Quality & Regulatory Jobs in Pharma & Biotech

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

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 . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized...

The Associate Director of Compliance will report to the Large Molecule Regional Quality Lead, Americas. The responsibility of this position is across all Animal Health operating units and requires extensive collaboration with manufacturing sites, contractors, and suppliers. Primary Responsibilities Provide Subject Matter Expertise to ensure our company’s manufacturing sites adhere to compliance standards established in 9CFR and enforced by USDA-APHIS-CVB Inspection and Compliance (IC), and Policy, Licensing and Evaluation (PEL). Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements for facility design, auditing, quality systems and ensure team and company adherence to these documents. Develop 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. Organization Overview At Lilly, we serve an extraordinary purpose. We make...

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 At Lilly, we serve an extraordinary purpose. We make...

About the role Join Takeda as a Senior Manager, USBU Ethics & Compliance Learning & Engagement, where you'll champion ethical behavior and help mitigate risk through impactful learning, communications, and digital innovation. Reporting to the Ethics & Compliance (E&C) Learning & Engagement Head, US Business Unit (USBU), you'll collaborate across Global E&C teams and partner with business stakeholders to design engaging training, manage strategic communications, and lead key projects like SharePoint site development and training dashboards. This dynamic role blends creativity and technology—leveraging tools like Articulate 360, Vyond, and AI—to simplify processes and enhance compliance across the USBU organization. How...

About the role As Head of Global Quality Systems Operations, you will set the strategic direction and ensure consistent excellence in our global quality management systems. You’ll lead the continuous improvement and digital transformation of quality processes at Takeda, working collaboratively across business units and regions. Your leadership will support compliance, operational effectiveness, and the successful evolution of our Global Quality organization. How you will contribute Lead and continuously enhance Takeda’s global One Quality Management System and digital platforms, driving innovation and compliance with evolving regulatory standards. Develop and maintain strong governance and business process frameworks for key quality systems,...

About the role As Senior Validation Engineer, you will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. You will report to Head of Engineering Services. This is an on-site position, and you will be required to work all five days from the office. How you will contribute Be a Validation Engineering representative and technical subject matter expert (SME)...

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...

This position works every day on site out of our Carlsbad, CA location in the Cardiometabolic Division in Abbott Rapid Diagnostics. 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. What You’ll Work On This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. In addition...

Medtronic is seeking detail oriented assemblers with quality inspection and documentation review experience to join our team in Billerica. This critical position requires a strong quality focus and attention to detail. SAP experience preferred. Schedule Monday - Friday, 200 pm - 1030 pm Compensation Base hourly rate $24/hr Quarterly Operations Incentive bonus PTO - 4 weeks / year Paid holidays - 10 / year 401(k) with up to 60% match Comprehensive benefits plan, including medical, dental, vision, and more Fully subsidized Bachelors degree programs paid up front! Paid family, medical, and parental leave Responsibilities may include the following and other...

Regulatory Affairs Analyst Main responsibilities Support the execution of Regulatory Strategy. Implement the regulatory strategy for assigned products by processing registrations, renewals, post-approval changes, and promotional materials to obtain required health authorizations for business units. Ensure Complete Regulatory Submissions. Guarantee submission of complete dossiers to local health authorities through effective preparation and review processes to obtain timely approvals. Maintain Global Data Systems. Register product-related information in global electronic systems (Veeva Vault RIM, Qualipso, 4M PromoMats, OnePack) to comply with Sanofi's global guidelines. Manage Documentation and Archives. Compile physical and electronic product dossier files by creating comprehensive backup documentation of all...

Johnson and Johnson is recruiting for a Senior Manager Quality Control Operations! This position can be based in Malvern or Spring House, PA. 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 Are...

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 . Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready...

Company Overview Job Responsibilities Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Responsible for submitting moderately complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs for assigned territories. Responsible for preparation of the Company Core Data Sheets (CCDS) for assigned products and ensures that any updates to the CCDS and the Product Company Core...

Senior Manager, Global Regulatory Diagnostics Strategy for Oncology You will represent Pfizer as an approval liaison in the regulatory affairs team assisting with diagnostics regulatory tasks. You will play the critical role of providing regulatory strategic direction to teams overseeing clinical development of products and diagnostics. This will involve interacting with regulatory agencies and diagnostics partners, including negotiations to expedite regulatory approval of trials co-developing medicinal and diagnostic products. Through your expertise, you will be the diagnostic regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing, commercialization, research project teams and government...

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’s Purpose At Lilly, we unite caring with discovery to make...

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 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. Your unique talents...

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 matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease. Click here to...

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). Responsibilities may include the following and other duties may be assigned. Lead and execute reliability testing to ensure hardware products meet and exceed quality standards. Perform De-Rating analysis to evaluate component stress levels and ensure long-term durability....

Job Purpose Responsible for the CMC regulatory activities in the commercial lifecycle management of GSK products. Key Responsibilities Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities. Responsible for CMC strategy development, with managerial support, for CMC submission documents to support marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards. Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of global CMC applications. Ensures all appropriate CMC...

This role offers an exciting opportunity to lead and deliver Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for vaccines. You will manage global CMC regulatory activities across development, registration, and lifecycle management. Collaboration is key, as you’ll work closely with cross-functional teams to ensure compliance and drive innovation. We value candidates who are proactive, detail-oriented, and skilled at navigating complex regulatory environments. This role is based in the US at one of these locations Rockville, MD, Upper Merion, PA or Durham, NC. 2-3 days on-site per week average presence is required. Responsibilities Develop and implement CMC regulatory strategies for vaccines,...

This position works out of our Irvine, CA location on our EP (Electrophysiology) Quality team. Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements. What You’ll Work On Contributes to the development, maintenance and improvement of division supplier development quality program policies, procedures and forms. May provide coaching and mentoring for technical team personnel. Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers...

This position, Sr. Quality Engineer, works out of our Lake Forest, IL and Willis Tower, IL location in the CMI Division. 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. As a Quality leader, your 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...

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. Position Associate Director - Quality Engineer Position Type Full-time Location...

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...

Johnson & Johnson is recruiting for a Quality Engineer 2 NPD to work in our Irvine, CA location. Under general supervision, participate in new and sustaining product/process teams to support design verification tests, process validations, quality processes. Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards. As needed, assists to develop quality-engineered systems and products, and support qualification and validation activities. Will work on complex problems and projects. Will show leadership...

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 Manager, Quality Engineering at the Cell Therapy Facility (CTF) in Devens, MA will be responsible for providing Quality oversight of...

At Johnson & Johnson Innovative Medicine, we use heart, science and ingenuity to create transformational medicines to improve the health of humanity. Every day, we work to advance scientific research and commercial innovation, to deliver solutions that provide value to patients, physicians and healthcare systems around the world. With a diverse company culture, we celebrate the uniqueness of our employees and are committed to inclusion. We collaborate with the world for the health of everyone in it. Global Regulatory Affairs (GRA) is looking for a high energy, inventive, self-starter intern for its 2026 program. We offer an exciting immersive summer...

That’s what makes us Genentech, a member of the Roche Group! Product Development Regulatory (PDR) is a flexible, bold, and distinctive regulatory organization. We are accountable and responsible for providing the framework to effectively understand, assess and influence the rapidly evolving regulatory landscape. The opportunity As a Regulatory Intelligence Specialist you will be a key contributor to our regulatory strategy by proactively monitoring, analyzing, and interpreting the evolving global regulatory landscape across multiple therapeutic and disease areas. You will translate complex regulatory information—such as new health authority guidances, competitor activities, and emerging policy trends—into actionable insights for project teams. You...

Purpose This position leads and maintains compliant Documentation Quality Systems (QS) according to AbbVie policies, procedures, and applicable government regulations by managing the documentation review board to process and update complaint plant procedures, Process Control Records, Specifications, Test Methods, and other GMP documentation. It also provides leadership to a team for the creation and/or update of material codes in the SAP inventory system and the electronic batch record recipes in POMs system. The Quality Systems and Third-Party Contractor (TPC) role also is the main QA point of contact with TPC to manage regulatory compliance and business continuity requests in a...

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

Kickstart Your Career at Vertex! Are you ready to make a real impact? At Vertex, our mission is to tackle serious diseases and to change lives, for the better, for the future. Our aim is to give you the skills, insights, and career guidance to be an important part of that future; to turn your potential into progression. As a Vertex intern or co-op, you’ll work on meaningful projects, collaborate with talented teams, and learn from industry leaders. We’re passionate about innovation, inclusion, and supporting your growth—inside and outside the lab. Why Vertex? Real Projects You’ll work on assignments that...

Kickstart Your Career at Vertex! Are you ready to make a real impact? At Vertex, our mission is to tackle serious diseases and to change lives, for the better, for the future. Our aim is to give you the skills, insights, and career guidance to be an important part of that future; to turn your potential into progression. As a Vertex intern or co-op, you’ll work on meaningful projects, collaborate with talented teams, and learn from industry leaders. We’re passionate about innovation, inclusion, and supporting your growth—inside and outside the lab. Why Vertex? Real Projects You’ll work on assignments that...

Do you thrive at the intersection of regulatory expertise and digital innovation? As the Strategic Initiative Lead, you will turn bold ideas into validated opportunities, transforming concepts into business-ready solutions that future-proof Sanofi’s Global Regulatory Affairs (GRA). Reporting to the Head of Engagement & Innovation, you will lead initiatives at the validation and acceleration stages of our innovation funnel, working closely with Innovation Leads, Business Process Owners, Capability Heads, and Digital partners. By applying your deep regulatory knowledge and proven leadership skills, you will guide high-risk, high-reward initiatives through uncertainty - framing the right problems, validating assumptions, and building 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 Global Quality Risk & Alert Management team (QRM-QAM team) is composed of two groups one managing proactive risks and the other managing Quality Alerts, Quality Product Alerts, Product Recall and Quality Defect Notification processes. Our mission is to develop and maintain mature End to End Global Quality Risk and...

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 looking for the best talent in Trade Compliance. Key Responsibilities Support major Global Trade Operation projects through data analysis (i.e. Operating Company initiatives, reports, databases, etc.) Provide recommendations to project teams bases on analysis Maintain databases used by Global Trade Operations and Global Trade Operation suppliers for various transactions Updates to metrics while working to improve and enhance processes with all available...

We are searching for the best talent for Manager, Regulatory Advertising & Promotion to join our Health Care Compliance organization. This position can be based in Horsham, PA, Titusville, NJ or New Brunswick, NJ. Please note that this position is not eligible for relocation and that onsite presence is required three days a week. Key Responsibilities Provide direction and oversight of regulatory advertising & promotion compliance activities for assigned products. Conduct regulatory promotional labeling and marketing compliance reviews in the R&D and commercial arenas to help ensure that activities and communications are consistent with product labeling, are adequately supported and...

Johnson & Johnson is currently recruiting for Quality Systems Document Management Associates! There are three current openings for this role and they will be located in Raritan, NJ. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at The Quality Systems Document Management Associate will provide support for document...

Johnson and Johnson is recruiting a Senior Manager, ATSC External Quality located in Gaitherburg, Maryland. Key Responsibilities Provide quality leadership and technical support to ensure effective and compliant execution of quality systems at external manufacturing sites working in the CART space Manage quality oversight in the selection, qualification, and ongoing monitoring of external partners Provide oversight for tech transfer and new product introduction activities in the CART space; lead PAI readiness activities, and support associated health authority filings and approvals Daily management and coordination of the EQ work team supporting the EM as needed Lead...

Purpose AbbVie Bioresearch Center in Worcester, MA is seeking an Engineer with significant experience in the validation of biologics equipment to join the Validation Engineering Group. The selected candidate will be responsible for commissioning and qualification activities associated with capital projects involving the installation and/or renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA/GMP regulated environment. The engineer will work in a multi-disciplinary team environment. Responsibilities Prepare validation test protocols, set validation strategy, perform/coordinate validation testing for capital projects of different complexity in concert with all stakeholders, and analyze/assemble test results to create summary reports as required Execute...

Beam is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Promotion to progress advanced genetic medicines in a fast paced and dynamic biotech environment. The person will be responsible for leading all regulatory labeling activities for Beam’s hematology programs including creation of documents (e.g. CDS, USPI) and processes. Responsibilities Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles. Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications. Create regulatory labeling processes and associated SOPs,...

Position Senior Manager Validation Engineering Location Devens, MA Key Responsibilities Lead functions within the Validation Engineering group responsible for the qualification lifecycle of facility, utility and processing equipment systems. Leads functions responsible for installation, operational and performance qualification (I/O/PQ) of systems arising from projects and change controls. Leads the site Periodic Assessment and Requalification program by establishing procedures aligned with BMS directives and industry guidance. Ensures execution of program to predefined schedule. Establish validation project plans commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination...

Position Senior Manager Cleaning Validation Location Devens, MA Key Responsibilities Provide strategic oversight and management of the cleaning validation program, ensuring alignment with regulatory requirements and industry best practices. Develop, write, and execute cleaning validation protocols, reports, and risk assessments. Establish acceptance criteria and sampling plans for cleaning verification and validation. Delegate tasks and coordinate the execution of cleaning studies, ensuring timely and effective completion. Optimize and update cleaning validation strategies and procedures to reflect current industry standards and regulatory expectations. Perform swab and rinse sampling, cleanability, degradation and sampling recovery studies reviewing analytical results against acceptance limits. Support...

Patient Safety is seeking a dynamic and experienced individual to join the Patient Safety Strategic Operations team as an Associate Director, Patient Safety Medical Device Safety responsible for supporting activities to ensure ongoing safety oversight of Gilead’s medical devices and combination products throughout the product lifecycle. These activities include but are not limited to ensuring compliant global processes for vigilance/safety reporting, post-market surveillance system, trending of device complaints, risk management, and analysis of safety data sets covering Gilead medical device and combination product portfolio. This role will help drive strategies and ensure operational excellence through successful business partner collaboration. The...

This role is o nsite 5 days at our Grand Rapid, MI manufacturing site. Responsibilities may include the following and other duties may be assigned. Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and...

About the Role Assist in the development of lab test methods on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Shire manufacturing facilities. How you will Contribute Assist in the development of lab test methods on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Shire manufacturing facilities. Work under minimum supervision. Assist with the installation and validation of sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced assays requiring precise analytical skills and understanding of microbiology and chemistry principles. Complete all testing,...

Objective / Purpose The Head of Research Quality holds the highest leadership role within the Research Quality organization and serves as a key member of the R&D Quality leadership team. This executive is fully accountable for defining and executing the global strategic vision for Research Quality, overseeing a global team of experienced subject-matter experts dedicated to ensuring integrity, compliance, and ethical excellence in non-clinical research activities, studies, and processes supporting Takeda’s R&D pipeline. Through strategic leadership, impactful stakeholder engagement, and championing an enterprise-wide quality culture, the Head of Research Quality drives organizational success and reinforces Takeda’s commitment to industry-leading standards....

Job Title Staff Engineer, Customer Quality Analytics This position works out of our Sylmar, CA or Sunnyvale, 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. WHAT YOU'LL DO The Staff Engineer, Customer Quality Analytics is responsible for understanding and representing the customer experience for Cardiac Rhythm Management (CRM) products. The successful candidate will be a technically knowledgeable, customer facing experienced engineering or medical personnel who operates using facts and data and has...

Medical Director, AI Innovation and Validation, Global Patient Safety Location New York City, NY At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week . Our head office is purposely designed with collaboration in mind, providing...

Senior Development Quality Manager This position works out of our Menlo Park, CA location in the Structural Heart division. Structural Heart Business Mission Why We Exist! Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. We are seeking a passionate Senior Development Quality Manager 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...

Summary The primary objective of this position is to ensure the Bristol Myers Squibb US compliance with state regulations by preparing, submitting, and managing applications for various state licenses and permits. Must have the ability to stay update to date on regulatory changes, coordinate with state boards, keep and maintain organized records, and collaborate with internal departments such as legal, corporate governance and operations to support business expansion and ensure operational readiness. In this role, you will work collaboratively across functions and provide leadership and direction to multi-disciplinary teams including but not limited to third parties vendors engaged by BMS,...

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...

Purpose The primary responsibility for the Quality Validation Specialis t is the Quality oversight and overall approval of validation and engineering change management activities. The Validation engineering department, will support the implementation of the Validation quality program, and will be expected to independently manage 5+ key projects simultaneously. Responsibilities Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility Executes tasks as required to implement the Validation Master Plan and...

Purpose Supports AbbVie’s global quality assurance function, suppliers and manufacturing sites for medical devices and combination products by providing in-house support to ensure product meets customer and regulatory requirements. This position supports the analysis and data collection for product or quality system issues intended to support continuous improvement. This position will also be involved in the support of regulatory inspections for medical devices and combination products. The employee must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources,...

Medtronic’s Cranial and Spinal Technologies (CST) Operating Unit is committed to transforming patient care through groundbreaking innovations in neurosurgery and spinal procedures. Our comprehensive portfolio includes spinal implants, robotics-assisted surgical solutions like the Mazor™ Robotic Guidance System, StealthStation™ surgical navigation, and biologics for bone healing, all designed to enhance surgical precision, efficiency, and patient outcomes. Beyond technology, we support surgeons through education, training, and clinical research, ensuring they have the tools and knowledge to achieve the best possible results. By continuously driving innovation and collaboration, Medtronic is redefining cranial and spinal care, improving lives worldwide. Join a diverse team of...

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. This role is 100% onsite at our Milwaukee, WI manufacturing site. Responsibilities may include the following and other duties may be assigned. Ensure that suppliers deliver quality parts, materials, and services. Lead cross-functional teams of engineers...

This position works out of our Alameda, CA office and is responsible for ensuring that Abbott and Lingo product software and computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements. This is an individual contributor position which may have responsibilities to monitor and direct the work of contractors/temporaries. What You’ll Work On Participates as a member of the project team for Lingo products that incorporate software/firmware into their system. Completes SWQA tasks in accordance with current Quality System Requirements. Works independently with objectives given by SWQA Manager....

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. This position is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance and/or Drug Product Vaccine manufacturing. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across...

Your skills could be critical in helping our teams accelerate progress. The Director, Global Regulatory Affairs – Global Labeling Strategy is responsible for leading the development and implementation of global labeling strategy for assigned products, including those in early and late-stage development, life cycle management (LCM), and marketed portfolios. This role provides functional leadership and oversight for one or more therapeutic areas and may supervise or mentor Global Labeling Strategists. The Director plays an active role in shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including guidance on Phase 2 and Phase 3...

Your skills could be critical in helping our teams accelerate progress. As GRA CMC Lead within our GRA CMC & GRA Device Organization, you’ll drive global regulatory strategies for pharmaceutical and vaccine products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of drug approvals through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the opportunity to drive regulatory strategy for pharmaceutical products and vaccines across their lifecycle. Working at the intersection of science and compliance, you'll develop...

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 Sr. Design Quality Engineer role to be located at Danvers, MA. The ideal candidate for the Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a role in product risk management, cybersecurity, change controls, and design controls. This engineer should excel in an environment that embraces...

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. Quality Engineer I is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What You’ll Work On Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and...

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. Quality Engineer I is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What You’ll Work On Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and...

ABIOMED is redefining team-driven success while reshaping heart recovery. Here, new ideas are welcomed and encouraged, learning is constant, and our dynamic setting enables positive people to do profoundly important work. 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...

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...

Purpose The Quality Systems Director serves as a leading subject matter expert and project manager for the continuous improvement of the AbbVie Quality System. As such, the QS Director must maintain current subject matter expertise in the latest developments in global pharmaceutical quality systems. In addition, the QS Director must be able to integrate and facilitate the formation of the Device Quality System both as a part of the AbbVie QS and as individual plant quality systems. The QS Director also serves as the Operations Coordinator of the Regulatory Intelligence Process. As such, they are responsible for the capture, dissemination...

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 Core Lab team is looking for an Operations Quality Engineer out of our Irving, TX office. They will be responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. Heavy focus on the operation side, mostly with quality inspections. Responsibilities Responsible for...

This position works out of our Santa Clara, CA 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 Development Quality Engineer II, you’ll a ssure new or modified products conform to requirements and establish compliance with the quality system. This position is 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. This position will support the new product...

As a Senior Quality Systems - CAPA Specialist, you will have responsibility for coordinating the Medtronic Energy and Component Center (MECC) Quality CAPA Portfolio. Coordination includes partnering with those team members to define, investigate, execute, and resolve product and quality systems issues to ensure they don’t recur. By supporting the Quality Function, you will provide critical compliance guidance and direction for CAPA impacting battery and component nonconformances, complaints, regulatory reporting, PHO, and FCA. Responsibilities will include additional Quality Management System project work as needed. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in...

The Senior Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities that are necessary in obtaining and/or maintaining regulatory clearance/certification within the United States and Europe for powered surgical devices. This position is largely responsible for sustaining activities and ad prom review. Sustaining activities include, but are not limited to, review of all change control activities related to assigned product family and performing regulatory assessments. Additionally, this role will be responsible for the LTF, 510(k)s, technical documentation updates, and EU change notices that result from the regulatory assessment. This role is also responsible for labeling and ad...

Medtronic has declared its bold ambition to become the global healthcare technology leader. By doing so, we seek to reach more patients in more meaningful ways, more quickly. Are you looking to develop capabilities and competencies in Operational Excellence (OpEx) for a leader in the Medical Technology industry? As Sr. Director, Operational Excellence/Quality Lead, you will play a key role in enabling the enterprise evolution of the Medtronic Performance System (MPS). In this role, you will have the ability to own operational excellence processes, people, and results in driving change across our global Quality and Development organization. You will collaborate...

Responsible for Quality oversight of analytical methods and specifications used to test and release Acadia’s products. This position assists in establishing commercial analytical methods to support manufacturing, release, and stability testing conducted at Acadia's drug substance (DS) and drug product (DP) Contract Service Providers (CSPs). Responsible for the Quality oversight of CSPs performing GMP analytical testing and review of analytical method validations/transfers between laboratories. This position will be responsible for reviewing the quality of release testing and stability data for DS and DP. Coordinate efforts with CSPs to report and trend analytical test results in a timely manner. This position...

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...

About the role As the Director Quality Assurance, you will be responsible for identifying, planning, and implementing quality initiatives across the organization. You will aim to improve productivity, utilization, and technology intervention, contributing to the organization's overall success. As a leader of a sizable (functional) area, serving as the primary internal and external contact for contracts and operations, your responsibilities include conducting high-level briefings and technical meetings, interacting with managers of equivalent status, and crafting corporate and organizational policies. You will provide strategic direction and oversight to managers across various functional areas, prioritizing the successful execution of major initiatives and...

Johnson & Johnson Neurovascular is recruiting for a Staff Design Quality Engineer, Life Cycle Management in Raynham, Massachusetts. 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 position provides quality technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs. The use of engineering and supply chain knowledge to assist in the execution of cross-functional projects in support of the...

As a QA & Compliance Intern at AbbVie, you will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical and medical device industry. You will support the R&D Quality Assurance & Compliance team, which develops, implements, and continually improves the AbbVie Quality System in R&D. The team ensures that clinical research and operations consistently meet regulatory requirements, internal standards, and ethical guidelines, thereby protecting patient safety, upholding data integrity, and supporting the reliable development and approval of products. Key Responsibilities Independently review complex clinical trial and...

About the Role This application is for a 6-month student role from January - June 2026. Resume review begins in October 2025. Biogen’s Decision & Quality Analytics Innovation (DQAI) team is part of the Research Development & Medical (RDM) organization. The vision of the DQAI team is to drive data-driven insights from trusted data, and our team mission is to maximize the quality, efficiency and application of analytics across RDM Portfolio and Quality Management Systems through improved data and metrics management, optimization opportunities, identification of compliance risk, and enhanced business analytics application. Specifically, the DQAI team has four major focus...

We are looking for a detailed, organized, customer-focused Grants & Donations Associate Compliance Specialist for Medtronic’s Cardiac Rhythm Management (CRM) business, the largest business within our Cardiac & Vascular Group (CVG). 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 and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities may include the following and other duties may be...

The Senior Design Quality – Electronic Engineer position, is one of development, improvement and innovation. If you pride yourself on your problem-solving skills and a meticulous attention to detail this may be the role for you. You will be tasked to provide quality engineering support in the design and development of electronic medical device products. Facilitate the application of Design Controls, Risk Management and Change Control processes in the evaluation and implementation of changes to released products. Responsibilities may include the following and other duties may be assigned. Previous experience in Electronic PCB design and development. Preferably with a formal...

About the role The Supplier Quality Management Senior Analyst is responsible for identifying, coaching, and managing suppliers to ensure they meet Takeda’s quality standards and policies. This role supports strong supplier performance and compliance, contributing to Takeda’s mission of better health and a brighter future. As a Senior Analyst, you’ll address moderately scoped challenges using sound judgment within defined procedures and policies. You’ll apply industry practices and general knowledge to keep projects on track, primarily collaborating internally with subordinates and supervisors, with minimal external interaction. How you will contribute Execute global supplier and material/product management activities for locally assigned suppliers,...

About Cardiovascular Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for...

Sr. Quality Engineer Risk Management As a Sr. Quality Engineer – Risk Management , you will serve as a Subject Matter Expert (SME ) responsible for developing and maintaining quality systems, subsystems, and key processes related to Risk Management. You will also provide quality engineering support across new product development, manufacturing, and/or system and service support. What You’ll Work On Implement and maintain the effectiveness of the Risk Management Quality System element Interpret regulations and requirements to lead, coach, and mentor teams on Risk Management Serve as SME for domestic and international sites and affiliates regarding Risk Management Estimate...

As a QA & Compliance Intern at AbbVie, you will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical and medical device industry. You will support the R&D Quality Assurance & Compliance team, which develops, implements, and continually improves the AbbVie Quality System in R&D. The team ensures that clinical research and operations consistently meet regulatory requirements, internal standards, and ethical guidelines, thereby protecting patient safety, upholding data integrity, and supporting the reliable development and approval of products. Key Responsibilities Supporting the Quality Assurance & Compliance...

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

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. Responsibilities The Sr. Manager Logistics Quality will report to the Associate...

responsibility for providing risk management expertise and best practices for released products and post-market activities within the Advanced Surgical Technologies organization. This includes evaluating product issues to ensure patient, user and security risk are assessed, and acting as the Quality Engineer Risk Management file owner for the CSI capital hardware and disposable products. Responsibilities may include the following and other duties may be assigned. · Serves as Subject Matter Expert for Risk Management across the Post-Market space for their assigned product families · Accountable for and owns the Risk Management Files for assigned product families · Maintains Risk Management Files...

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...

ROLE SUMMARY Our Global Cybersecurity Governance, Risk, and Compliance (GRC) team plays a critical role in safeguarding Pfizer’s digital assets, ensuring regulatory compliance, and protecting sensitive data across all business functions. As part of our strategic commitment to strengthening our cybersecurity posture, we are enhancing and modernizing our GRC program to address enterprise-wide risks across applications, data, vendors, and critical operations. We are seeking an experienced individual of Cybersecurity Governance, Risk, and Compliance to lead this transformation. The ideal candidate will have deep expertise in enterprise cyber risk management, regulatory compliance, audit readiness, and oversight of GRC technologies. This leader...

Job Responsibilities Independently and proactively initiate and drive the planning, execution, and completion of change management projects Develop and implement strategies to mitigate risks within the change management process and change control system. Facilitate and present at cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS and regulatory expectations. Responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals. Develop, deliver, and improve the change management program for various levels of the organization, while also ensuring training...

About Cardiovascular Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for...

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 Engineering Intern to be in Palm Beach Gardens, FL. Internship typical term is 10-12 weeks May to August, 2026 Full time requirement (40 hours per week) Purpose Our rapidly growing Velys Robotics and Power Tools Operation is in need of a Quality Engineering Intern who provides overall quality assurance support of on-site manufacturing...

As an RDQA GQC Intern at AbbVie, you will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical industry. You will support the RDQA GQC organization, working collaboratively and strategically with colleagues across R&D. The role of RDQA is to ensure the highest standards of quality and compliance in all we do. We are committed to safeguarding patient safety and upholding ethical conduct, serving as a cornerstone for trust and integrity. By continuously improving, and collaborating with partners, we promote a quality-focused culture that supports innovation...

At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as a Sr. Manufacturing Quality Engineer to support our capital products line. In this role, you will have the unique opportunity to contribute to manufacturing of life-saving medical devices. As part of our "Patients First!" culture, you will play a crucial role in ensuring the highest quality standards are met to save lives and recover hearts. Responsibilities and Duties Provide quality engineering support in the development and manufacturing of new and existing capital products Ensure compliance of manufacturing processes...

Purpose This position reports into the Office of Ethics and Compliance (OEC) function through supporting the execution of an effective compliance program for the PR Affiliate. Responsible for the Affiliate execution of the annual monitoring plan by conducting internal monitoring and other annual risk assessments of compliance related activities, including training. The purpose of this role is to aid in the design and execution of comprehensive annual monitoring plans to ensure that each functional area within the Affiliate operates within the policies, procedures and regulations set forth by the Company as well as applicable local, state and federal laws. This...

The Opportunity We are seeking a Quality professional to join our GCP Quality Assurance function at Relay Therapeutics (Relay Tx). Under the direction of the Senior Director, you will partner with your QA, QMS, and Clinical Development colleagues in supporting our clinical trial quality and strengthening of our clinical QMS as our pipeline evolves. At Relay Tx, we take Quality seriously, but we don’t take ourselves too seriously. You’ll have fun in our collaborative and energetic environment where you’ll face new challenges every day. Your Role You will track and follow up on GCP/GCLP/GVP quality issues/events...

The Executive Director, Regulatory Operations is responsible for leading the teams of publishing, submission management, regulatory information management, compliance and the regulatory management office. This role will be accountable for creating a high quality organization that utilizes the best in technology, process and project management to deliver global submissions in a highly effective and efficient way. This role will drive the strategic framework for how GRA operates as a group including centralized oversight of functional strategic objectives. Key Duties and Responsibilities Leads the Submissions Management & Publishing groups, and the delivery of quality global dossiers to HAs utilizing effective planning...

Innovative Medicine, Regulatory Compliance, Large Molecule/Advanced Therapies Leader 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 pharmaceutical, and medical technologies professional markets. J&J employs approximately 126,500 people worldwide, deployed in more than 250 operating companies in 60 countries. Johnson & Johnson, Innovative Medicine a leading pharmaceutical company under Johnson & Johnson, has established a strong presence in the field of biologics and large molecule therapies, particularly through its innovative advanced therapies portfolio. The company's contributions have significantly advanced...

That’s what makes us Roche! In Pharma Development Quality (PDQ) we strive to demonstrate confidence in the integrity of our data and our 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 (GVP, GCP and Medical Device). The Opportunity The Quality Assurance Affiliate Head leads the strategy, planning, and execution of quality assurance for affiliates while managing an expert team of Quality Leads to deliver Affiliate Quality Conclusions on the areas that are Critical to...

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 career at Medtronic is like no other. We’re purposeful, committed, and driven by our Mission; alleviate pain, restore health, and extend life. Peripheral Vascular Health is dedicated to the treatment of peripheral arterial and venous diseases through providing a comprehensive suite of products and therapies. Our goal is to help healthcare professionals save limbs, reduce pain, and treat disease — so their patients can get back to enjoying what they love. The Plymouth Nathan Lane site is looking for a Quality Technician that will be responsible for helping to support production and associated activities. The ideal candidate will be...

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. Manufacturing Operations is responsible for supporting large scale mammalian cell culture and multi-stage large scale chromatography manufacturing operations as part of a 24/7 large-scale therapeutic protein or vaccine manufacturing facility. Operation’s main functions are leading deviation investigations and managing CAPA Implementation, partnering with direct manufacturing staff for enhancing and improving...

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...

Position We are seeking a Senior Manager, Regulatory Affairs, to join our dynamic team. In this role, you will play a pivotal part in ensuring that our biotechnological advancements comply with all relevant regulations and standards. You will work closely with cross-functional teams to guide product development and market entry strategies while maintaining compliance and transparency with regulatory agencies. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support...

Regeneron is seeking a Director, Regulatory Labeling Operations to join our team! In this role, a typical day might include The Director, Regulatory Labeling Operations will be responsible for providing oversight to Regulatory Labeling Operations in the development, revision, and approval of packaging component artworks for marketed products as well as products in full development. Oversees the preparation and delivery of submission-ready labeling documents. Manages interface with Manufacturing/Supply Chain, Regulatory Operations, and various labeling vendors (e.g., SPL, translations, QC tool, etc.). Leads or supports labeling content and/or artwork system development and implementation. Supports the creation or revision of labeling SOPs...

Are you a highly skilled professional, interested in Quality Excellence, driven by a passion for innovation and a desire to make a tangible impact? We have a thrilling opportunity for a Quality Excellence Lead to join our Global Quality team, shaping quality strategies, managing critical to quality risks and business continuity, and delivering insights that drive a thriving future for our Quality and Product Development organization. The Opportunity That’s what makes us Roche! Our commitment to quality in Pharma Development is unwavering. We deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators,...

The Principal Compliance Audit Specialist – Software and Product Cybersecurity position focuses on auditing regulated medical device software, product cybersecurity, and risk management. We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers. Responsibilities may include the following and other duties may be assigned. Must have experience, subject matter expertise (SME), and technical knowledge working with regulated medical device software and product cybersecurity requirements. Remain informed on Regulatory requirements for...

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 employees embrace Operational Excellence in everything we do, to achieve...

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...

Associate Director - Analytics, Global Regulatory Affairs Role Purpose Strategic and operational oversight of custom analytics deliveries from Global Regulatory Affairs involving Business Intelligence solutions and related semantic layer dependencies. Primary Accountabilities, Duties and Responsibilities Responsible for strategic and operational oversight of the semantic layer and custom analytics capabilities in alignment with the Global Regulatory Analytics lead. Working with primary Business Stakeholders to help strategically align, shape and optimize requests to ensure organizational and pre-existing solution alignment. Support in-flight resources to support understanding and documenting data & insight requirements\ technical specification needs. Monitor, facilitate, and report around key initiatives /...

We are hiring a Quality Compliance Director to join the West Point Quality Assurance Leadership Team. The West Point Quality organization ensures our products are manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our West Point campus, internal manufacturing facilities, and suppliers; our team creates a global manufacturing network dedicated to deliver a compliant, reliable supply to customers and Patients on time, every time, across the globe. The Quality Compliance Director will drive FDA and global inspection readiness, oversee site internal audits and Health Authority reporting,...

Johnson and Johnson is recruiting for a Quality Management Platform Analyst, located in Wilson, NC. We need a forward-thinking, data analyst, to evaluate, road map and construct an area within our workspace in Kneat to house our method verification and transfer execution worksheets protocols and reports. 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...

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...

Job Title Sr. Engineer Supplier Quality This position works out of our Temecula, CA location in the AVD Vascular division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. We are seeking a high caliber Senior Engineer Supplier Quality d rives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You’ll Work On Assess potential new suppliers for technical, quality and manufacturing...

This position works out of our Westfield, IN location in the Structural Heart Clinical Affairs 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 Quality Engineering Technician, you’ll provide technical assistance to Engineering to support manufacturing efforts by implementing corrective and preventative actions. You will assist Engineers in developing methods and procedures to control or improve manufacturing processes. This position is on a Monday - Friday, 6 AM - 230 PM schedule. What You’ll Work On Responsible...

Job Title Quality Engineer II This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. The Quality Engineer II is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What You’ll Work On Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal...

Careers that Change Lives Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. Agility and responsiveness are critical to our success with remote monitoring, wearables, robotics, AR/VR, telemedicine, and more. Experience what it’s like to work at a company with an exciting product pipeline entire of patented inventions driving innovation in the healthcare space. The Ear, Nose, and Throat Operating Unit is a global leader and trusted partner for innovative ENT solutions that improve patient access, outcomes, and customer satisfaction. We partner with the ENT community to understand the needs of customers...

This application is for a 6-month student role from January - June 2026. Resume review begins in October 2025. Biogen’s Decision & Quality Analytics Innovation (DQAI) team is part of the Research Development & Medical (RDM) organization. The vision of the DQAI team is to drive data-driven insights from trusted data, and our team mission is to maximize the quality, efficiency and application of analytics across RDM Portfolio and Quality Management Systems through improved data and metrics management, optimization opportunities, identification of compliance risk, and enhanced business analytics application. Specifically, the DQAI team has four major focus areas Data Management...

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 This position is responsible for assisting in the conduct of clinical trials by providing support to the Clinical Quality team. This position will work cross-functionally with all members of the Clinical Affairs team to successfully execute the clinical...

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and...

The Executive Medical Director, Patient Safety/Head Medical Safety and Risk Management will oversee all safety and benefit-risk related activities of the GPS Physician (Disease-area Safety Heads, DST Chairs) and the Aggregate Report Risk Management (ARRM) Groups within the Vertex Global Patient Safety (GPS) Department. As a member of the GPS Senior Leadership Team, the role will contribute to ensuring consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Overseeing the GPS DASH/DST teams across therapeutic areas, the role will ensure consistent conduct and timely execution of Benefit-Risk activities by GPS DASH/DST...

We have an immediate opportunity for a Senior Auditor, Global Compliance Audit in our Willis Tower, Chicago, IL location. Embark on a rotational career path within Abbott’s Audit team. Position leads to potential career opportunities in any of Abbott’s four global businesses as well as Corporate roles. This role has primary responsibility for executing the following duties Identify opportunities for improvements in sales & marketing practices against Corporate policies, local procedures, industry standards and laws/regulations. Analyze data and document findings and recommendations in audit reports. Effectively communicate, present professionally, and collaborate with the highest level of Corporate and Divisional management,...

The Director, Regulatory Affairs Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the Oncology 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 of the product. Demonstrates excellent...

The Senior Manager, RA Global Regulatory Strategy US and 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. Assures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements. Responsibilities Responsible for a product(s) or products...

This position works out of our Abbott Park IL (preferred) or any Abbott's manufacturing location. What You’ll Work On Our location in Lake Bluff, IL currently has an opportunity for a Program Quality Manager in Complaints, Vigilance and Product Actions. The function of the Quality Program Manager is to provide corporate-level leadership and guidance for Quality Systems matters related to complaint management, medical device reporting/vigilance and product actions (corrections and removals), as well as supporting other Abbott Quality System elements as it relates to post market surveillance. This includes but is not limited to providing global support to Abbott Businesses/Divisions,...

Customs & Trade Compliance Analyst This position works out of our Columbus, Ohio Easton Square location in the Nutrition Division . Primary Function/Primary Goals/Objectives Provide technical and analytical support for customs and trade compliance matters at the site/division level, ensuring compliance with all relevant customs regulations and trade laws and regulations, including 19CFR, 15CFR, FDA, USDA, and other US regulatory agency requirements. Operates with general direction and supervision from the Manager. Incumbent is accountable for compliant importation of goods and services (including machinery), as well as proper classification and valuation. Failure to comply is a violation of law and...

This position works out of our Abbott Park IL (preferred) or any Abbott's manufacturing location. What You’ll Work On Our location in Lake Bluff, IL currently has an opportunity for a Program Quality Manager in Complaints, Vigilance and Product Actions. The function of the Quality Program Manager is to provide corporate-level leadership and guidance for Quality Systems matters related to complaint management, medical device reporting/vigilance and product actions (corrections and removals), as well as supporting other Abbott Quality System elements as it relates to post market surveillance. This includes but is not limited to providing global support to Abbott Businesses/Divisions,...

About the Site Located just outside Atlanta, Takeda’s state-of-the-art manufacturing facility in Covington is one of the largest biotech production sites in the world. As a pivotal part of Takeda’s global manufacturing network, the Covington site plays a key strategic role in supplying high-quality plasma-derived therapies to patients worldwide. Equipped with advanced technology and modern processes, the facility supports ongoing innovation, helping to drive Takeda’s growth and mission to deliver life-changing medicines. About the role As our Quality Control Leader, you will play a pivotal role in guiding and supporting all quality control activities at our site, encompassing analytical chemistry,...

About This Role The Sr Manager, Supply Chain Quality Lead is responsible for providing oversight and support to all distribution quality related activities within the USA. They are responsible for developing quality awareness and inclusion in all processes and facilitate or mentor processes required for the establishment of effective quality management systems. The Sr Manager will liaise with all functions within our Pharma Operations & Technology division and outside to assure seamless processes and patient access to medicines. This person will have QA oversight of logistics of products’ distribution worldwide and management of deviations, CAPAs, Change Controls, audits and serialization....