardized inspection and sampling procedures/documents for incoming...

Senior Associate Quality Control What you will do Let’s do this. Let’s change the world! In this vital role, you will support Sample Plan templating, logging and compilation of LIMS packets needed to support manufacturing Hosting and participating in cross-functional, cross-site, and external meetings to support internal and external testing. Management support of Contract Laboratory testing as required to support the manufacturing of Amgen products to ensure testing is completed on time per Quality Agreements and Disposition Due Dates. Support includes tracking of samples, data entry and issue resolution. Certificate of Analysis generation and Lot tracking for testing that supports...

We anticipate the application window for this opening will close on - 31 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Senior Supplier Quality Engineer for New...

We anticipate the application window for this opening will close on - 30 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life This role will be responsible for processing...

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

Johnson & Johnson is currently recruiting for the best talent for a Lead, Technology Compliance to be located in Raritan, NJ, Horsham, PA, New Brunswick, NJ or Beerse, Belgium. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) North America- Requisition #R-089703 EMEA– Requisition# R-090248 The Lead, ERP & WMS Technology Compliance is responsible for execution and operational support of...

Regulatory Affairs Specialist II This position works out of our Lake Forest, IL location in the Core Lab Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Regulatory Affairs Specialist II is responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day-to-day activities for change control. Provides regulatory directions on team activities. Apply basic regulatory understanding to support product and...

This is a Pipeline requisition, to source candidates for future opportunities in 2026-27. As a global leader in Medical Devices Technologies. Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. What You’ll Do Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Learns to identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by disposition of non‐conforming material, assessing in identification of primary root causes and understanding corrective and preventive actions. May be responsible for working with process owner to bound product stops and document release criteria. Assists...

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

This position works out of our Barceloneta location in the AV division at first shift-8am-5pm . As a global leader in Medical Devices Technologies. Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. What You’ll Do Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Learns to identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by disposition of non‐conforming material, assessing in identification of primary root causes and understanding corrective and preventive actions. May be responsible for working with process owner to bound product stops and document release criteria....

We anticipate the application window for this opening will close on - 8 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life As one of three comprehensive portfolios ...

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

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

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

We anticipate the application window for this opening will close on - 31 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life In this exciting role as a...

We anticipate the application window for this opening will close on - 29 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we A career at...

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

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

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to Career development with an international company where you can grow the career you dream of . Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year An excellent retirement savings...

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

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

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

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

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

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

Abiomed is recruiting for a Sr Manufacturing Quality Engineer located in Danvers, MA . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as a Sr. Manufacturing Quality Engineer to support our facilities expansion. In this role, you will have the unique opportunity to contribute to manufacturing life-saving medical devices....

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

We are searching for the best talent for a Quality Engineer to be based in Jacksonville, FL. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Purpose The Quality Assurance Engineer assists with quality events, nonconformances, and associated tasks at our Jacksonville Manufacturing site. They utilize Quality Engineering tools and practices to effectively and efficiently manage nonconformances and ensure key metrics are met. They coordinate phases of work internally and externally....

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at 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...

Johnson & Johnson is currently recruiting for an Innovative Medicine Transformation IT Compliance Senior Manager (Transcend Program) and the role will be based in Titusville, NJ and other J&J offices. 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...

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

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

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. Based in Santa Monica, CA or Gaithersburg, MD, you will shape end-to-end CMC regulatory pathways across development stages, partnering closely with technical, clinical, and quality leaders. How will you apply your expertise to anticipate risk, set clear direction, and drive rapid, global approvals for a growing pipeline?...

Use Your Power for Purpose The Rochester Senior Validation Engineer is responsible for planning, scheduling, executing and leading various validation project assignments such as qualification, validation, and requalification activities related to manufacturing process, equipment, critical utility systems, product, cleaning, and/or sterilization processes. This role will also be responsible for the development/authoring of project plans, protocols, test scripts and reports throughout all life cycle of the process from initiation to continuous monitoring. The position will work closely with area owners and suppliers to finalize validation/qualification requirements for process, equipment and systems, ensuring that company policies, procedures, applicable regulations and guidelines are...

We anticipate the application window for this opening will close on - 28 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life This position will support the Surgical...

This is an exciting opportunity to independently lead Biostatistics efforts advancing Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics expertise to drive the strategy and execution of complex validation experiments for multiple high-priority projects. The ideal candidate will possess exceptional communication skills and a deep understanding of Biostatistics in analytical validation. PRIMARY RESPONSIBILITIES Strategic Study Design and Analysis Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products. Cross-Functional Leadership Serve as the statistical lead on multiple high-priority project teams. Partner with bench...

This is an exciting opportunity to independently lead Biostatistics efforts advancing Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics expertise to drive the strategy and execution of complex validation experiments for multiple high-priority projects. The ideal candidate will possess exceptional communication skills and a deep understanding of Biostatistics in analytical validation. PRIMARY RESPONSIBILITIES Strategic Study Design and Analysis Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products. Cross-Functional Leadership Serve as the statistical lead on multiple high-priority project teams. Partner with bench...

Position We are seeking an experienced and dynamic Director, Auditor, Clinical Quality Assurance tolead our GCP auditing efforts. The successful candidate will play a pivotal role in ensuring thatour clinical trials adhere to Good Clinical Practice (GCP) guidelines and maintain the highest standards of quality. This includes internal audits, site audits, and vendor audits. This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices. About You You are an expert-level auditor with the discipline and consistent follow-through to see complexaudit...

The Director, US Advertising and Promotional Compliance, will serve as the therapeutic area lead and the Regulatory Affairs (RA) representative for assigned products. They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness and public affairs communications. The Director will also engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional material. The Director will also act as the primary liaison with FDA on ad/promo regulatory issues concerning promotional materials. Accountabilities Reviewing...

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...

The Director, US Advertising and Promotional Compliance, will serve as the therapeutic area lead and the Regulatory Affairs (RA) representative for assigned products. They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness and public affairs communications. The Director will also engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional material. The Director will also act as the primary liaison with FDA on ad/promo regulatory issues concerning promotional materials. Accountabilities Reviewing...

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

We anticipate the application window for this opening will close on - 10 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Interventional Cardiology Therapies (ICT) portfolio provides...

We anticipate the application window for this opening will close on - 31 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Business Group Global Quality / Enterprise Quality...

Schedule This onsite position operates on 10-hour shifts from Sunday through Wednesday during the first shift (8AM-6PM), with some occasional support required outside of those hours. About This Role We are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at RTP drug substance manufacturing facility. The Sr. Associate I is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Associate I performs and trains other team members on the microbial testing of all in-process drug substance, EM/UM, and raw materials samples. Additionally this...

About the role Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review where you will be working on the US Medical team. In this role, you will be empowered to serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. You will contribute to Takeda’s mission by providing regulatory strategic oversight for complex products or therapeutic area products to help ensure regulatory compliance of promotional materials generated for assigned US products and/or compounds. How you will contribute Be an internal expert on FDA regulations, guidance, and...

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

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Director, Clinical Program Quality & Excellence (CPQE), Oncology based in Cambridge, MA reporting to the Head, Clinical Program Quality Oncology . At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which...

Job Title Manager, Regulatory Compliance This position works on site out of our Plano, TX site supporting the Neuromodulation division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. The Regulatory Compliance Manager is responsible for ensuring the organization’s medical devices comply with applicable global regulatory requirements and industry standards throughout the product lifecycle. This role oversees compliance programs, recalls/field actions, drives regulatory intelligence, drives implementation of regulatory and standards changes...

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 Officer, Global...

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

Johnson and Johnson Innovative Medicine, is recruiting for a Senior Quality Lead! This position will be located in Malvern, PA, with considerations given to Spring House, PA. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at On this team, we provide end to end quality oversight of GMP...

Johnson & Johnson MedTech, Electrophysiology, is recruiting a Preclinical Compliance Associate This position is located in Irvine, CA and will be following a hybrid model. 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. Fueled by...

Under general supervision, participate in new and sustaining product/process teams to support design verification tests, process validations, quality processes. Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards. As needed, assists to develop quality-engineered systems and products, and support qualification and validation activities. Will work on complex problems and projects. Will show leadership by innovating compliant approaches and solutions to problems. Will receive technical guidance on sophisticated problems, but independently develops...

Specialist Quality Assurance (Second Shift) What you will do Let’s do this. Let’s change the world! In this vital role, you will serve as a Quality leader accountable for the investigation and resolution of minor deviations, safeguarding product quality and patient safety through sound judgment, strong ownership, cross‑functional collaboration, and effective risk management in a dynamic drug product manufacturing environment. Specific responsibilities include but are not limited to Serve as Quality investigation lead and decision-maker for complex deviations, maintaining accountability for designation, documentation quality, timeliness and closure. Actively participate in deviation meetings, managing multiple concurrent deviations and driving effective resolution....

Regulatory Affairs Director - Inflammation and Rare Disease What you will do Amgen is seeking a Regulatory Affairs Director supporting products in the Inflammation and Rare Disease Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this vital, product-facing role you will lead the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The role of the Regulatory Affairs Director is to lead GRTs within Amgen’s GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive...

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

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

Expected Areas of Competence Develop and lead Global and US Regulatory activities for a Development Team (s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement. Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans Provide leadership to resolve critical regulatory project issues, bring the appropriate regulatory experts together as needed Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders Develop registration strategy for a product, and translate that into operational...

We anticipate the application window for this opening will close on - 31 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life A DAY IN THE LIFE The Senior...

Are you passionate about ensuring measurement accuracy, laboratory compliance, and the integrity of test data used to support the development and commercialization of innovative medical devices and combination products? Join our Device Development & Technology (DD&T) organization as a Metrologist & Compliance Lead supporting our laboratories including an ISO 13485-certified Design Verification Laboratory. This role is responsible for maintaining laboratory measurement systems, calibration programs, equipment qualification and computer system validation activities, and quality system compliance to ensure reliable, traceable, and regulatory-compliant test results. The Metrologist & Compliance Lead serves as a technical leader for laboratory metrology practices and quality compliance...

Senior Quality Engineer Duties Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for combination and non-combination products associated with Combination Product Operations activities; Ensure that the Quality Systems in place for Amgen products are appropriately scoped and followed; Provide quality oversight for device and combination-product related design controls per FDA (Food and Drug Administration) CFR (Code of Federal Regulations) 820.30 and 21 CFR Part 4, CAPA (Corrective and Preventative Actions), RCA (Root Cause Analysis), Change Controls, product complaints investigations, and other assignments as given; Manage low to moderate complexity programs such as automating team activities...

Sr Mgr Quality Assurance – Major Deviations Lifecycle Team What you will do In this vital role you will be responsible for leading the Major Deviations Team and ensuring the timely, compliant, and effective management of significant quality events across manufacturing, packaging, laboratory, and support operations. This role provides strategic oversight of deviation investigations, root cause analyses, risk assessments, corrective and preventive actions (CAPAs), and regulatory compliance activities to ensure product quality and patient safety. The Senior Manager partners cross-functionally with Quality Assurance, Quality Control, Manufacturing, Engineering, Supply Chain, Regulatory Affairs and Compliance, Process Development, Environmental Health and Safety,...

Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. Assures that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual has responsibility for products/multiple driver indications for a product within a Therapeutic...

The Senior Quality Engineer, Cybersecurity is a hands-on individual contributor and subject matter expert who bridges quality engineering and cybersecurity across Verily's consumer, research, and medical device (SaMD) product portfolio. This role champions quality and security throughout the software development lifecycle — partnering closely with engineering, security, and product teams to ensure that cybersecurity processes are embedded in the QMS, meet applicable regulatory requirements, and scale across Verily's evolving product domains. The role proactively identifies risk, drives cross-functional initiatives, and brings deep technical fluency in both quality engineering and cybersecurity to protect the integrity of Verily's systems, data, and regulated...

The Quality Systems and Compliance Lead drives quality excellence at Verily by owning one or more Quality Assurance domains and leading strategic QA initiatives with measurable impact. This role is responsible for designing and advancing robust quality systems and serves as a key liaison across engineering, product, and operations teams — ensuring that products spanning consumer health, research tools, and medical devices are developed, commercialized, and sustained to the highest standards of quality, reliability, and regulatory compliance. R esponsibilities Leads the ongoing vision and implementation of the Quality Management System (QMS) — spanning consumer, research, and medical device (SaMD) quality,...

The Regulatory Compliance Lead is a technically grounded individual contributor responsible for developing and maintaining fit-for-purpose regulatory compliance frameworks across consumer, research, and medical device (SaMD) product areas. This role partners closely with engineering and product teams to operationalize US regulatory requirements — with an eye toward ex-US expansion — leveraging tools such as Jira, GitHub, and document control systems to embed compliance into the product development lifecycle. R esponsibilities Develops and maintains fit-for-purpose regulatory compliance frameworks for consumer, research, and SaMD products, including AI/ML-enabled and generative AI applications, in alignment with applicable US regulations and with an eye toward...

The Rahway based Senior Specialist, Global Development Quality Operations – API , is responsible for independent approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release, and maintenance in support of our company's clinical supply programs. This person will also independently approve documentation accompanying the disposition of API materials to ensure conformance to appropriate regulatory and company requirements. In support of clinical supply manufacture and/or inspections independently perform or coordinate routine and specialized audits of audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure compliance with Standard Operating Procedures (SOPs),...

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

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for QA Manager, Parenteral to be located at Gurabo, PR. The Quality Assurance (QA) Manager, Parenteral is accountable for providing technical knowledge, direction, and support of assigned products including areas such as...

Johnson & Johnson MedTech, Electrophysiology, is recruiting a Manager, Contract Performance & Compliance. This position will be preferably based in Irvine, CA, however remote opportunities may be considered. 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....

Job Title Development Quality Engineer Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. This role is fully onsite. What You’ll Work On Provides technical assistance to engineering to support manufacturing efforts by implementing corrective and preventative actions. Assists engineers in developing methods and procedures to control or improve manufacturing processes. MAIN RESPONSIBILITIES Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Identifies and controls Manufacturing process defects (scrap,...

This is not a remote opportunity Must be able to travel up to10 % Our location in Princeton, NJ, currently has an opportunity for a Senior Customs & Trade Compliance Analyst. You will provide subject matter expertise and project leadership for site import/export matters, ensuring compliance with all relevant customs regulations and trade laws and regulations, including 19CFR,15CFR, FDA, USDA, and other US regulatory agency requirements. What You’ll Work On Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Act as subject matter expert regarding compliant import/export of goods and participate in and/or lead site/division projects related to...

This is what you will do The Patient Experience Team (PEX) team 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...

Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations Gaithersburg, MD Boston, MA South San Francisco, CA Santa Monica, CA Introduction to role Are you ready to set the global regulatory direction for first-in-class cell therapies and turn science into approved medicines? Do you see yourself steering complex programs to competitive labels and rapid, global patient access? This role leads the strategy for our most visible and complex cell therapy programs, translating breakthrough science into timely approvals and meaningful labels that unlock lifecycle value. You will work across discovery through commercialization, bringing clarity and pace to decision-making and ensuring...

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...

Associate Quality Control Must be available to work 2nd Shift - Wednesday to Saturday, 2PM to Midnight Job Responsibilities Responsible for performing laboratory testing. Assist with/ complete routine tests on products and materials and help generate laboratory results, under supervision. Maintain lab from housekeeping and stocking perspective. Perform appropriate tasks in the laboratory (e.g. sample prep, recording of results) to meet needs and demands of the work plan. Set up and take down testing and other laboratory equipment and clean up the testing sites. Identify and highlight equipment and testing issues. Support with the availability of proper equipment and supplies...

As a Senior Regulatory Affairs Director you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. R&D Oncology drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them. What you'll do As the Senior Regulatory Affairs Director you will be accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity. You will ensure that the strategy is designed to deliver rapid approval with advantageous labeling in keeping with...

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

Job Title Quality Systems Specialist We currently have an opening for a Quality Systems Specialist for the Vascular division. This role is located at our St. Paul, MN location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. MAIN RESPONSIBILITIES The Quality Systems Specialist will directly support tasks around current integration projects. Will analyze quality standards for components, materials or services. Applies measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met. Apply quality principles, analyzes quality records, prepares reports and recommends improvements....

Job Title Supervisor, Quality Systems 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...

This position works out of our New Brighton, MN location in the SH Division. Structural Heart Business Mission Why We Exist Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. What You'll Work On Lead and manage a team of 6 Supplier Quality professionals, providing coaching, development, performance management, and strategic direction. Oversee supplier quality assurance activities across a global supplier network, including supplier selection , qualification, audits, performance monitoring, and continuous improvement initiatives. Conduct and coordinate supplier audits, both domestic and international, ensuring...

As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these 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. MAIN RESPONSIBILITIES Strategic Planning Assist in SOP development and review. Provide regulatory input to product...

We are seeking a highly motivated and strategic Patient Safety Medical Review Physician (MD) to provide medical leadership and oversight of individual case safety report review activities across marketed and investigational products. This role is critical to delivering timely, high-quality medical safety assessments that support patient safety, informed benefit-risk evaluation, and regulatory compliance. The Director will serve as a recognized expert in medical safety assessment and play a key leadership role in advancing the quality, consistency, and effectiveness of Medical Review activities. This includes overseeing peer retrospective medical review quality control (MRQC) activities, supporting audits and inspections, and driving the...

The Associate Director (AD) Quality Assurance (QA for QC) is an advanced technical resource in the principles and application of quality assurance and compliance. This role is responsible for the quality oversight of Quality Control and analytical development activities of Cell & Gene programs. Activities in scope of this role include release analytical testing, stability testing, and QA support for deviations and out of specification investigations. The role will have QA oversight of technical analytical method validations and analytical transfer activities internally /CDMOs through the program life cycle management. Key Duties and Responsibilities Analytical Lifecycle Management Serve as a Quality...

The GMP Operational Quality Senior Specialist is recognized as a subject matter expert in 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. The role works with a high degree of independence and coordinates GMP activities to provide QA Analytical support for commercial product stability programs and executes routine tasks and activities in support of QA Analytical function. Key Duties and Responsibilities Provides QA review of the GMP data in support of commercial product stability as required. Has a good understanding of stability...

The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical regulatory knowledge and advanced drug development expertise in Type 1 Diabetes (T1D). The incumbent will be responsible for overseeing the development and implementation of innovative global regulatory strategies for product development and commercialization of programs within the T1D portfolio. This position will manage a group of global/regional regulatory professionals with program leadership responsibilities. This role will play a major role in shaping cohesive regulatory strategy across the programs and ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy. Key Duties and Responsibilities...

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

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Associate Quality Assurance Engineer will provide support to Operations for a variety of functions such as material receipt, production, process validation, facility qualification, and test method validation to determine the acceptability of material and the process in...

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

This role will support GxP processes and assist operations in various capacities, including providing support for the following programs Inspection Readiness, Self-Inspections, Quality Management System, Real-Time Production support, Line Clearance and Oversight, and Validation/Qualification activities. This is a 2nd Shift position, requiring a long-term dedication to the shift. Hours are 230pm-1000pm Monday thru Friday. Typical Accountabilities Support specific Quality Operations processes within assigned area External Audit Readiness - support the preparation activities for internal and external inspections, including FDA, EMA, and other regulatory bodies. Support inspection readiness plans and conduct routine mock inspections to ensure preparedness. Assist in audits, inspections,...

Associate Director Regulatory Affairs, Oncology 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. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionizing the way we do R&D. We’re uniting science, technology and...

We are searching for the best talent for a Senior Product Quality Investigation Engineer . Purpose We are looking for a Senior Product Quality Investigation Engineer to join our Product Quality Vigilance organization. Are you interested in solving complex product quality challenges while working with manufacturing, quality, and regulatory teams around the world? In this role, you will lead, conduct, and support investigations of Product Quality Complaints (PQCs) for commercial and clinical products in close collaboration with manufacturing sites. You will help ensure investigations are complete, scientifically sound, and appropriately documented within the Product Quality Complaint database. You will evaluate...

We are seeking a highly skilled and forward-thinking Senior Manager Data Standards & Quality to establish and maintain data standards and ensure consistent data quality across the entire IMSC landscape. This role bridges traditional enterprise systems (e.g., ERPs) and the shared analytics/AI readiness platform (CDL), ensuring harmonized standards and quality practices across domains. A key part of our vision is that data governance becomes the most automated component in the ecosystem , with data standards and data quality embedded into automated workflows and intelligent monitoring solutions. The Senior Manager will lead this transformation by defining frameworks, driving automation, and fostering...

Job Title Software Quality Engineer, Cybersecurity Compliance This position works at our Westford, MA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. This role is fully onsite. What You’ll Work On You will support software quality and cybersecurity compliance activities for medical device products by reviewing security alerts, tracking risk mitigation activities, and maintaining required quality documentation. Working closely with Product Development, Quality, and Cybersecurity teams, you will help ensure compliance with design controls, regulatory standards, and company quality processes. MAIN RESPONSIBILITIES Support Quality Engineering deliverables...

The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible for strategic and operational Quality oversight across multiple complex programs. This role leads day-to-day quality operations, supports the execution of new initiatives, and applies sound judgment to resolve complex quality and compliance issues. The role provides Quality oversight for drug substance disposition from development through process performance qualification, ensuring decisions align with patient safety, product quality, regulatory expectations, and business continuity. This role serves as a visible Quality partner to Product Quality Leads, MSAT, Regulatory Affairs, operational stakeholders, CDMOs, and suppliers. The successful candidate...

Join Us in Shaping the Future of Animal Health Our Animal Health Division is investing $895 million in expanding our manufacturing and research & development facilities in De Soto, Kansas — the state’s largest economic development project to date. As a Sr. Specialist, Quality Control you will be part of a world-class team at our Center of Excellence in the Animal Health Corridor, contributing directly to the production of veterinary products that improve animal health and welfare globally. This role combines project leadership/coordination and quality oversight to ensure successful QC laboratory method transfers. The Quality Control Sr. Specialist will ensure...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU within our Global Regulatory Affairs organization, based remotely. Partners with the Global Regulatory Lead (GRL) on Global...

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as an Associate Director, Risk Based Quality Management Operations based remotely reporting to the Director, RBQM Operations . At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united...

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

The Manager of Quality & Compliance (Q&C) reports into the Associate Director of Q&C for AbbVie Patient Services. This role is responsible for overseeing and improving upon established compliance and quality system processes associated with patient support programs (functional areas of responsibility will include Field Reimbursement Managers (FRM) and Customer Solutions Specialists (CSS). This person should be familiar with quality management system processes (CAPA, Training, Audits, Metrics and Monitoring) as well as change management, process mapping and continuous improvement tools. This role will support the implementation of the Patient Services Q&C Roadmap. This role is also responsible to maintain a...

Abbott is seeking a highly motivated and experienced Principal Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara, CA or Temecula, CA. In this role, you will provide regulatory leadership for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease and support global regulatory strategies throughout the product lifecycle. The Principal Regulatory Affairs Specialist will manage complex regulatory activities, including on-market product support, product development projects, lifecycle management initiatives, regulatory assessments, and global submissions. This individual will serve as a key regulatory partner to cross-functional teams and contribute to strategic decision-making...

Job Title Associate Design Quality Engineer We currently have an opening for an Associate Design Quality Engineer for the Vascular division. This role is located at our Temecula, CA location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. MAIN RESPONSIBILITIES Product development core team member responsible for quality engineering deliverables including specification development, risk management, process and test method characterization and control plan development. Plans and performs assignments of a wide degree of difficulty. Analyzes, develops, and recommends quality engineering approaches required to meet design and production...

Validation Engineer – Casa Grande, AZ Nutrition Plant As the Validation Engineer, you will ensure that change control and validation activities are executed in a timely manner while following all Abbott Nutrition Policies and Standards. This position works out of our Casa Grande, Arizona 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...

General/ The Associate Director – Shift Quality Operations is an advanced technical resource in the principles and application of quality assurance and compliance. The Associate Director provides quality leadership and oversight for manufacturing operations conducted across assigned shifts for cell therapy manufacturing. This role is responsible for ensuring ongoing compliance with cGMP , aseptic processing requirements, site quality systems, and regulatory expectations while enabling safe, reliable, and efficient manufacturing. The position partners closely with Manufacturing, Quality Assurance, Quality Control, MSAT, Engineering, Validation, and Supply Chain to support batch execution, deviation management, investigations, line clearance, contamination control, and continuous improvement. The...

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

In support of the Chief Quality Officer, define and shape the Quality strategy for the Supply Chain and In-Market Quality organization. Responsible for providing leadership and direction to Quality organization in markets globally, to ensure product release and distribution are conducted pursuant to market Current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP) requirements. This responsibility covers Quality directives, guidelines, and leadership to the Global Supply Chain (GSC) network, including product complaints, serialization, product surety, warehousing and transportation. The position leads and influences a dynamic and diverse staff of Quality professionals within markets and global Quality roles, and is...

We anticipate the application window for this opening will close on - 29 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life In this role, you'll partner across Engineering,...

We anticipate the application window for this opening will close on - 1 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Across our global Neuroscience organization, we advance...