Quality & Regulatory Jobs in Pharma & Biotech

The Associate Director, CMC Regulatory Affairs, Biologics executes multi-product global regulatory CMC strategies for investigational and marketed products, with a focus on biologics. 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 or mentor other regulatory staff. Key Duties and Responsibilities Leads the preparation and review of CMC sections of regulatory submissions, as well as the interactions...

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

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

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...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Contract Compliance Analyst III will facilitate contract implementation and revenue pull-through activities, both proactive and reactive, with internal and external parties. This position will ensure the public and private payer reimbursement. The role is also fundamental in...

Johnson & Johnson is hiring for a Manager, Regulatory Affairs – Shockwave Medica l to join our team. The position is FULLY REMOTE and can sit anywhere in the US . Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local...

Johnson & Johnson is recruiting for a Senior Director, BWI Quality & Compliance to support our Cardiac Electrophysiology business. The role is based in Irvine, CA. POSITION SUMMARY Head of Quality, responsible for ensuring effective implementation of BWI Quality Management System. RESPONSIBILITIES In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position Leads BWI Worldwide Quality functions, setting the strategies and goals in accordance with applicable regulatory requirements. Johnson and Johnson Enterprise, Medical Device and CSS policies and goals. Product Quality – Oversees directly and indirectly organization of Quality professionals,...

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

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. This is a key role on the Shop Floor Quality Assurance team. As Manager, Shop Floor Quality Assurance, Cell Therapy ,...

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

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. This is a key role on the Shop Floor Quality Assurance team. As Manager, Shop Floor Quality Assurance, Cell Therapy ,...

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

to make a real difference in the lives of many About Lingo Abbott's rich history in developing cutting-edge health technologies is evolving with its new venture into b iowearables . The b iowearables segment is poised to represent the future of the organization, with the potential to generate over $1 billion in revenue within the next five years, supported by Abbott’s robust R&D and financial resources. At Lingo, we are committed to transforming health management with our cutting-edge biowearables that monitor glucose levels and other critical metabolic biomarkers. Our products integrate seamlessly with other health indicators such as sleep, exercise,...

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our team is looking for a Customs and Trade Compliance Analyst to be based out of our office in Irving, TX or North Chicago, IL. This new team member will provide technical and analytical support for customs and trade compliance matters at the site/division level, ensuring compliance with all relevant customs...

This position works out of either Abbott Park, Illinois or Willis Tower, Chicago, IL location within the Global HR Services Team as a HR Data Privacy and Compliance Analyst. This position offers high visibility to senior HR leadership and provides a strong foundation for future growth into broader Security, Compliance, or HR roles. The HR Data Privacy and Compliance Analyst will collaborate closely with HR colleagues, affiliate teams, and technical partners to drive the strategy, execution, and continuous improvement of data privacy and compliance practices across the HR technology ecosystem. This role plays a critical part in safeguarding employee data...

This position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. We are seeking a passionate Manager in Quality Engineering to lead and develop an engineering team responsible for operations quality, design changes, transfer projects, and post-market surveillance within assigned product areas. The manager will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring...

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 Quality Control Engineer Co-Op to be in Gurabo, PR . The typical Co-op term is from January, 2026 to January, 2027 Full time requirement (40 hours per week) Purpose The incumbent...

OBJECTIVES (Briefly summarise the overall purpose of the position. Objectives should be written in 3 – 4 bulleted statements). Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorisation activities in the commercial business units and affiliates. Contributes to and implements the engagement strategy among R&D, Business Units and affiliates and Quality to ensure a global framework and robust quality systems are in place for the transition of R&D pipeline to the commercial space. Drives a fit-for-use global Quality framework that elevates the capabilities in the business units and the affiliate and enables them to deliver their clinical...

About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis, and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit Acadia.com and...

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

We are searching for the best talent for a Regulatory Affairs Specialist II to support our Spine group. This role will be based in our Raynham, MA office and will work a Flex/Hybrid schedule with 3 days per week in office . There is NO remote option. You will be responsible for Provides regulatory guidance to product development teams in defining regulatory strategies, pre-marketing, and related submissions to support optimal timelines for new/modified product launches in the global market. Execute on the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, including, but...

Biosense Webster a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer located in Irvine, CA! 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 Under general supervision, participate in new and sustaining product/process teams to support design verification tests, process validations, quality processes. Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance...

Johnson & Johnson MedTech Research & Development Quality (RDQ) is recruiting for Clinical Supplier Quality Manager. The preferred locations are Raritan, NJ, Titusville, NJ, Bridgewater, NJ, West Chester, PA, Bridgewater, MA, Spring House, PA; Warsaw, IN, Raynham, MA; Jacksonville, FL, or Irvine, CA. However, the role can be performed at any location in the US. Remote work options may be considered on a case-by-case basis and if approved by the company. 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...

Biosense Webster a member of Johnson & Johnson's Family of Companies, is recruiting for an Eng Quality Engineering located in Irvine, CA! 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 Senior Quality Engineer – plans, coordinates and executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Involved in New Product Development (NPD) teams and other activities to develop products, design...

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 Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing...

Use Your Power for Purpose We are committed to bringing medicines to the world at a faster pace without compromising on excellence and integrity. Navigating the ever-changing regulatory environment compliantly requires forward-thinking and meticulous attention to detail. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer medicines and vaccines. Lead/support the management of deviations within the QMS process for WSR including qualification and/or triage of significant quality events within WSR. Provide support to Quality Event/CAPA and Commitment Leads/Owners and serve as conduit between BPOs, business lines, quality groups and governance groups to enable and promote...

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

Provide the necessary oversight and support for import and export recordkeeping to ensure documentation and processes meet regulatory requirements and corporate policies. Provide training and analytical support for customs and trade compliance matters at the site/division level, ensuring compliance with all relevant customs regulations and trade laws and regulations, including 19CFR, 15CFR, FDA, USDA, and other US regulatory agency requirements. What You'll Do Applies basic working knowledge of import and export regulations and requirements to support business needs. Ensure timely and accurate response to Broker Requests for Information and follow-up to ensure resolution. Monitor clearance process for all US imports...

This position is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives. As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels. As a Senior Specialist Import & Export, you will provide subject matter expertise to ensure site compliance with all relevant customs regulations and trade...

Quality Engineer II - 2nd shift This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer II, you’ll have the chance to assure products, processes, and quality records conform to quality standards and establish compliance within Abbott's quality system on the manufacturing floor. We need you to be responsible for maintaining a strong collaborative partnership with multi-functional teams. Help facilitate success...

Manages the day to day Chemistry, Manufacturing and Controls (CMC) regulatory activities for one or more development and/or marketed projects and through this is responsible for achieving results that impact the success of the department and company. _ Your Contributions (include, but are not limited to) Manages several projects simultaneously with an emphasis on CMC while adapting to changing project priorities Maintains all CMC aspects of US regulatory filings and clinical trial applications outside the US, ensuring that they remain compliant with all applicable regulations and relevant guidelines (domestic and international) Assists and provides guidance to other departments and submission...

Medtronic – Milwaukee, WI manufactures spinal implants and Brain/ENT instrument components. As a member of Supplier Quality Engineering, you will be responsible for management of external suppliers to Medtronic, Milwaukee. You will lead oversight of supplied products, ensuring conformance to purchased material requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 5 days a week onsite...

Johnson & Johnson is recruiting for a Senior Director, Quality Experience Engineering to support the journey of delivering the next generation of medtech solutions. The role can be in any of US medtech manufacturing or R&D site on a Hybrid schedule. Raynham, MA Raritan, NJ Bridgewater, NJ West Chester, PA Jacksonville, FL Irving, TX Irvine, CA Santa Clara, CA Palm Beach Gardens, FL Position Overview As a key leader within the organization, you will be responsible for developing and executing strategies to enhance customer experience through innovative quality engineering solutions and continuous improvement initiatives. This role demands a strategic approach...

The Manager Labeling Regulatory Affairs Strategic Labeling, develops and maintains US/EU package inserts and Company Core Data Sheets and coordinates review and approval of these documents with changing regulatory environments. Leads discussions to ensure global consistency of labeling. Educates team members concerning global consistency of labeling. Responsibilities Leads teams on labeling decisions based on knowledge of processes and regulations. Educates others as to new labeling regulations regarding Company core Data Sheet (CCDS), US Package Insert (USPI), Summary of Product Characteristics (SmPC), Structured Product Labeling (SPL) , or Instructions for Use ( IFUs) Collaborates with cross-disciplinary teams, including engineering and device...

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

Supplier Development Quality Engineer II This position works out of our St. Paul, MN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Supplier Development Quality Engineer II , you’ll have the chance to develop components and associated quality requirements for new product initiatives. This position is responsible for managing supplier relationships, qualifying components and developing incoming controls that will drive the quality of future components. This will include technical support...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at . We are searching for the best talent for a Quality Technician III. Purpose An individual contributor that executes routine tasks with limited supervision and more complex tasks with support. Executes day-to-day activities such as equipment setup, metrology support, and general housekeeping. Maintains good documentation practices. Performs instrument qualification/validation activities and lab investigations, and data review and metrics reporting. Identifies improvement opportunities...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. The Associate Director, Ethics & Compliance Advisor reports to the US Ethics and Compliance Head and responsibilities include Work with the Senior Director advising Liver Commercial to provide expertise in healthcare compliance, ensuring that activities align with the highest ethical and compliance standards. Partners with leaders across Gilead to build and integrate the compliance program into Gilead’s organization and to embed compliance and integrity into Gilead’s culture. Help drive global consistency in our compliance program and ensure best practices are...

Careers That Change Lives In this exciting role as a Senior Quality Systems Manager, you will have responsibility for QMS Data Analytics, Data Reporting and managing multiple Digital based improvement initiatives within the Quality Transformation organization that will systematically evaluate and transform the capability of the Quality Management System (QMS) to better meet the needs of its stakeholders, both internal and external. Diabetes The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly...

Medtronic – Warsaw, IN manufactures spinal implants and Brain/ENT instrument components. In this exciting and fulfilling role the Quality Engineer I will be responsible for providing quality support to the product value stream, ensuring that customer and patient needs are met every day. They will be part of a passionate team dedicated to ensuring our products meet the highest standards. The Quality Engineer I role is critical in supporting key department metrics, which contributes to the global strategy while delivering on our mission to manufacture products of the highest quality that alleviate pain, restore health and extend the life of...

The Senior Validation Engineer will be responsible for equipment/facility validation projects in a hands-on role including writing validation protocols, completing data sheets, scheduling and performing validation tests, gathering and analyzing data, and writing final validation reports KEY RESPONSIBILITIES Identify systems requiring validation. Lead the development of required validation procedures and practices with respect to the facility. Develop validation project/assignment detailed schedules to coincide with the milestones on the master plan. Design and implement required validation studies and protocols for the facility and equipment as per required schedules. Coordinate and lead resources required to complete validation studies and tests in a...

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...

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

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

COMPANY BACKGROUND& CULTURE Johnson & Johnson (J&J) is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the consumer, pharmaceutical, and professional markets. J&J employs approximately 126,500 people worldwide, deployed in more than 250 operating companies in 60 countries. Products are sold throughout the world and serve a broad segment of medical needs ranging from baby care, first aid, and hospital products to prescription pharmaceuticals, diagnostics, and products relating to family planning, dermatology, and feminine hygiene. Johnson & Johnson and its subsidiaries have built the most comprehensive base...

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

We are recruiting for a Regulatory Affairs Specialist I to join our team on-site in Santa Clara, CA or St. Paul, MN. As an individual contributor, the function of a Regulatory Affairs Specialist I 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. What You’ll Work On Analyzes the input of cumulative product changes to current product submissions. Shares knowledge...

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

Careers that Change Lives A career Medtronic is currently searching for a Sr. Principal Quality Engineer to join the New Product Development team at the Lafayette, CO facility. You’ll play a crucial role in supporting our Surgical business unit by ensuring that our suppliers deliver high-quality parts, materials and service. You will also participate in design transfer and manufacturing quality activities. Key Responsibilities Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services. Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems. Experience with PCBA suppliers and validation of PCBA test...

Job Purpose This position is focused on regulatory policy to ensure appropriate and effective regulatory policy development as well as developing and advocating for BMS’s position externally. As part of the team, the Associate Director Regulatory Policy brings an expertise in regulatory affairs and related policy. The Associate Director, Regulatory Policy is responsible for driving regulatory policy mapping, advocacy, clear objectives and actionable outcomes. The incumbent acts as a critical link between global, regional, and local regulatory environments, ensuring the business stays ahead of evolving regulatory policies. A core aspect of the role is driving long term policy goals that...

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our flexible, innovative, and customer-oriented quality culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of...

ETHICON, Inc., a member of Johnson & Johnson's Family of Companies and located in Cornelia, Georgia, is recruiting current college students for their Engineering Co-op Program. This position is designed for current college students. The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars, energy devices and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy...

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

Principal Software Quality Engineer Medtronic ENT (Ear, Nose, and Throat) is an operating unit within Medtronic’s Neuroscience Portfolio. We focus on providing innovative solutions for ENT conditions, including surgical and therapeutic products designed to improve patient outcomes in ear, nose, and throat health. We are currently offering an excellent opportunity to join the ENT Quality team as a Principal Software Quality Engineer . This position is based onsite in Jacksonville, FL . Role Overview In this role, you will serve as an individual contributor responsible for ensuring the quality of software design and development for medical devices and related software...

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Senior Manager, Compliance and Quality Risk Management at RayzeBio serves as the Local Process Owner for Risk Management and Data Integrity, responsible for driving consistent, compliant, and risk-based practices across the site. This leadership role ensures alignment...

Position Senior Specialist, Field Quality Location Devens, MA 12 Hrs. rotational shift 500 am to 530 pm Key Responsibilities Quality floor support of complex manufacturing activities for Large Scale Cell Culture (LSCC) facility. Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs. Perform walkthroughs of GMP areas documenting observations and areas of concern. Perform training on routine facility Quality tasks for new team members. Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed. Assures all electronic and paper documentation, which requires QA review is in compliance...

Join Us in Shaping the Future of Animal Health Our Animal Health division is investing $895 million in expanding our manufacturing and research & development facilities in De Soto, Kansas — the state’s largest economic development project to date. As a US Regional Project Quality Lead you will be part of a world-class team at our Center of Excellence in the Animal Health Corridor, contributing directly to the production of veterinary products that improve animal health and welfare globally. Key Responsibilities Acts as the QA/QC lead in establishing the quality assurance, quality control and compliance foundation in future project operations....

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

The Director, International Regulatory Affairs Advertising & Promotion safeguards products and practices to adhere to the highest quality and regulatory standards. The Director will design and deliver optimized global regulatory strategies, plans and dossiers that align with AbbVie’s overall business strategy. The Director is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds.The Director will interface with International Marketing, Global Legal and Office of Ethics and Compliance with regard...

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Senio r Quality A uditor is responsible for planning, executing, and reporting on internal and external audits to ensure compliance with applicable GxP regulations (GMP, GLP, GCP), internal procedures, and industry standards. This role supports the continuous improvement...

Director- Site Quality Head The Opportunity Abbott Diabetes Care has an opportunity for a Director - Site Quality Head. The Director leads strategy, management and support for global supplier quality associated with the division. Areas include suppliers (parts and services), Third Party Manufacturers (TPM), and Original Equipment Manufacturers (OEM), service providers and consultants. Establishes quality systems and plans for supplier controls to assure design, development and manufacture of the highest quality products to exceed customer requirements. Interfaces with outside regulatory agencies. What You’ll Work On Champions quality and compliance through awareness of requirements, trends and other external influencing factors especially...

Medtronic – Warsaw, IN manufactures spinal implants and Brain/ENT instrument components. In this exciting and fulfilling role the Senior Quality Engineer will be responsible for providing quality support to the product value stream, ensuring that customer and patient needs are met every day. They will be part of a passionate team dedicated to ensuring our products meet the highest standards. The Senior Quality Engineer role is critical in supporting key department metrics, which contributes to the global strategy while delivering on our mission to manufacture products of the highest quality that alleviate pain, restore health and extend the life of...

As a quality inspector at the Billerica site, you will work as part of a high-performing team in the cleanroom, inspecting catheters used in cardiac ablation procedures. Your attention to detail and commitment to quality will help ensure our products meet the highest standards for patient safety. Schedule Monday - Friday, 10 pm - 630 am (3rd shift / overnight) Environment Cleanroom standards apply. PPE is provided and must be worn in the manufacturing area. Compensation Base hourly rate $24/hr + $3/hr shift differential Quarterly Operations Incentive bonus PTO - 4 weeks / year Paid holidays - 10 / year...

Responsibilities may include the following and other duties may be assigned. Support review of advertising and promotional material to ensure that it meets all medical, legal, and regulatory (MLR) process requirements. Facilitate review meetings online and offline coordination with authors, reviewers/approvers to get content approved to support business needs. Act as SME for Neurovascular Ad Promo process, providing guidance to authors and reviewers on regulatory and internal policy requirements. Support the preparation of US and International promotional labeling material, including the creation of a claims matrix database and claims objects. Lead AI/ML adoption in content and claims management to support...

OBJECTIVES/PURPOSE Provides governance and oversight to all GxP Engineering and associated Equipment validation activities including Facility Engineering standards, Maintenance and Calibration processes, Commissioning, Installation, Operational, and Process Qualifications at Takeda to ensure compliance with GxP regulatory and quality standards while maintaining the integrity of data Oversees Business Processes and partners with Business Process Owners for applicable Validation activities to ensure consistency of approach across the network, including validation site master plans Ensures consistent use of applicable North Star systems to capture engineering and associated validation activities, such as installation and operational qualifications (IQ/OQ), Process qualifications (PQ) and...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities—including small molecules, biologics, and external manufacturing sites—the role employs an agile approach to drive standardization, scalability, and sustainability. This position leverages ICH Q12 principles to streamline...

The Senior Manager, Regulatory Affairs, Device works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research & Development (R&D) organizations. Represents RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. Additional Responsibilities Include Prepares device regulatory product strategies. Prepares and manages regulatory submissions, including new applications...

The Senior Manager, Regulatory Affairs, Device works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research & Development (R&D) organizations. Represents RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. Additional Responsibilities Include Prepares device regulatory product strategies. Prepares and manages regulatory submissions, including new applications...

Purpose The Sr. Manager, Quality Strategy and Data Analytics will be accountable supporting the creation of the site and/or global Quality Strategy and the successful delivery of assigned programs and projects, and the overall delivery of the Quality Strategy. The role will serve as a key contributor in end-to-end project/program objectives and outcomes, especially driving efficiency and agility with a strong focus on automation and utilization of digital tools (e.g., AI). This role will drive and support projects across the site and/or global quality functions and will identify and communicate opportunities to their respective leadership teams. Additionally, this role will...

We are seeking a Senior Director, GxP Quality to lead and scale quality strategy and operations across our development-stage programs. This is a key leadership role responsible for building and maintaining phase-appropriate quality systems across GCP, GLP, and GMP activities. The Senior Director will partner cross-functionally with Clinical Development, CMC, Regulatory, Technical Operations, and external partners to ensure compliant execution of Generate’s drug development strategy, with their primary focus on clinical quality assurance in the late stage. The ideal candidate brings deep technical expertise, a pragmatic mindset and hands-on approach, and the ability to lead quality initiatives in a lean,...

This position works out of our Sylmar, CA location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. We are seeking a high caliber Software Quality Engineer I. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. Work requires the application of theoretical engineering principles, evaluation, ingenuity and creative/analytical techniques typically acquired...

Job Title Electrical Development Quality Engineer II Our location in Sylmar, CA currently has an opportunity for an Electrical Development Quality Engineer II . This is a fully onsite role . A Development Quality/Design Assurance Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias,...

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

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

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. We are seeking a highly motivated Senior Manager to join the Global Supplier Quality team within External Quality Operations. This position will support Biologics (e.g., single-use systems, resins, filters, media, excipients) material categories. The role is designed to provide hands-on operational execution and external relationship management for the material categories. The individuals will manage global changes, investigations, and onboarding activities, while also growing into broader leadership roles over time. The role is highly visible, offers tremendous growth potential, and requires...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. We are seeking a highly motivated Senior Manager to join the Global Supplier Quality team within External Quality Operations. This position will support Parenteral Packaging (e.g., vials, syringes, stoppers) and Device categories . The role is designed to provide hands-on operational execution and external relationship management support for the material categories. The individuals will manage global changes, investigations, and onboarding activities, while also growing into broader leadership roles over time. The role is highly visible, offers tremendous growth potential, and...

The Sr. Principal Analyst, Quality Systems plays a key role within the QARA (Quality and Regulatory) Technology function. The role will be a key technical resource overseeing the Quality Batch Disposition system. Primary responsibilities include gathering and refining requirements, determining options for solution design, supporting integrations, maintaining system operations, and delivering enhancements. Key Duties and Responsibilities Serve as the platform owner for an integrated quality batch disposition system. Implement and manage data and technology solutions across Vertex Quality, with focus on integrated quality batch disposition system. Lead installation, configuration and troubleshooting processes for integrated batch disposition Conduct data quality assessments,...

Vertex is in an exciting time of growth and innovation, and technology and data are valued as strategic assets. The Data & Software Engineering team in the Data, Technology and Engineering (DTE) organization is seeking an experienced technology lead to help create, maintain, and implement the technology strategy, platforms and applications that enable data quality (DQ) across the enterprise. As the Associate Director, Data Quality, you will report to the Director, Data Governance and be responsible for building and managing data quality platforms, processes and strategy. You will work across the organization with data engineers, analysts, data stewards and product...

Responsibilities may include the following and other duties may be assigned. Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems. May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products. Oversees the investigation and evaluation of existing technologies. Guides the conceptualization of new methodologies, materials, machines, processes or products. Directs the development of new concepts from initial design to market release. Manages feasibility studies of the design to determine if capable of functioning as intended....

GSK is currently looking for a Quality System & Data Associate Director to join our team in Rockville, MD. The Quality System & Data Associate Director provides leadership to a team of Quality professionals and is critical in overseeing data integrity and governance, document control, training compliance, Quality Management System (QMS) deployment, as well as defining and driving the site Quality Improvement Plan. The role also includes responsibility for driving GPS for Quality, Quality Culture and embedding Digital Strategy into the Quality organization. The Quality System & Data Associate Director reports to the Site Quality Director and is part of...

EM and S Vaccines and Large Molecules GenMed Head of Transversal Quality Location Cambridge, MA, Framingham, MA, Morristown, NJ About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. External Manufacturing & Supply Vaccines and Large Molecule GenMed is responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in...

About the role The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of processes and product outputs. This role involves defining and specifying activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's mission to provide better health and a brighter future. This role can be located in Cambridge, MA or Zurich, Switzerland and is Hybrid (not remote). R elocation Benefit is available to support your transition. How will you contribute Ensure compliance to Regulatory Intelligence Procedures...

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

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. Quality & Compliance Internship Program Overview The Quality and Compliance organization within the Enterprise organization for the Med Tech and Innovative Medicine sectors are seeking highly motivated...

The Associate Regulatory Affairs Director (RAD) , Regulatory Science & Execution will be accountable for the develop ment, implement ation and maintenance of regulatory strategies for assigned project(s)/ product (s) and regulatory jurisdiction ( s ) , with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will provide tactical and strategic input to and leadership across regulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure effective communication and constructive working...

Do you have expertise in, and passion for Patient Safety? Would you like to apply your expertise to provide medico-scientific and clinical strategic leadership in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Working with one of the broadest and deepest OnDo cology pipelines in the industry offers the...

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

The Associate Director of QC Raw Materials manages and directs the Vertex cell and gene therapy raw materials team. This position will provide leadership and technical expertise in Quality Control Raw Materials Program Management. The role is responsible for leading other QC personnel, optimizing Department resource allocation according to project/program needs to assure testing activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values Key Responsibilities Develop and execute the QC Raw Materials program strategy for in-house manufacturing of Vertex Cell and Genetic Therapies. This position requires strong partnerships with process development(PD), Supply Chain...

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of three key businesses Cardiac Pacing Therapies, Defibrillation Solutions, and Cardiac Diagnostic Services. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward...

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth...

As a Sterile Operations, Validation Leader, you will provide guidance and direction to a team of Validation Professionals supporting the construction, start up, commissioning, and qualification of an R&D, clinical manufacturing, Drug Product filling facility. The new DP facility as well as this position will be located in Marietta, Pennsylvania. After the facility is released for GMP manufacturing, the role will include routine validation support of the facility including, but not limited to validation maintenance, Change Control management, new equipment / system introduction, decommissioning, and other validation life-cycle requirements. This role requires consistent and continuous on-site presence. Although the role...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was...

Job Tite Summer 2026 Intern - Validation Team Location Swiftwater, PA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Our team is looking for a summer intern to assist in lab experiments, development and validation studies for cleaning and shipping validation with different vaccine products. In addition, the intern will also support collecting and analyzing...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The selected candidate will join Sanofi's Manufacturing and Supply – Vaccines division as a Quality Control Virology intern at the Swiftwater facility, gaining valuable hands-on experience in vaccine testing processes while contributing to our mission of protecting global health. As a QC Virology Intern, the candidate will support our team...

This Regulatory Affairs Project Manager position is an onsite opportunity working out of our St. Paul, MN location in the Abbott Vascular Division. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. In collaboration with the Regulatory leadership, develop and implement regulatory strategies that will ensure earliest possible introduction of product(s) into domestic and international markets. Additionally,...

This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Casa Grande, AZ., is one of Abbott’s leading nutrition manufacturing plants in the U.S., reflecting our commitment to innovation and excellence. But we’re more than just a...

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

We are seeking a Principal Regulatory Affairs Specialist to join Abbott’s Vascular Division on-site in St. Paul, MN. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. The individual may...

This position works out of our Plano, TX location in the Neuromodulation division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. This role performs inspection and testing of purchased materials, components and products in accordance with policy and procedures. What You’ll Work On Performs visual, dimensional and functional inspection and testing according to documented policies and procedures. Records inspection and test data as prescribed by written instructions and procedures. Recommends changes...

About the role This position holds ultimate responsibility for the overall Quality Assurance of Site Teardown and Fractionation Operations at Takeda’s Los Angeles Manufacturing Facility. The role is essential in ensuring that all quality-related activities meet regulatory standards and uphold Takeda’s commitment to excellence. The incumbent will work in close partnership with Manufacturing and Engineering Business Unit Leaders to ensure the timely implementation and ongoing maintenance of prevention-based Quality Systems. These systems include exception management, CAPA, Change Control, and Quality on the Shop Floor, all of which are critical to maintaining compliance and driving operational efficiency. Beyond quality oversight, the...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The intern candidate will be a member of Manufacturing Sciences, Analytics & Technology (MSAT), who's role is the technical guardian of manufacturing processes and technologies from product launch through their commercial manufacturing lifecycle. MSAT is known for its advanced expertise in Biotechnology, Chemistry, Pharmaceutical and Analytical Sciences, Process Design &...

About the role Associate Director, Clinical Program Quality Investigations is responsible for ensuring the compliance of deviation management and serious breach process. This role focuses on defining activities, processes, and standards to meet quality requirements relevant to deviation management and serious breach. This position supports Takeda's mission by maintaining high standards of quality and compliance in clinical trials. This role is located in Cambridge, MA and is Hybrid (not remote). R elocation Benefit is available to support your transition. How will you contribute Drive the implementation of clinical deviation management and Serious Breach process across Clinical Program Quality. Acts as...

Shire Human Genetic Therapies, Inc. is seeking a Quality Control Analyst II with the following duties test biochemistry analytical methods for release and stability samples using qPCR (Quantitative Polymerase chain reaction), Kinetic Activity, Osmolality, Specific activity, Enzyme Activity, A280-320 protein concentration, pH, visual inspection and Reconstitution methodology. Provide subject matter expertise to junior level analyst in the lab. Proficiently use pH Meter, UV Spectrophotometer and solo VPE (Visual path extension), M5 and 384 Plate readers, 7500 fast Real-time PCR (Polymerase chain reaction) system and Osmometer. Provide support on maintenance of lab instruments in support of GMP (Good manufacturing Practices) testing....

Use Your Power for Purpose At Pfizer, we are committed to bringing medicines to the world at a faster pace without compromising on excellence and integrity. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer vaccines. By maintaining high standards and adapting to regulatory changes, you will play a key role in ensuring that our life-saving treatments reach those in need promptly and safely. What You Will Achieve ROLE SUMMARY This Director, Global...

Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate...

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

Senior Manager, Quality Engineering -- Minnetonka MN This position works out of our Minnetonka , MN location in the Electrophysiology business. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Senior Manager Quality Engineering , you’ll provide leadership and guidance for the quality engineering department supporting commercial products and new product development. This role is responsible for developing goals, objectives, procedures, policies, and systems that are in line with company goals and objectives, mission and...

Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of QC leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QC Head. Responsibilities Lead the biologics site Raw Materials and Incoming Materials laboratory processes and programs for a high volume, high level of product complexity including multi products to ensure compliance with regulations including EU Annex 1, FDA Guidalines, EMA, ANSI, among others. Ensure robustness and approves investigations Raw Materials & Incoming, quality and process excursions...

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...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. R ESPONSIBILITIES Serve as a Lead Subject Matter Expert and Process Owner for assigned areas, processes, and technologies. Lead collaborations with CRO partners to ensure continuous improvement and alignment with Gilead’s RBQM framework, including representing RBQM in governance committees. Provide oversight of vendors performing RBQM activities, ensuring effective, high quality, and timely delivery of portfolio requirements. Support inspection-readiness and participate in audits and regulatory inspections, serving as a point of contact for RBQM. Study Risk Assessment and Mitigations Provide expert...

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s). USA (Raritan, Titusville, New Brunswick, Horsham) Req # R-029355 Belgium (Beerse) Req # R-029498 Switzerland (Schaffhausen) Req # R-029484 Ireland (Cork) Req # R-029498 The Vice President Quality Systems is responsible for providing high-level strategic oversight and direction for quality initiatives across the organization, including QMS, process ownership, capa/escalation and...

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

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...

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...

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...

This position works out of our Atlanta , Georgia location in the Heart Failure Division . In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Supervisor, Quality is responsible for the performance of his or her team and meeting any assigned project timelines and objectives. Keys to success include proper management of product support while ensuring quality and compliance of employees/equipment, promotion of a safe and positive work environment, constant pursuit of business excellence initiatives, successful management and development of...

This position works out of our Sylmar CA or Austin TX facily. What You’ll Work On Abbott is currently seeking an experienced professional to provide Provides direct oversight for moderately complex elements of Abbott’s compliance program at the franchise, business unit, regional, divisional, or corporate level. Responsible for directing the development and administration of OEC education and training, and development and implementation of divisional monitoring plan. Identifies compliance risk areas and recommends action plans to ECO or direct management. Responsible for direct compliance support of key business activities for the applicable business unit. Responsible for direct compliance support to e.g....

That’s what makes us Roche. The Opportunity As the site Data Integrity & Quality Governance Lead, you will be responsible for supporting the data integrity related programs governing compliance to all applicable regulations and guidances, both external and internal (e.g., 21 CFR 211, 21 CFR Part 11, EudraLex Volume 4 Part I, II and Annex 11, ICH Quality Guidelines, Industry Standards, GSP005, GSP006, Network and Local SOPs). You will be responsible for helping to provide oversight of the site data integrity program, and supporting initiatives with respect to data management, governance, integrity, issue resolution and quality. You will be responsible...

As a Quality Technical and Validation Manager, you will be responsible for overseeing the technical quality assurance and validation activities to ensure compliance with regulatory requirements, industry standards, and GSK policies. You will play a critical role in maintaining the highest levels of product quality and safety. This role leads a team that has responsibility and accountability for ensuring the highest standards of GxP compliance in the validation and qualification of processes, equipment, and systems within GSK's manufacturing and analytical environments. This includes overseeing new product introductions (NPI) and associated manufacturing and analytical activities, ensuring seamless introduction of products from...

Are you ready to help advance healthcare innovation? J&J is recruiting for a Global Design Lead (data design and process design), reporting into QC Operations in Raritan, 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...

This position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. As a Supervisor Quality Assurance, main responsibility will include ensuring the quality standards and procedures are upheld in all site and operational processes. Role expectations will include leading a team in monitoring, evaluating, and improving operational efficiency and effectiveness while maintaining compliance with regulatory requirements and company standards. What You’ll...

This position works out of our Alameda, CA office in the Lingo Division. 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. This position is responsible for activities related to design control; qualification; specification and corrective and preventative action of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. What You’ll Work...

What you will do In this role the Senior Engineer position reports to the Sr, Manager of Validation. This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations in the Amgen Ohio facility. Functions The Senior Engineering will support the development and implementation of automated and semi-automated combination product assembly equipment initiatives as part of the Finished Drug Product (FDP) product portfolio at the Amgen Ohio manufacturing site. The position is a key role in the Process Development team where the candidate must manage and/or apply...

Job Responsibilities Lead in the development and implementation of quality strategy and associated capabilities to support the CDS objectives Manage quality review of clinical trial documents, workflows, and outputs within the CDS organization to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations Analyze trends to identify process gaps, improvement opportunities and areas requiring corrective/preventive actions Lead new quality focused initiatives focused on new learnings, findings, and observations to continuously improve CDS quality practices and methods Work closely with Gilead CDS study team to provide expert advice on compliance issues and risk mitigation actions...

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and...