Quality & Regulatory Jobs in Pharma & Biotech

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

About Vision 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 on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime....

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

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

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Manager, Environmental Health, Safety & Sustainability (EHSS) Environmental Compliance is responsible for leading the implementation, oversight, and continuous improvement of...

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

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. What You Will Achieve In this role, you will Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements. Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution. Conduct statistical analysis of testing results...

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

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

Associate Quality Specialist The Associate Quality Specialist is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday. What You’ll Work On Responsible for implementing and maintaining the effectiveness of the Quality System. Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation. Assist in determining quality attributes and requirements. may provide...

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

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...

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

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

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

Job Title Associate Quality Engineer (second shift - 330pm to 200am) This position works out of our Westford, MA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. This is an onsite role. Schedule is Monday - Thursday, 10-hour shifts. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents What You’ll Work On This position is responsible for...

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

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

You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. The Quality Specialist supports Quality Management System (QMS) execution and quality operations within the Woolwich Distribution Center, ensuring compliance with regulatory requirements, internal quality standards, and Medtronic quality system procedures. This role partners closely with Distribution Operations, Supply Chain, Engineering, Regulatory Affairs, and Quality leadership to support product flow, nonconforming product management, audit readiness, process improvement, and continuous quality initiatives that enable safe and compliant distribution activities. This position is based in Swedesboro, New Jersey and is fully onsite. Approximately 5% travel is required, primarily...

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

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

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

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

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

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

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

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

Johnson & Johnson is recruiting for an Experience & Compliance Senior Specialist to be located in New Brunswick, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at The Experience & Compliance Senior...

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

Johnson & Johnson is recruiting for an End-to-End (E2E) Distribution Excellence Quality & Compliance (Q&C) Lead to be located in either Coppell, Texas or Irving, Texas. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The End-to-End (E2E) Distribution Excellence Quality & Compliance (Q&C) Lead supports the identification, development and execution of end-to-end quality and compliance...

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 . Transcend is a global business transformation program that will modernize our foundational transactional processes and harmonize them into one “clean” ERP as a standardized platform for growth and efficiency gains. This program will simplify the Pharmaceutical ERP landscape...

Johnson & Johnson is currently recruiting for a Quality Control Analyst, CAR-T Critical Reagents! This position will be located in Raritan, NJ. Johnson & Johnson Innovative Medicine and Legend Biotech

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

We are searching for the best talent for a Sr. Executive Administrative Assistant. This hybrid role will be in Raritan, NJ, Horsham, PA and Titusville, NJ. The requirement for this position is to work in the office 3-4 days per week and work from home 1-2 days per week . 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...

Johnson & Johnson is recruiting for an Experience & Compliance Specialist to be located in New Brunswick, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at The Experience & Compliance Specialist supports...

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

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

Director, Global Supplier Quality – Material Quality Network Oversight The Director, Global Supplier Quality will focus on network oversight for material quality and is responsible for providing proactive, network-level Supplier Quality oversight of GMP materials across the Gilead network. The primary purpose of this role is to anticipate and prevent material quality issues by connecting information across sites, materials, suppliers, quality systems, and emerging requirements. This role will establish global visibility to material quality signals and trends, identify emerging or systemic risks, and facilitate preventive actions with suppliers and internal stakeholders to mitigate issues recurrence or expansion across the...

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

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

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

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

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

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

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

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

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

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

Quality Control Specialist Introduction to role Are you driven to ensure cell therapy products meet the highest standards and reach patients without delay? Do you see yourself using rigorous analytical science to accelerate safe, effective treatments to those who need them most? Join our Quality Control team and take on a high-visibility role where your decisions and data will directly influence product release and stability strategies. In this role, you will be a key contributor to advancing our cell therapy pipeline, owning analytical method qualification and executing critical testing that underpins lot release and in-process control. You will organize, analyze,...

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

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

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

Our Quality organization ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed in alignment with our incredibly high standards of quality while meeting all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. The Associate Director within Quality is responsible for providing quality direction and oversight to a Drug Substance capital project according to our quality systems, including Training, Documentation, Change Control, Inspection Management, Quality...

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

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

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

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

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

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

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

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer to be located in Jacksonville, FL; Irvine, CA; Danvers, MA; Raritan, NJ; or New Brunswick, NJ. Purpose This role provides strategic leadership for healthcare compliance within a highly dynamic and regulated environment while enabling compliant and sustainable growth across Johnson & Johnson Vision’ businesses. The Senior Manager, HCCO will be primarily responsible for the implementation and support of programs designed to ensure the Company meets statutory and regulatory requirements relating to health care fraud and abuse; as well as advertising and promotion laws governing the...

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 Operations Technician. Purpose Responsible for conducting technical quality assurance inspections, quality issue resolution, product containment, and supporting quality improvements for production processes and standards. You will be responsible for Supports Quality Operation functions including CAPA/NC initiatives, Quality “presence” on the manufacturing floors, and proactive GDP and Data Integrity. Assist with data collection for...

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

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

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

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

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 Manager, EHSS and DEA Regulatory provides strategic and operational leadership for Environmental Health, Safety & Sustainability (EHSS), emergency preparedness,...

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

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

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

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

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

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

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

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

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

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives. Main Responsibilities Promoting a culture of excellence and ensuring full implementation and sustainability of SMS 2.0...

Quality Control Microbiology Specialist Job Purpose The QC Specialist supports Quality Control laboratory operations by providing technical, documentation, investigation, and project support to ensure compliant, efficient, and reliable laboratory performance. This role writes, updates, and reviews laboratory procedures and technical documents; leads quality investigations and corrective/preventive actions; supports Quality Operations and GMP performance initiatives; drives continuous improvement and problem-solving activities; and represents the QC team on site-based projects, shutdowns, maintenance activities, and other non-routine work. Key Responsibilities Writes, updates, reviews, and maintains Laboratory Standard Operating Procedures, Analytical Methods, Specifications, and related controlled documents in alignment with current Good Manufacturing Practice...

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

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

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

Build our future together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director to join our Patient Safety team. The Global Patient Safety (GPS) Lead role (Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s)/asset(s) assigned within a given therapeutic area (TA), and is the GPS representative on the cross functional strategic program team (SPT) for the compound. The GPS Lead leads the safety strategy and ensures the optimal support from within GPS and works collaboratively with stakeholders...

The team vision is to become catalysts for providing risk based, predictive & objective assurance, insight, support, intelligence & The team vision is to become catalysts for positive change by identifying the unseen, providing risk based, predictive & objective assurance, insight, support, intelligence & advocacy. The mission is to foster best in class performance by leveraging data, technology, and diverse talents to secure product launches and support compliance through quality audits, regulatory inspections, regulatory surveillance and advocacy. Core values are integrity, collaboration, innovation and expertise. The team is comprised of ~40 people in 7 countries in USA, Euro Scope Includes...

The Associate Director, CMC Regulatory Affairs – Combination Products and Device is responsible for defining and advancing global CMC regulatory strategy for products, platforms, or major workstreams involving devices and combination products. This role ensures that regulatory strategy is integrated into development and lifecycle planning and that submissions are executed in a manner that supports approvability, business objectives, and continuity of supply. The Associate Director acts as a strategic partner across Pharmaceutical Development & Manufacturing (PDM) and cross-functional teams by translating complex technical, development, and regulatory considerations into clear regulatory pathways, risk-based recommendations, and executable plans. KEY RESPONSIBILITIES Define and...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer , to be based in Danvers, MA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Purpose The Senior Manager, Health Care Compliance Officer will be responsible for collaborating with Cardiovascular business partners and providing strategic guidance on activities and processes that have health care compliance-related implications. The Health Care Compliance Officer will provide direction and...

We are searching for the best talent for a Director, Regulatory Affairs to join our Orthopaedics team located in Palm Beach Gardens, FL, West Chester, PA, Warsaw, IN or Raynham, MA. Purpose The Director, Regulatory Affairs is responsible for setting regulatory strategy, and in partnership with cross-functional teams, driving excellence in product innovation, launch and portfolio management. This position is also responsible for providing direction and leadership to the Regulatory Staff in the development and implementation of global regulatory strategies and processes to assure timely commercialization of products in key markets in compliance with current and appropriate worldwide regulatory expectations....

We are currently seeking a highly qualified individual to join our team as a Quality Systems Specialist at our new Biotherapeutics Manufacturing facility in Wilson, North Carolina (BioNC). 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 Essential Job Duties and Responsibilities This position is responsible for leading and/or supporting Quality...

Johnson & Johnson Health Care

Johnson & Johnson is currently seeking a Manager, Quality Clinical Risk Management to join our R&D Quality CRM team located at a J&J office in Spring House, PA; Titusville, NJ; Raritan, NJ; Horsham, PA High Wycombe, UK Beerse, Belgium; Basel, Switzerland, and Madrid, Spain. 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...

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....

DePuy Synthes is recruiting for a Technology Mgr, Quality Systems, Analyst , located in Raynham, MA or West Chester, PA or New Brunswick, NJ or Palm Beach Gardens, FL or Warsaw, IN. The Technology Manager, Quality Systems, Analyst leads the technology capability supporting DePuy Synthes enterprise quality systems within the Supply Chain Technology function, Quality sub-function. This role manages a team of individual contributors and/or supervisors and is accountable for effective performance management, capability building, and career development. The Manager develops tactical and operational plans for the quality systems portfolio, owns and executes the product roadmap across complaint handling, CAPA,...

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 Global Regulatory Affairs Scholar, located in Spring House, PA, Raritan or Titusville, NJ. This role is eligible for one-way US relocation assistance. Global Regulatory Affairs Scholar Program Overview The Global...

We are searching for the best talent for Manager, Data Quality About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Purpose The Manager, Data Quality is accountable for improving the integrity of data across the One Data Platform (ODP). The role leads data quality operations, business-rule validation, data...

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 Global Regulatory Affairs Scholar, located in Spring House, PA, Raritan or Titusville, NJ. This role is eligible for one-way US relocation assistance. Global Regulatory Affairs Scholar Program Overview The Global...

DePuy Synthes is recruiting for a Sr. Director, Regulatory Law, Orthopedics located in Raynham, MA, New Brunswick, New Jersey, West Chester, Pennsylvania. 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 sometime in 2027, 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...

We anticipate the application window for this opening will close on - 30 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 Medtronic, a global leader in medical technology,...

Business Introduction GSK remains committed to achieving bold commercial ambitions for the future. By 2031, we aim to deliver £40 billion in annual sales, leveraging our existing strong performance momentum to significantly increase our positive impact on the health of billions of patients globally. Our Ahead Together strategy is centred on early intervention to prevent and alter the course of disease, thereby protecting people and supporting healthcare systems. Our diverse portfolio consists of vaccines, specialty medicines, and general medicines. Through continuous innovation and a dedicated focus on scientific and technical excellence, we strive to develop and launch new, groundbreaking treatments...

The Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages the interactions with Health Authorities for CMC topics. This role also provides regulatory guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial products. This role may supervise other regulatory staff. Key Duties and Responsibilities Leads the preparation and review of CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies Develops global CMC...

Are you ready to shape how we communicate life-changing science to patients and healthcare professionals—safely, compliantly, and with impact? This role supports the US advertising and promotional compliance strategy for assigned products, ensuring our external communications are scientifically rigorous, fair-balanced, and fully aligned with FDA requirements. You will partner closely with cross-functional colleagues in medical, legal, regulatory, commercial, and regulatory operations to drive high-quality promotional and scientific materials from concept to submission. Can you anticipate regulatory risk and translate complex guidance into clear, actionable direction for teams? Your work will enable timely launches, confident market presence, and consistent, ethical engagement...

Reports to Regulatory Operations (RegOps) Director in OPAR. The RegOps Associate Director is responsible for the review, approval, and oversight of regulatory submissions to the promotional review divisions of FDA (OPDP/APLB) for all U.S. products. Ensures regulatory submissions are aligned with FDA regulations and our Company standards. Functions as a point of contact for operational activities and coordinates with other Regulatory Affairs teams, including Publishing, Information Management, Data Sciences, and Regulatory Affairs Functions. Develops analytics, reports, and dashboards; leverages predictive modeling to identify trends and insights; and prepares quarterly metrics to track operational performance. Provides direction and performance management for...

Build our future together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Manager to join our Regulatory Affairs Advertising and Promotion team. The Associate Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). Provides regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs,...

Build our future together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager to join our Regulatory Affairs Advertising and Promotion team. This position requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). They will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs, Advertising and Promotion Director....

Build our future together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Regulatory Affairs Advertising and Promotion team. In this role, you will apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). This individual will provides regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs, Advertising and Promotion Director. The Manager...

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

Envision spending 6 months working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie AbbVie Co-Ops. The Quality Assurance Validation department is responsible for plant validation including validated system (Equipment/Process), risk/design and change control compliance. Our team ensures alignment with Global Quality Systems for validation and related functions, e.g. engineering, risk management. Key responsibilities include The Validation Engineering Co-Op will support the planning and execution of tasks reporting into the QA Validation department. This role will support various areas of manufacturing...

Envision spending 6 months working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie AbbVie Co-Ops. The Quality Assurance Validation department is responsible for plant validation including validated system (Equipment/Process), risk/design and change control compliance. Our team ensures alignment with Global Quality Systems for validation and related functions, e.g. engineering, risk management. Key responsibilities include The Validation Engineering Co-Op will support the planning and execution of tasks reporting into the QA Validation department. This role will support various areas of manufacturing...

Director, Contract Testing Laboratories Quality Oversight The Director, Contract Testing Laboratories (CTL) Quality Oversight is a critical leadership role within our external Quality organization. The incumbent is accountable implementing Divisional and Company policies, procedures, and guidelines, and for Quality Assurance responsibilities for our company’s contracted testing services globally. This role ensures that all product modalities (drug substance, drug product, finished product) tested at CTLs are analyzed and that cell banking manufacture and storage is in accordance with Company standards and all applicable regulatory requirements, meeting both internal and external customer demands and protecting patient safety. Primary responsibilities Leads the strategy,...

We are searching for the best talent for a Sr. Quality Engineer , located in Danvers, MA or Woburn, MA. A pre-identified candidate for consideration has been identified. However, all applications will be considered. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Purpose In this role, you will have the unique opportunity to contribute to the manufacturing of life-saving medical devices. As part of our "Patients First!" culture, you will...

This role will support the Design Quality Engineering Group under DePuy Synthes for the Trauma, Extremities, Craniomaxillofacial (CMF), and Animal Health businesses with the objective of launching and sustaining orthopaedic implants and associated instrumentation. This position contributes directly to product development, innovation, and lifecycle support by applying technical knowledge to ensure product performance, safety, and regulatory compliance. The role offers the opportunity to influence next‑generation solutions that improve patient outcomes while collaborating across R&D, Quality, Regulatory, and Manufacturing teams. You will be responsible for Product development and life cycle management activities related to the Trauma and CMF business. Leading product...

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 Manager, ICSR Compliance to be located in Horsham, PA; Raritan, NJ or Titusville, NJ. Purpose The Manager, ICSR Compliance is responsible for leading Pharmacovigilance (PV) compliance oversight activities related to...

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 Complaint Quality Approver to be located in Gurabo, PR. The Complaint Quality Approver is accountable for independent, objective review and approval of complaint records to ensure investigations are complete, scientifically...

At Abbott Cancer Diagnostics, we are cancer fighters. We are united by our mission to change lives by providing earlier, smarter answers. Through advances in cancer detection and treatment guidance, we will help eradicate the disease and the suffering it causes. This Engineer I, Quality role will be involved in all phases of system development including requirements, analysis, design, testing, and support. The ideal candidate must demonstrate the ability to understand system architecture, design, implementation and possess the ability to succinctly develop the testing strategy to deliver high-quality results in a time-sensitive environment. Location Onsite in San Diego, CA or...

This Associate Director, Regulatory Affairs will work on-site at our Westford, MA location in the Vascular Division. As a manager, the function of an Associate Director, Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual will develop and supervise regulatory professionals. The individual has department level influence and is generally recognized as an expert resource both within Abbott and externally. The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management...

This Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re 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. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment. In this role, you will combine knowledge of scientific, regulatory, and business issues to enable products...

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 Director, Compliance Policy & Education is a member of the Compliance & Ethics Leadership Team responsible for three enterprise...

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 Site Director, Development Quality is a senior leadership role with a significant opportunity to influence how Quality enables the delivery of our exciting development portfolio. At its heart, the role is about protecting patients, ensuring GMP standards are met at the site while creating an environment in which quality enables development teams to move with pace, confidence and appropriate risk management. The Site Director provides Quality leadership at the site and contributes to the strategic direction of Development Quality globally. As a Quality leader, the role partners with leaders across Development and Supply Chain globally, helping teams build quality...

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

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a QC Specialist III at Gilead, you will support Quality Control laboratory operations through the administration, enhancement, integration, and continuous improvement...

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...

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 Manager Regulatory Sciences Innovative Medicines is accountable for the local regulatory oversight of the assigned BMS products in...

The Senior Associate, Regulatory Affairs Submission Management , manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as very knowledgeable in their discipline expert and in regulatory affairs submission management. Responsibilities Manages medium to high impact (with respect to internal visibility,...

The Manager Regulatory Affairs, Global Regulatory Strategy US & Canada is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual assists Regulatory Staff by identifying and gathering data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. Responsibilities Responsible for a product(s) within a Therapeutic Area and supports the Manager (Senior Manager, Associate Director, Director (Global Regulatory Lead (GRL), in the...

The Senior Associate, Regulatory Affairs Submission Management , manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as very knowledgeable in their discipline expert and in regulatory affairs submission management. Responsibilities Manages medium to high impact (with respect to internal visibility,...

POSITION SUMMARY The CQV Engineeris responsible for the service and support of laboratory equipment and instrumentation utilized in the Operations laboratory. The scope of support includes installation, calibration, maintenance, and repair of both simple (e.g., plate sealers) and complex (e.g., liquid handling robotics) instrumentation in the laboratory. The Instrument Service Engineer will be the primary point of contact for production lab personnel when equipment and instruments are not operating or not meeting operational specifications. PRIMARY RESPONSIBILITIES Provides Level 2 support for all laboratory equipment, troubleshooting hardware and software with some support from Level 3, Automation, and vendor. ...

About This Role The Sr. Manager, Global Regulatory Affairs (GRA) supports the regulatory strategy and execution for assigned programs, working closely with the Global Regulatory Lead (GRL) and cross-functional teams. This role contributes to the development and implementation of regulatory submissions across multiple regions, ensuring alignment with global regulatory requirements and timelines. The Manager also serves as a key point of contact for regulatory operations and external partners (e.g., CROs), and provides backup support for regulatory activities within the team. What You'll Do Collaborate with the Global Regulatory Lead to support regulatory strategy and execution for assigned programs. Participate in...

The Supplier Quality Engineering Co-op supports the Supplier Quality team in maintaining and improving the quality of materials, components, and services provided by external suppliers. Working under the guidance of experienced Supplier Quality Engineers, the co-op will contribute to supplier performance monitoring, quality data analysis, documentation, investigations, qualification activities, and continuous improvement projects in a regulated medical device environment. This position provides practical experience applying engineering, quality, and problem-solving principles while working with cross-functional teams and suppliers. The co-op is expected to follow company procedures, protect confidential information, and support environmental, health, and safety objectives. ESSENTIAL FUNCTIONS / RESPONSIBILITIES Support...

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

The Senior Quality Engineer provides technical quality leadership for computerized systems, equipment, and digital solutions used within a regulated environment. This role is responsible for developing and executing Computerized System Validation (CSV) strategies, applying risk-based approaches to qualification and validation, providing quality guidance with change management, and ensuring systems and processes maintain appropriate data integrity throughout their lifecycle. The Senior Quality Systems Engineer partners with Quality, Manufacturing, Engineering, IT, Automation, system owners, and business process owners to ensure that systems are fit for intended use, appropriately controlled, and maintained in a validated state. The position serves as a subject matter...

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities Identifies product-specific or therapeutic area A&P issues and works with other teams to...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Manager, Quality Engineering, Change Control/Document Review at the Summit Cell Therapy Manufacturing facility is responsible for supporting the business...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Summary This position is critical to maintaining quality oversight and ensuring GMP compliance in day-to-day manufacturing operations. The Senior Field QA...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Sr. QA Specialist, you will hold a key role accountable for delivering Quality Assurance objectives supporting the Foster City Manufacturing...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As the Sr. Manager, Quality Assurance, you will hold a key role accountable for strategizing and delivering Quality Assurance objectives supporting the...

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US. In this role, you will provide regulatory input...

Job Title Assoc. Quality Engineer We are seeking an Associate Quality Engineer to work at our Temecula, CA location in our Vascular division. The Associate Quality Engineer provides process/quality engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provides process/quality engineering support to product development teams, helping to ensure development of highest quality new products. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents....

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

This role provides quality oversight of the Batch Release Protocol (BRP) process and final release to market. This role will perform final review and approval of all batch release protocols for both foreign and domestic submissions. Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. Benefits of working in this role Be part of an inspiring mission to create life-saving vaccines Leading a skilled and motivated team of quality professionals The work environment is a highly collaborative and technical...

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business...

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

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

Serves as primary Quality Assurance associate supporting the day to day manufacturing operations in the Jacksonville IOL manufacturing site. The individual performing this role will have to create a strong network base with the line supervisor(s), technicians and engineers to address all the opportunities found in the assigned manufacturing line or quality system process Overall responsibilities include planning, conducting and directing engineering projects or studies requiring general technical knowledge. Applies basic engineering principles and practices within assigned areas. Utilizes basic Quality Engineering tools and practices to support the effective and efficient development, transfer and maintenance of products/processes throughout the product...

Johnson & Johnson is currently recruiting for a Staff Quality Engineer. This position will be located in Irving, TX. JOB SUMMARY The Staff Quality Engineer serves as a senior technical leader within Quality Operations, providing strategic direction and subject matter expertise across Quality Systems, Nonconformance Management, CAPA, Process Validation, Risk Management, and Continuous Improvement. This role leads complex cross-functional quality initiatives, drives systemic process improvements, ensures regulatory compliance, and mentors quality professionals while influencing stakeholders across Operations, Engineering, Supply Chain, Manufacturing, and Regulatory functions. The Staff Quality Engineer is expected to lead high-impact quality investigations, identify and address systemic issues,...

This position is based on our Abbott Park, IL location in the OEC (Office of Ethics and Compliance). This is an onsite position. As Sr. Compliance Specialist , you’ll have the chance to work in the Abbott’s Compliance Training team that is responsible for Abbott’s worldwide compliance training strategies, including managing its compliance learning training system (LERN). This position will work under supervision of, and report directly to, the Compliance Training Manager, interacting with Abbott personnel around the world at all levels. What You’ll Work On Support Abbott’s Office of Ethics and Compliance (OEC) compliance training strategy and global implementation....

This position supports Operations within the Cancer Diagnostics business. As a Quality Assurance Engineer, you will partner with Facilities, Service & Metrology, Process and Controls Engineering, Instrument Production, Reagent Manufacturing, Quality Control, and other areas of Operations. Depending on the assigned area, you will provide Quality oversight of products, materials, manufacturing and QC laboratory equipment and processes, instrumentation, facilities, utilities, and associated systems through qualification and validation, risk management, investigations, change control, and continuous improvement. What You'll Work On Provide Quality Engineering oversight of manufacturing processes, instruments, equipment, facilities, utilities, and automated systems throughout their lifecycle, including qualification, validation, maintenance,...

Gilead Sciences is seeking an experienced validation leader to head the Manufacturing Validation function at the Foster City site. This role will establish and lead an integrated, risk-based validation program for the facilities, utilities, equipment, automation, and computerized systems supporting a new state-of-the-art biologics facility. In partnership with Engineering, Manufacturing, Quality, Automation, IT, and project teams, this leader will define the validation framework, build the capabilities required for execution, and ensure the new facility is compliant and inspection-ready from startup through routine operations. The successful candidate will also lead and integrate the existing validation team supporting the site’s small-molecule clinical...

We anticipate the application window for this opening will close on - 31 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...

Quality Compliance Senior Manager What you will do Let’s do this! Let’s change the world! The Senior Manager leads the Quality Intelligence Center (QuIC) integrated quality oversight operating model and the governed signal-to-action lifecycle through which QuIC-generated signals, trends, dashboard outputs, and emerging quality insights are reviewed, contextualized, triaged, routed, monitored, and closed. The role leads the QuIC team and establishes business standards, review routines, governance inputs, decision pathways, and cross-functional ways of working required to embed QuIC into R&D Quality oversight. Key responsibilities Lead the day-to-day operation of the QuIC function and manage a professional team responsible for portfolio-level...

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

Reports to Head, Regulatory Data Vanguard (RDV) and accountable for the oversight & execution of global data management activities spanning multiple regions, products etc. in support of new and remediation activities. Also accountable for the overall integrity and quality of Pfizer Global regulatory data through the oversight of data quality, completeness and timeliness, working in close partnership with the relevant BPO’s to inform procedural and process updates. Accountable for measuring, experimenting and driving GRS towards data excellence through innovation and improvement, utilizing existing and new capabilities such as AI, data science, automations and reports in support of optimizing data quality...

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying , and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our fervor for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. The Specialist, Quality ensures compliance with quality system's procedures and assessing...

We anticipate the application window for this opening will close on - 31 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 Neurovascular business within Medtronic develops technologies...

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

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

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

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...

POSITION SUMMARY The Sr. Regulatory Affairs Specialist is responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business. PRIMARY RESPONSIBILITIES Understands and interprets U.S. and EU and international medical device and in vitro diagnostic device (IVD) regulatory requirements. Provides guidance on requirements to product development teams. Develops strategies...

Located at our global headquarters in Foster City, CA or Parsippany, NJ, as a Director, Ethics & Compliance Investigations , at Gilead you will... The Director, Ethics & Compliance Investigations, plays a key role in promoting Gilead's culture of integrity, transparency, and accountability. We are seeking a dedicated and experienced investigator to join Gilead's Ethics & Compliance Investigations team. This position will lead and manage internal investigations into potential violations of law, regulation, or company policy, ensuring that each investigation is handled promptly, confidentially, and in accordance with company policies and regulatory requirements. The successful candidate will bring high emotional...

Engineer - Process Development (Commissioning, Qualification, and Validation) What you will do In this role, you will support the commissioning, qualification, and validation (CQV) of GMP equipment and processes that enable Final Drug Product (FDP) operations at the Amgen Ohio (AOH) site. You will apply strong engineering and scientific principles to ensure new and existing systems meet Amgen and regulatory requirements throughout the validation lifecycle. As a key contributor to AOH’s growth, you will play an essential role in technical transfer, equipment startup, process validation, and continuous improvement across automated device assembly, packaging, and FDP manufacturing operations. Your work...

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

Innovation doesn't happen by doing more of what we've always done. This role is for a regulatory professional who is ready to challenge assumptions, question what we've stopped questioning, and help us accelerate how we bring medicines to patients. You will be part of building something new - a function that transforms how Sanofi conceives, builds, and delivers regulatory submission and obtains authorizations – our mission is to create awareness, clarity and capabilities that enable teams to make better choices to accelerate regulatory authorizations. What makes this role unique You will help build a brand-new function from the ground up....

We anticipate the application window for this opening will close on - 31 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...

As a Co-op in the MedTech (MT) Quality Engineering organization, you will have the chance to Collaborate with teams across J&J MedTech on Quality Engineering projects. Support and/or perform risk management activities. Learn and apply various statistical techniques to analyze data. Develop and contribute to training materials including procedures and work instructions. Strengthen presentation, communication, and leadership skills. Work with a diverse team of quality, development, test, and design engineers. Take advantage of training courses offered at J&J. Support project teams in ensuring the product being developed is safe and effective for patient use. The Quality Engineer Co-op will Have...

As a Co-op in the MD Quality and Compliance (Q&C) Digital Solutions organization, you will have the chance to Use state of the art tools and take advantage of training courses offered at J&J. Collaborate with teams internal and external to the advanced analytics to implement customer-centric solutions for data analytics and process improvements Perform software development and validation to support medical device quality system digital solutions. Learn and apply various software development and lifecycle management techniques. Promote digital culture and capabilities across J&J medical devices Strengthen communication and leadership skills. Work with a diverse team of data scientists, analytics...

General position summary Biomarker Operational Quality Associate director provides Biomarker quality leadership and oversight across GxPs-related to research and development, implementation into clinical trials and potential commercialization of clinical biomarkers into IVDs. The incumbent will collaborate with business partners and GCP Operational Quality to drive quality outcomes and operational excellence, through supporting operational management oversight for these areas. The Associate Director will ensure that quality oversight activities maximize value, impact and delivery in assuring compliance, excellence in quality and readiness for future needs. The Associate director, Biomarkers Operational Quality will also collaborate with the Biomarker Operations team to review and...

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

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

Join GSK’s Quality Control Laboratory Associate Apprentice Program – US, 2027 Help us get ahead of disease together GSK Apprenticeships are full-time entry level opportunities that offer high school graduates and community college students the opportunity to begin their career while studying towards their associate degree. This associate degree is fully funded by GSK, which means NO COLLEGE DEBT! Education required High School diploma or equivalency diploma by June 2027. High school GPA 2.5 (“B”) or above (4.0 scale) High school Algebra and Geometry or 2 units equivalent of academic math (GPA 2.5 or above in each case) High school...

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

The Manager Quality Systems 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 responsibility may include supplier qualification and approval, supplier risk management, , supplier change management, , and Approved Supplier List (ASL) governance. 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...

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...

In this key role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities. Key responsibilities include Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans Conduct the formal review and approval of authored documents, following applicable standard operating procedures With limited supervision,...

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

We aspire to be the premier research-intensive biopharmaceutical company. At Join us in our mission to promote transparency, accountability, and ethical use of data and AI. The Associate Director, Governance Risk and Compliance for Data, Data Products and Digital Solutions will lead the development and implementation of governance, compliance, privacy, and responsible AI practices across data, data products, and digital solutions. This role partners with cross-functional teams to embed practical controls and standards throughout the data and AI lifecycle, ensuring solutions are developed and used in alignment with company policies, enterprise standards, and applicable regulations. The position supports the...

We anticipate the application window for this opening will close on - 30 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 Bring your talents to an industry leader...

This position works out of our Lake Forest, IL location in the Core Lab , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Regulatory Affairs Manager provide regulatory review and strategic guidance for advertising and promotional materials and activities, including digital, customer-facing, and external communications supporting U.S. and global marketing initiatives across medical devices, in vitro diagnostics (IVDs), Digital Health solutions, automation platforms, software-enabled...

That’s what makes us Genentech / Roche! In Pharma Development Quality (PDQ), we strive for confidence in the integrity of our data and processes, agility, and unrivaled transparency with health authorities, patients, and society. Our work provides leadership, know-how, and partnering on quality across Molecules (GCP), Products (Drug and/or Medical Devices), Pharma affiliates, and global regulated processes. This role supports the Roche/Genentech Organization by developing and delivering Quality Assurance strategies, audits, and conclusions for post approval products, affiliates and processes, based on a risk-based approach. Quality Assurance strategies are based on the Critical to Quality framework, encompassing Good Clinical Practice...

As a trusted validation engineer, you will influence projects from concept through operational release, partner across Manufacturing, Laboratory, Facilities, Quality, Engineering, MS&T, and IT, and help build a culture in which quality, innovation, and compliance strengthen one another. Typical Accountabilities Lead/coordinate validation strategies and lifecycle deliverables that translate risk, regulatory expectations, and business needs into clear plans, robust testing, traceability, and defensible conclusions. Guide the qualification and continued control of GMP facilities, utilities, equipment, temperature-controlled storage units, manufacturing systems, and laboratory equipment that support dependable operations. Direct protocol planning and execution, evaluate installations and changes, and integrate...

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

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

Director, Security and Compliance Job Overview The Director of Security and Compliance is a strategic, highly technical leader responsible for designing, scaling, and overseeing our global information security and regulatory compliance programs. Reporting to the CIO, this role bridges the gap between technical security engineering, legal requirements, and business operations. Key responsibilities include defining our security posture, leading Governance, Risk, and Compliance (GRC) initiatives, and ensuring continuous alignment with industry frameworks. The ideal candidate for this role is someone who doesn't just manage checklists but actively translates complex regulatory policies into practical, testable technical controls that allow our engineering and...

Location Kendal Square, Boston Hybrid 3 days a week on site Medical Director, Senior Safety Physician We are seeking an experienced physician to provide medical leadership for clinical safety and benefit-risk management across the lifecycle of assigned products and development programs. This role is accountable for shaping and executing safety strategy, evaluating emerging safety data, and ensuring the effective communication of safety information to internal and external stakeholders. Working within a global, cross-functional environment, you will collaborate with experts across Clinical Development, Regulatory Affairs, Epidemiology, Safety Science, Risk Management, and Medical Affairs to protect patient safety and support the successful...

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

Specialist, Global Analytical Instrument Validation Specialist, Pharmaceutical Analysis & Digital Technologies The Pharmaceutical Analysis & Digital Technologies (PADT) Analytical Capabilities and Operations (ACO) department of our Research & Development Division is seeking applicants for a Validation Specialist position available at the West Point research facility. The Analytical Instrument Validation Specialist will work as part of the integrated Validation and Compliance team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The Analytical Instrument Validation Specialist role oversees and/or supports the validation of novel computerized analytical instrumentation within the GMP...

About This Role As a Senior Associate II in Quality Audits, you will play a pivotal role within the Corporate Quality team, focusing primarily on audits in the Regional Americas. You will independently conduct risk-based audits to ensure compliance with regulatory requirements, international standards, and company quality expectations, primarily under ISO 13485 and applicable GxP regulatory frameworks including FDA and EMA guidelines. Your role will enhance our audit program by supporting inspection readiness and supplier qualification, while contributing to the continuous improvement of our Quality Management System (QMS). With a degree of autonomy and professional judgment, you will collaborate closely...

About This Role Every clinical trial depends on investigational medicine arriving at the right place, at the right time, and in the right condition. As Clinical Supply Lead Specialist – Bulk Logistics & Quality, you will play a key role in making that happen for Biogen's clinical programs, across two areas. In Bulk Logistics, you will plan and manage the global movement of drug substance, drug product, and finished goods between manufacturing sites, contract partners, and warehouses, working closely with planners, manufacturing, quality, and logistics partners around the world. In Quality Operations, you will help keep our clinical supply operations...

This position works out of our Pomona, CA location in the CMI Business Unit , 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 Supplier Quality Engineer will be responsible for quality engineering activities that address product/process changes, product/process quality issues, and compliance issues. This person will partner with operations for process improvement and continuous improvement initiatives and perform process audits of the operations...

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