Quality & Regulatory Jobs in Pharma & Biotech

We anticipate the application window for this opening will close on - 7 Oct 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...

AbbVie’s Global Internal Audit function plays a critical role in protecting and enhancing the organization’s value through risk-based assurance and advisory services to internal stakeholders, senior management, and our Audit Committee of the Board. Internal Audit strives to be a critical function to evaluate company, industry and emerging risks, effectively partnering with the business, and consistently recruit and develop key talent. Our goals are carried-out through the talent of the audit team, while leveraging analytical and audit tools, supported by a dynamic and collaborative team culture. The scope of compliance audits may include, but is not limited to, the following...

Primarily responsible for the execution of the Clinical audit program, including scheduling, planning, reporting and resolution of Clinical audits. Ensuring alignment with RDQA policies and procedures wherever possible and contributing to the development and implementation of the Clinical QA quality system. Provision of advice and support on GCP and quality topics to business partners to ensure compliance with worldwide requirements and expectations. Responsibilities Assure quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of Clinical processes through audit and QA oversight activities. Lead and...

Primarily responsible for the execution of the Clinical audit program, including scheduling, planning, reporting and resolution of Clinical audits. Ensuring alignment with RDQA policies and procedures wherever possible and contributing to the development and implementation of the Clinical QA quality system. Provision of advice and support on GCP and quality topics to business partners to ensure compliance with worldwide requirements and expectations. Responsibilities Assure quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of Clinical processes through audit and QA oversight activities. Lead and...

Global 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 Regulatory organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to...

Senior Associate Quality Assurance What you will do Let’s do this! Let’s change the world! The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements. Duties include but are not limited to Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments...

This position is responsible for manufacturing and product Quality activities. This role is within Mfg/Ops Quality organization and is accountable for supporting day to day sustaining activities in a manufacturing environment. The position requires exceptional communication, interpersonal, and project management skills to effectively coordinate activities and deliver results. This position will have direct interaction with Manufacturing and Process Engineering groups to support manufacturing sustaining activities, continuous improvement, and manufacturing capacity expansion. The position may also have quality oversight for more than one manufacturing area. The position will be responsible to support change management activities, Nonconformances, equipment lifecycle, meeting facilitation and...

Location Seaport, Boston Reports to Senior Director, Global Regulatory Strategy About Alexion For over 30 years, Alexion has been dedicated to transforming the lives of people living with rare diseases. We lead with breakthrough science, deep disease understanding, and a dedicated commitment to patients. As part of AstraZeneca, we are uniquely positioned to accelerate innovation and reach more patients globally. Working here means being driven by purpose, acting with integrity, and fostering a culture where people feel valued, connected, and empowered. You'll join a community that puts patients first, plays to win, and supports your development at every step. Role...

Location Seaport, Boston or Gaithersburg, Maryland Reports to Senior Director, Global Regulatory Strategy About Alexion For over 30 years, Alexion has been dedicated to transforming the lives of people living with rare diseases. We lead with breakthrough science, deep disease understanding, and a dedicated commitment to patients. As part of AstraZeneca, we are uniquely positioned to accelerate innovation and reach more patients globally. Working here means being driven by purpose, acting with integrity, and fostering a culture where people feel valued, connected, and empowered. You'll join a community that puts patients first, plays to win, and supports your development at...

We are searching for the best talent for Regulatory Affairs Manager- Digital Health. 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 Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness....

We are searching for the best talent for Senior Specialist, Supplier Quality to join our Innovative Medicine External Quality/Supplier Quality team located in Raritan, NJ; New Brunswick, NJ; Malvern, PA; Horsham, PA; Athens, GA; Wilson, NC; or Gurabo, Puerto Rico. Remote work options may be considered on a case-by-case basis and if approved by the Company. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. Within the JJIM Supplier Quality group, this role is part of a...

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Senior Specialist, QA Investigations , is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness...

Purpose of Role The Quality Control Execution Support Specialist role ( 2nd shift ) is responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management including introduction of new analytical methods, act as the receiving unit for analytical transfers, SME assessment for all analytical method & equipment performance qualification, investigations, product testing and technical rationale. This work will support pipeline and commercial products by utilizing expertise in the analytical areas of separations, biochemistry, and microbiology. Activities Within Role Technical expertise to support New method introduction (Direct to QC Validations /Tech Transfer Receiving Lab Support). New technology introduction. Assessment...

Senior Director, Global GMP/GDP Audit and Predictive Compliance Intelligence What you will do The Senior Director is the single accountable leader for Amgen’s global GMP/GDP audit organization and predictive compliance intelligence capability. The role leads an integrated enterprise function combining independent audit assurance, deep Operations compliance expertise, advanced analytics, AI-enabled tools, regulatory intelligence, inspection outcomes, supplier performance, and internal quality signals. The Senior Director is accountable for the technical depth, strategic direction, execution, and effectiveness of the global audit program while building a forward-looking capability that identifies emerging compliance risks and enables earlier enterprise intervention. The role leads two...

Are you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the research, development and commercialization of our products across the portfolio! About AstraZeneca At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about...

We anticipate the application window for this opening will close on - 5 Oct 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 Grand Rapids, Michigan manufacturing site produces...

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...

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 are seeking an experienced Process and Cleaning Validation subject matter experts to provide Validation support and leadership for development of the process and cleaning validation programs, strategies to be applied to early processes entering these validation programs, and expertise in validation project management and technical document preparation as needed. Key Responsibilities Design and implement approaches for validation studies, using knowledge and input from Process Development, Analytical Development, Manufacturing, MST/ENG, and Quality partners. Lead the development and execution validation master plans and/or project plans, protocols, and reports for process validation activities. Conduct risk assessments and gap analyses of existing validation...

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

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

We anticipate the application window for this opening will close on - 9 Oct 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 Design Quality Engineer II in Released...

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Senior Quality Engineer provides quality leadership and oversight for manufacturing daily activities, ensuring products and manufacturing processes meet regulatory, quality,...

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Accountable for leading Patient Safety quality and compliance on all key PS processes through proactive, risk‑based oversight and continuous monitoring...

As an individual contributor, the function of a Senior Regulatory Affairs Specialist (International) is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. This new team member, based on-site in Santa Clara, CA, may execute tasks and play a consultative role by partnering across business functions. The individual may 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 Manage and oversee...

The Director, Regulatory Affairs provides leadership, direction and support for regulatory policy and cross-business regulatory initiatives within the company, actively influencing changing regulations and guidance affecting the company through participation on trade associations and interfaces with regulatory agencies. This person will direct activities associated with capturing domestic and international information both internal and external that impacts the quality, regulatory, and compliance areas of Abbott and keep management abreast of regulatory changes and the impact they could have on the organization. Also, this person will direct and manage cross-business regulatory activities designed to address emerging regulatory issues, incorporate strategic action, and...

The Infectious Disease Unit at AstraZeneca is constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We are utilizing our expertise in virology, microbiology and vaccines to enable novel approaches to prevent and treat infectious diseases. Within ID Regulatory Affairs, we take innovative regulatory approaches and work across our pipeline and the business to deliver medicines to patients as efficiently and effectively as possible. The Regulatory Affairs Director (RAD) is responsible for providing strategic regulatory leadership to the development, commercialization and life cycle management of...

The Global Quality Group within the Manufacturing Division is seeking an experienced Leader to provide strategic oversight and direction for a complex, enterprise-level transformation program. This project aims to transform QC testing to support our pipeline and in-line supply products. The project has significant innovation components including end-to-end analytical digitization, analytical instrumentation innovation, lab automation, standardized laboratory workflows, and a digitized QMS and lab operations system. The Quality Lead, in collaboration with the project leadership team, will oversee integrated planning, governance, and execution across a highly matrixed project, ensuring alignment to GxP requirements while incorporating novel technical and digital laboratory...

Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed in alignment 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 dedicated to delivering a compliant, reliable supply of products to customers and patients on time, every time, across the globe. We are seeking a Growth and Improvement-minded Technical Support Senior Specialist in Quality Control that can help drive our Strategic Operating Priorities. Invent | Pursue the Most Promising Internal and...

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

Associate Quality Control - Microbiology What you will do In this vital role, you will be responsible for analytical testing, sample and data management, method development, and product characterization. You will support Quality Control operations in a non-standard shift environment, helping ensure the highest standards of product quality and compliance. Perform routine and non-routine laboratory procedures, including aseptic aliquoting and analysis for both compendial and non-compendial methods. Conduct or support activities such as sample testing, standards and reagent preparation, environmental monitoring, sample management, and equipment maintenance. Ensure accurate, complete, and timely documentation of laboratory work, and participate in document...

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

Location Morrisville, North Carolina Join Novartis and play a pivotal role in shaping the future of pharmaceutical manufacturing at our growing Morrisville site. As the Validation Lead, you will drive the site’s validation strategy across process, cleaning, packaging, and ongoing verification activities, ensuring products are delivered with the highest standards of quality, compliance, and patient safety. This is a unique opportunity to build and influence validation programs from the ground up, partner with cross-functional experts, and contribute directly to successful product launches, technical transfers, and regulatory readiness in a dynamic and innovative manufacturing environment. Key Responsibilities Lead the site...

Associate Quality Control What you will do In this vital role you will provide support for QC Centralized Raw Material Testing in the Wet Chemistry Laboratory at Amgen Rhode Island. The role will be based out of Amgen Rhode Island and will work under the guidance of the hiring manager. It is an administrative shift, Monday through Friday. The Raw Material Centralized Testing team provides analytical expertise in testing raw materials to meet Amgen specifications and ensure a constant supply of raw materials for Amgen products. The laboratory employs a variety of test methodologies from basic wet chemistry identifications...

Position Essential Functions & Responsibility Includes, but is not limited to 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,...

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?...

Purpose The Office of Ethics and Compliance (OEC) Strategic Execution and Initiatives Manager helps OEC leadership understand and effectuate global OEC strategy by connecting Compliance Program Effectiveness elements, risk-based priorities, and cross-functional activity into a coherent, actionable point of view. Acting as a trusted advisor and strategic partner to OEC leadership – centered on substantive strategic and program judgment – this role stays closely connected to OEC's priorities, decisions, and emerging risks in order to identify, shape, and drive strategic projects per year that advance the OEC program. The responsibilities that support this work, including project management, stakeholder engagement, and...

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

Johnson & Johnson is recruiting for a Compliance Project Manager. The ideal candidate will be located in New Brunswick, NJ. Johnson & Johnson believes 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. Position Overview The Compliance Project Manager is responsible for...

Manager, Process & Personnel Qualification Management Expert Join Johnson & Johnson's R&D Quality Team! Are you eager to learn, collaborate, and make a positive impact? As a Manager in Process & Personnel Qualification Management, you will drive compliance and quality excellence in the pharmaceutical industry. In this role, you will lead process improvement projects and use the latest digital tools to support the transformation from traditional processes and training into a data centric content and qualification management system. What You'll Do You will lead process and training related projects, including process development, mapping, and training development/qualification and delivery. You will...

We are searching for the best talent for Specialist Quality Compliance Drug Enforcement Administration (DEA) located in Athens, GA. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Purpose Under the guidance of the Senior Specialist Quality Compliance, the Specialist Quality Compliance will provide technical support by interpreting...

Job Responsibilities Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements - supervises QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews. Participates in writing or suggesting changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products. Works closely with operating entities to ensure that...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Key Responsibilities Provide proactive calendar and priority management for assigned senior leaders, anticipating key issues, resolving conflicts, and implementing action plans...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Key Responsibilities Provide proactive calendar and priority management for assigned senior leaders, anticipating key issues, resolving conflicts, and implementing action...

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

Global Quality Compliance, Senior Manager What you will do Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities Coordinates and leads or participates in Global Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, Critical Service Providers, Suppliers, Partners, and Wholesalers to assess compliance with all applicable regulations and to identify top compliance risks. Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to...

Associate Director, Cell Therapy Trade Compliance Operations Introduction to role 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. As our network, geographic footprint, and operational complexity continue to expand, trade compliance operations are increasingly critical to ensuring that patient materials, critical manufacturing inputs, intermediates, and finished product can move compliantly, predictably, and without avoidable delay across borders. The Associate Director, Cell Therapy Trade Compliance Operations leads the operating model for import/export and Free Trade Zone (FTZ) execution across the cell therapy network. This...

Senior Director Global Regulatory, Digital Location Gaithersburg At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3...

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

Job Title Supplier Quality Engineer We currently have an opening for a Supplier Quality Engineer for the Vascular division. This role is located at our New Brighton, 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 Individual will support Third Party Manufacturing, perform GMP inspections, 5S, and execute STOP process. Support commercial launch at Third Party Manufacturer. Work with Design and Development, Manufacturing, Purchasing and IQA when qualifying and monitoring supplier performance. A thorough understanding of the ISO/QSRs and the ability to apply that...

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

We anticipate the application window for this opening will close on - 9 Oct 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 Cardiac Surgery Operating Unit develops...

We anticipate the application window for this opening will close on - 9 Oct 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 Electro Physiology Technologies business unit is...

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

Johnson & Johnson is hiring for a Sr. Design Quality Engineer – Shockwave Medica l to join our team located in Santa Clara, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the...

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 Quality Engineer I supports product development, manufacturing, and lifecycle activities by ensuring compliance with quality systems and regulatory requirements. The...

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Senior Quality Engineer provides quality leadership and oversight for manufacturing daily activities, ensuring products and manufacturing processes meet regulatory, quality,...

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

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. What You Will Achieve 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...

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

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

GENERAL POSITION SUMMARY The Global Patient Safety (GPS) Pharmacovigilance Science (PVSci) Manager leads assigned activities related to cross-functional safety data monitoring, assessment, and aggregate reporting to regulatory agencies, and support signal and risk management activities. KEY RESPONSIBILITIES Leads PVSci activities for assigned Vertex product, including coordinating review of emerging safety data and ensuring timely identification and communication of any potential safety issues Prepares aggregate safety report content, including risk management plans and responses to regulatory authority requests Conducts signal detection/tracking and other assessments/risk management activities Provides project management support for PVSci deliverables by establishing and managing timelines, content planning and...

US Regulatory Lead What you will do US Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules. The Local Regulatory Representative (Manager) is assigned to one or more Amgen products, and plans and executes the Regulatory strategies for that product(s) in their country(ies). The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen. · Assist in aligning local regulatory requirements with Amgen’s corporate standards. · Provide local input to and execute regulatory strategies. · Plan and manage local regulatory submissions in compliance with corporate standards and local...

QC for Manufacturing - Team B Associate Quality Control What you will do In this vital role you will be responsible for activities including microbiology & analytical testing, sample and data management, as well as equipment and instrumentation operation and maintenance in a highly dynamic, team environment. Perform sample collection and sample handling to support GMP operations and Environmental/Water monitoring within Manufacturing and Utility areas. Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory procedures. This includes bioburden, endotoxin, TOC, conductivity, and MMV testing along with additional daily microbiological testing. Use of testing and data...

2027 Spring Intern - Analytical Method Validation and Tech Transfer Department Summary The Analytical Method Validation and Tech Transfer team is a group of dedicated scientists, balancing technical validation expertise with cross-functional leadership, overseeing end-to-end project-based validation/transfer activities across the GNE and global Roche network. This internship position is located in South San Francisco, on-site. The Opportunity The primary goal is to support the characterization of new control lots utilized globally for analytical method development and system suitability. The intern will play a critical role in bridging clinical and commercial activities, ensuring consistent method performance across the global network. Support...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Quality Inspector I. Purpose The Quality Inspector I will perform basic inspections and sorting of incoming materials, parts/components. Provide support as needed to the Operations group. You will be responsible for Perform inspections of purchased parts according to well-defined criteria using standard visual, physical, mechanical, and/or electrical measurements Ability to perform visual inspection on...

Johnson & Johnson MedTech is currently seeking a Sr Program Lead, Regulatory Affairs to join our team located in Irvine, CA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at JOB SUMMARY Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. DUTIES AND RESPONSIBILITIES Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Quality Assurance Supervisor, 3 rd shift to be located in Gurabo, PR. Key Responsibilities Responsible of direct supervision of the QA Auditors group and coordinates the overall activities of the...

DePuy Synthes is recruiting for a Director, Technical Quality & Compliance, located in West Chester or Raritan NJ, Palm Beach Gardens or Raynham. Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you...

Technology & Digital Quality (T&DQ) is a comprehensive organization within J&J that focuses on ensuring the highest standards of quality & compliance. It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, including specialized support for Transportation Operations and Temperature Control. Additionally, it includes a Transformation Office dedicated to steering strategic imperatives and enhancing the Quality & Compliance organization's strategy through initiatives like Data Strategy, Automated Product Release, and Digitalization of Quality Management Systems. The group further comprises a Data & Digital Strategy function tasked with developing and executing a holistic...

In Primary Posting Language (Include Requirements For Education, Experience And Skills) For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. The Quality Control Associate Specialist is responsible for performing...

We are seeking a highly skilled Compliance Specialist to support site learning and training compliance programs, ensuring adherence to Quality Management System (QMS) requirements, regulatory expectations, and global standards. This role will support training compliance, instructional design, and continuous improvement initiatives to maintain an effective and inspection-ready learning environment. The ideal candidate brings experience in GxP compliance, instructional design, performance consulting, Learning Management System (LMS) activities & curriculum management. This role partners with Subject Matter Experts (SMEs), Quality, business stakeholders, and L&D colleagues to translate business and compliance needs into effective learning solutions. Responsibilities Design, develop, update, and sustain...

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. Our Quality Assurance team works closely with Manufacturing Operations to ensure our products are made safely and to the highest...

Job Title Senior Development Quality Engineer This position works out of our Plano, TX location in 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. As a Senior Design Quality Engineer , you will play a pivotal role in advancing the safety, quality, and performance of innovative Class III medical devices throughout the product lifecycle. This position leads risk management strategy across product development, post-market surveillance, supplier changes,...

The Global Trade Compliance department's primary function is to provide corporate-wide leadership and direction for the development, administration and enforcement of policies and procedures related to Abbott's global trade compliance program. The Sr. Analyst's primary responsibility is to support and manage the post-entry aspects of U.S. Customs and Border Protection matters, including protest, prior disclosures, post-summary corrections, liquidated damages/bill review, duty recovery, and customs compliance investigations. This role partners closely with internal business teams, customs brokers, and external legal advisors to identify compliance issues, assess risk, prepare corrective actions, and ensure timely and accurate submissions to government agencies. The Senior...

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. millions of people worldwide. The Sr. Quality Engineer supports quality assurance activities within a regulated manufacturing...

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...

Quality Systems and Compliance Manager with knowledge of quality systems management, supplier quality, compliance, inspection readiness, and site training, providing oversight to ensure consistently high levels of quality performance. Responsibilities Oversee and manage all aspects of regulatory, quality, and corporate audits, and track resulting action items to ensure timely completion. Ensure site complies with all applicable regulatory and current Good Manufacturing Practice (GMP) requirements. Ensure site implements and sustains all aspects of the quality systems defined in AbbVie policies and operational documents. Maintain inspection readiness through ongoing evaluation and assessment of the compliance status site and personnel. Develop and maintain...

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

We anticipate the application window for this opening will close on - 8 Oct 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 - 5 Oct 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 are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden...

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Bristol Myers Squibb es un empleador que brinda igualdad de oportunidades. Las personas que apliquen para cualquier vacante, y que estén...

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

Johnson & Johnson is currently recruiting for a Senior Analyst, Quality Systems. This position will be located in Raritan, NJ. Key Responsibilities Provide preliminary guidance and execute quality system activities, including but not limited to Document/Records Management and Data Integrity. Act as a liaison between Raritan Advanced Therapies (AT) site and AT platform/Innovative Medicine level activities. Support document lifecycle at Raritan AT. Perform Raritan AT superuser activities. Elevate identified quality systems risks to senior management. Perform tasks in a manner consistent with the safety policies, quality systems and cGxP requirements. Actively assist in audit activities, Investigations and Change Controls. Identify...

Johnson & Johnson is currently recruiting for a Manager Quality Assurance. This position can be located in New Jersey or Pennsylvania with a preference for Raritan, NJ. The Manager, Quality Assurance provides leadership and oversight for specified external manufacturers of Advanced Therapy products, ensuring consistent delivery of pharmaceutical products from the external manufacturer that meet all required safety, regulatory compliance, and product quality standards. The Manager leads people, influences stakeholders, and ensures sustained inspection readiness and regulatory compliance. This position may lead a work team as needed, located on-site as well as remote, that is responsible for delivering the...

Johnson & Johnson is currently recruiting for a Quality System Specialist! This position can be located in Milpitas, CA. The Quality System Specialist is responsible for supporting the administration, maintenance, monitoring, and continuous improvement of the Quality Management System (QMS) to ensure compliance with FDA Quality System Regulations (21 CFR Part 820/QMSR), ISO 13485, company policies, and other applicable regulatory requirements. This role supports document control, change control, training management, CAPA activities, quality system remediation projects, compliance monitoring, quality metrics reporting, Quality Management Review (QMR) activities, and audit readiness initiatives. The individual works cross-functionally with Quality, Regulatory Affairs, Manufacturing,...

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....

The Medical Director, Patient Safety & Risk Management at Relay Therapeutics will serve as the Global Medical Safety Lead (GSL) and provides strategic and medical leadership for the safety surveillance and risk management of Relay Therapeutic assigned products throughout the product lifecycle. This role is responsible for the evaluation, interpretation, and communication of safety information; signal detection and management; benefit-risk assessment; and development of risk minimization strategies to ensure patient safety and regulatory compliance. In addition, the GSL will support the medical review of individual case safety reports and safety surveillance activities as needed for assigned Relay Therapeutic products. The...

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

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for a Supplier Quality Manager to be located at a Raynham, MA; Warsaw, IN; Palm Beach Gardens, FL or West Chester, PA. The Supplier Quality Manager is accountable for establishing and monitoring robust quality assurance programs to ensure external manufacturers consistently meet DePuy Synthes quality, regulatory, and business requirements. This includes oversight of supplier quality...

The Senior Manager Regulatory Affairs US Advertising and Promotion combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations...

The Senior Manager Regulatory Affairs US Advertising and Promotion combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations...

The Senior Manager Regulatory Affairs US Advertising and Promotion combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations...

AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is committed to driving quality excellence across all stages of discovery and development for the product’s lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients. Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVie’s evolved business strategy are complex, rapid pace, and dynamic. Emphasizing and embedding quality in the execution...

AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is committed to driving quality excellence across all stages of discovery and development for the product’s lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients. Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVie’s evolved business strategy are complex, rapid pace, and dynamic. Emphasizing and embedding quality in the execution...

Purpose Manages and provides strategic direction to laboratory business units consisting of one of the following disciplines API Laboratory Operations, Finished Goods Laboratory Operations, Raw Material/In-Process Laboratory Operations, Laboratory Support Operations, Laboratory Continuous Improvement/Compliance Operations and Microbial Environmental Controls. Responsibilities Manage a large team of lab supervisors and analysts. Is responsible to hire, lead and develop team members to ensure that the department has the appropriate talent and level of performance to meet business objectives. Assure training and development of subordinates. Assist subordinates in problem solving. Identify and resolve personnel issues without direct supervision. Assure conformance to all government and...

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

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

We anticipate the application window for this opening will close on - 5 Oct 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 - 3 Oct 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 Acute Care & Monitoring (ACM) Regulatory...

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

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

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

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

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. In this role, you will Provide strategic and operational regulatory leadership to the development, commercialization and life cycle management of the assigned products in product teams. Apply knowledge of current local and global Regulatory trends to identify future regulatory requirements and strategies. Influence Regulatory authorities...

This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. As Principal Quality Engineer, Tracking and Trending you will be the liaison for cross function departments (e.g. Research and Development, Operations and etc.) with respect to investigations and/or results of investigations related to Complaints Tracking and Trending. You will be responsible for developing test methods to identify root/potential causes...

We are seeking an experienced Director of Regulatory Affairs to build and lead Element Biosciences' regulatory function and establish the regulatory strategies and capabilities required to support the company's continued expansion into regulated diagnostic markets. Reporting directly to the Chief Supply Chain Officer, this role will serve as Element's senior regulatory advisor and will be responsible for regulatory strategy across the company's in vitro diagnostic (IVD), next generation sequencing (NGS), and regulated life science instrumentation portfolio. The Director will establish and execute global regulatory strategies supporting product development, market authorization, commercial expansion, strategic diagnostic partnerships, and lifecycle management. This individual...

Depuy Synthes is recruiting an Environmental Materials and EPR Program located in Raynham, MA or Warsaw, IN or Palm Beach Gardens, FL or West Chester, PA. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) Raynham, MA (USA) - Requisition Number R-074963 St. Anthony's Road, Leeds, UK - Requisition Number R-099784 Loughbeg, Ringaskiddy - Requisition Number R-099908 Remember, whether you...

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

The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business, but mentors team members to provide individual development in addition to efficient and valuable service to project teams. Key Duties...

The Director, Corporate Quality, will provide leadership and strategic quality oversight across Sarepta’s Clinical Development and Real-World Evidence portfolio. This role serves as a key Subject Matter Expert in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance, ensuring that all clinical trial and non-clinical study activities meet FDA regulations, ICH guidelines, and applicable international standards. This role partners closely with Clinical Development, Clinical Operations, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research, ensuring end-to-end regulatory compliance, scientific integrity, and patient safety. The Opportunity to Make a Difference Provide leadership on GCP and GLP QA support and guidance to key...

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...

The Quality Control Associate III will support the management team to ensure that laboratory and Quality systems within the QC Chemistry department remain in compliance with Biogen Idec and industry cGMP standards. Additionally, the Associate III will actively support the completion of all departmental milestones associated with clinical and commercial product manufacture and testing. The Quality Control Associate III has frequent interaction with the Supervisor, Manager and Associate Director of QC Chemistry as well as peers (Associate I, II, III) with the purpose of performing release/stability testing, leading investigations, discussions pertaining to strategic initiatives, personnel development, and testing-related issues. Importantly,...

We anticipate the application window for this opening will close on - 25 Nov 2026 Position Develop and evaluate designs which meet defined medical device product requirements and that are optimized for manufacturability, reliability, and overall cost to the business. Verify the functionality of product design by developing design test methodology and specifications to ensure product designs meet applicable performance requirements. Utilize project mgmt. and lean sigma methodologies, including Define, Measure, Analyze, Improve, and Control (DMAIC) & Design for Reliability and Manufacturability (DRM), MS Project and adhere to the applicable medical device FDA requirements for design and manufacturing, including...

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

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

Available locations Gaithersburg, MD Boston, MA South San Francisco, CA Santa Monica, CA Introduction to role Are you ready to set the global regulatory vision for pioneering cell therapies and turn breakthrough science into real options for patients? This role leads high-impact programs across cancer, immune-mediated and rare diseases, guiding them from current stage through licensure with clear, competitive pathways to approval and labeling. You will shape strategy for complex, visible programs, bringing clarity, pace and rigor that accelerate access for patients. You will report to the Executive Director, Cell Therapy Regulatory Affairs and act as a franchise global regulatory...

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

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

The Sr. Manager, QA Compliance, maintains GxP quality systems processes and procedures to drive quality compliance and business efficiencies. This position will work cross functionally with quality assurance operations, quality control, manufacturing, validation, Manufacturing Science &Technology (MS&T), and external vendors to gather, analyze and interpret and report data from product manufacturing and testing as part of trending programs (e.g., Product Quality Review, Quality Event Trending, clinical manufacturing in process and release/ stability data, laboratory controls data) to address adverse trends/ gaps as part of continuous improvement. This position will be responsible for tracking, management, and completion of Product Complaints as...

Associate Director Quality Introduction to role Are you ready to take on a pivotal role in ensuring the highest standards of quality management for our external suppliers? As an Associate Director Quality, you will be responsible for overseeing quality activities that support the execution of Quality Management for suppliers across various categories, including Formulation, Fill, Finish & Packing. Your role will involve managing quality systems, conducting supplier assessments, and interacting with regulatory agencies. You'll also serve as a subject matter expert, collaborating with cross-functional teams to drive process improvements and ensure compliance with GMP and regulatory requirements. Are you prepared...

Position Overview The Director, Quality Analytical Support provides operational leadership and technical oversight to a team of analytical subject matter experts (SMEs) supporting West Point laboratory operations. This team is responsible for direct shopfloor & operational support, deviation management, change control, and standards, sample, data, and inventory management. The successful candidate will manage daily activities, foster a culture of compliance and safety, and drive continuous improvement utilizing established production systems to ensure robust, right-first-time execution and compliance with cGMP/GLP standards. Primary Responsibilities (includes, but are not limited to) People Leadership Lead, coach, and mentor a team of analytical scientists and...

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

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

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

The Senior Director, GMP Quality will build/support and maintain fit-for-purpose quality systems, provide independent quality oversight of contract development and manufacturing organizations (CDMOs), contract testing laboratories, and other strategic partners, and ensure the company’s products and processes meet applicable regulatory, GxP, and company requirements. This is a hands-on individual contributor leadership role that will partner closely with Technical Operations, Regulatory Affairs, Clinical Development, Supply Chain, external vendors, and internal company stakeholders to support programs from development through commercialization. This role will report to the Vice President, Head of Quality. Here's how you will contribute Establish and maintain a...

The Senior Director manages a team of promotional regulatory professionals in the regulatory review of U.S. promotional materials for assigned products. Summary of Responsibilities Leads a team of promotional regulatory reviewers (senior specialists, associate directors, and individual contributor directors) to provide regulatory strategy across multiple therapeutic franchises for pipeline and in-line products that competitively positions our company's products, consistent with applicable FDA regulations and company policies for US advertising and promotion. Ensures strategy is aligned with overall corporate strategy and organizational goals. The senior director will be responsible for providing a regulatory risk assessment and managing escalations with senior leaders....

The Stability Specialist will support site stability programs and be responsible for executing stability strategies and protocols for both pre-commercial and commercial stability studies. This role will facilitate stability study management, including sample receipt, sample handling, protocol creation, stability study monitoring, and all associated GMP documentation. The Stability Specialist will support cross functional teams, including our Company sites and third parties as well as domestic and international sites. The employee will maintain clear and effective verbal and written communication with internal and external customers, participate in cross-functional teams related to stability studies, and may represent stability on site initiatives and...

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

This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As a Senior Engineer, you will be providing development and sustaining support as a part of a multidisciplinary product development team, overseeing projects throughout concept to launch in all phases of Design Controls with a focus in the disposable catheter. You will be a key contributor to the design, development and testing activities for complex medical...

Position Senior Manager, Quality Control Department Name Quality Control Reports To Site Quality Head Location Malvern (primary) and Spring House (secondary), Pennsylvania 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 The Senior Manager, Quality Control (QC) is a strategic, multi-site people leader accountable for the...

We anticipate the application window for this opening will close on - 3 Oct 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 - 3 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic Neuroscience, we are redefining what's...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Bristol Myers Squibb es un empleador que brinda igualdad de oportunidades. Las personas que apliquen para cualquier vacante, y que estén...

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

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

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

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

Purpose The Transparency Compliance Analyst is responsible for monitoring and reconciliation of transactions to ensure data is accurate and compliant with Sunshine Act, AbbVie’s OPPF, policies and procedures related to reportable transfers of value. The Transparency Compliance Analyst is also responsible for the successful close-out of activities, ensuring financial, transparency and compliance accuracy of all costs and activity associated with events as required by federal and state government reporting and regulations. Responsibilities Support compliance with all US laws and company policies for interacting with Healthcare Providers (HCPs), Healthcare organizations (HCOs), and Patients as applicable. Ensure correct reporting for all Transfers...

Join the GSK Quality Science Graduate Program, Upper Merion, US, 2027 Help us get ahead of disease together. Education required Bachelor’s or Master’s degree in Biology , Microbiology, Biochemistry, Biomedical Sciences, Chemistry, Pharmaceutical science or a related field of study. Language requirement Written and spoken fluency in English. Other requirements Graduation date by August 2027. Location Upper Merion, PA Start date September 2027 Application Information *You can apply to only one GSK Graduate Program in US, so you can focus on the role that motivates you the most. Application deadline Applications are reviewed on a rolling basis, and...

Join the GSK Quality Science Graduate Program, Hamilton, US, 2027 Help us get ahead of disease together. Education required Bachelor’s or Master’s degree in Biology , Microbiology, Biochemistry, Biomedical Sciences, Chemistry, Pharmaceutical science or a related field of study. Language requirement Written and spoken fluency in English. Other requirements Graduation date by August 2027. Location Hamilton, Montana Start date September 2027 Application Information *You can apply to only one GSK Graduate Program in US, so you can focus on the role that motivates you the most. Application deadline Applications are reviewed on a rolling basis, and this role...

Join the GSK Quality Science Graduate Program, Marietta, US ,2027 Help us get ahead of disease together. Education required Bachelor’s or Master’s degree in Biology , Microbiology, Biochemistry, Biomedical Sciences, Chemistry, Pharmaceutical science or a related field of study. Language requirement Written and spoken fluency in English. Other requirements Graduation date by August 2027. Location Marietta , PA Start date September 2027 Application Information *You can apply to only one GSK Graduate Program in US, so you can focus on the role that motivates you the most. Application deadline Applications are reviewed on a rolling basis, and this...

Quality Assurance Specialist II Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases...

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...

The Associate Director, Advertising and Promotion Compliance, US will serve as the Regulatory Affairs (RA) representative for assigned products and therapeutic areas . They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness and public affairs communications. The Associate 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 materials. The Associate Director may also act as the primary liaison with FDA on ad/promo regulatory issues concerning promotional materials....

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...

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...

Our Quality Assurance 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 interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Primary Responsibilities Provide direct shop floor support (i.e. counts, material tagging, production event support, etc. Provide quality oversight of the packaging process and plant site Evaluate defect resolution and the control of...

Senior Director, Regulatory Transformation & Innovation Job Summary The Senior Director, Regulatory Transformation & Innovation is a strategic leadership role within Regulatory Operations responsible for driving the implementation of transformation initiatives across Global Regulatory Affairs (GRA). This Senior Director will define and execute a transformation and innovation strategy that modernizes GRA-related processes by enabling new ways of working through application of digitization, AI/ML, analytics, automation, and technology solutions. Working across GRA and cross-functional partners, the Senior Director will identify, prioritize, and implement opportunities to enhance organizational effectiveness and drive business value, including through innovative approaches to regulatory document development, knowledge...

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

Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors, and Executive Medical Directors. Leading Product Safety Teams (PST) and support one or more products as the PST Lead and ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products Lead and set the strategy for key pharmacovigilance documents, including but not limited...

The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality related health authority agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will lead regulatory activities to support high quality CMC sections of regulatory documentation. Responsibilities Provide regulatory CMC strategic leadership within Regulatory and on cross-functional teams to support development of innovative genomic medicines/ex-vivo and in-vivo therapies. Develop and proactively communicate regulatory CMC strategies, risks and key issues in an evolving regulatory landscape. Act as the regulatory CMC lead and department...

Senior Quality Specialist General Medicine - VIE Contract Location United States of America, Framingham Target start date 01/01/2027 iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28. PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship. PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered....

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...

Our location in Irving, TX currently has an opportunity for a Jr. Customs and Trade Compliance Analyst. This team member will provide technical and analytical support for Customs and trade compliance matters at the site/division level, ensuring compliance with all relevant customs regulations and trade laws and regulations, including 19CFR,15CFR, FDA, USDA, and other US regulatory agency requirements. Depending on the site/division, incumbents in this position may specialize solely in import or export-related activities or may be involved in both What You’ll Work On Responsible for compliance with applicable Corporate and Divisional Policies and Procedures. Applies working knowledge of import/export...

Senior Manager, Quality Engineering This position works out of our St Paul MN OR Plymouth, MN location for our Electrophysiology business. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. We are seeking a strategic and influential Senior Manager, Quality Engineering & Analytics to lead quality systems performance, quality data analytics, and continuous improvement initiatives across the organization. This leader will be responsible for transforming quality data into actionable business insights, driving compliance, and building a long-term...

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

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

The Epidemiology & Real-World Evidence (EpiRWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the Clinical Development organization and aims to unlock the power of Real-World Evidence (RWE) to help transform innovations to life-changing medicines for patients. RWE is increasingly informing regulatory decisions across development and the product lifecycle. At the same time, evolving health authority expectations, modern study designs, advanced analytics and a rapidly expanding external RWE ecosystem create both opportunity and complexity for development teams. Reporting to the Vice President of Epidemiology and Real-World Evidence (EpiRWE), the Executive Director, Regulatory RWE Strategy and...