Quality & Regulatory Jobs in Pharma & Biotech

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

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

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

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

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

Understands, implements, and maintains a safe work environment and good manufacturing practices with respect to procedural requirements and laboratory records and requirements. Maintains training certificates as needed for assigned job tasks. Performs product complaint documentation, investigation, and review of all non-medical complaint content. Analyze and test routine to medium complexity products, and evaluate results. Performs test methods as written to support product complaint investigation activities with minimal error. Interprets experimental data for conformance with product and material specifications. Initiates appropriate exception documents in accordance with procedural requirements. Accepts responsibility for acquiring knowledge and experience to support continual personal development. Can...

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

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

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

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

Experienced Analyst- Data Quality & Automation Supply Chain Data Management | Johnson & Johnson Location New Jersey Department Supply Chain — Data Quality Hiring Manager Kriti Bhardwaj, Director, Digital Strategy and Operations Employment Type Full-time About the Role Johnson & Johnson is recruiting for an Experienced Analyst – Data Quality and Automation to join our Data Team. The position is based out of US/LATAM. 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,...

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

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

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

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

As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation. MAIN RESPONSIBILITIES Strategic Planning Assist in SOP development and review. Provide regulatory input to product...

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

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

The GMP Operational Quality Senior Specialist is recognized as a subject matter expert in the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities, and supports new/existing project initiatives. The role works with a high degree of independence and coordinates GMP activities to provide QA Analytical support for commercial product stability programs and executes routine tasks and activities in support of QA Analytical function. Key Duties and Responsibilities Provides QA review of the GMP data in support of commercial product stability as required. Has a good understanding of stability...

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

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

About the role Perform Quality activities associated with cGMP biologics, intermediate, and/or drug substance manufactured at the Takeda Brooklyn Park Site. Focused primarily on providing support and guidance on complex and non-routine quality-related issues How you will contribute Follow all established, written procedures. Drive the assessment and implementation of global and local policies, guidance documents, standards, and procedures governing cGMP work performed at the site. Performs documentation review thoroughly, with a high attention to detail using extensive working knowledge of quality concepts and internal procedures and controls. Analyzes and interprets projects, studies, or investigations to determine next steps. Makes decisions...

About the Role Conducts and performs a wide range of biological, chemical, or physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods, and may include environmental monitoring programs. You may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations. 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 Takeda manufacturing facilities. Work under minimum supervision. Assist with the installation and validation of sophisticated laboratory...

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

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

We anticipate the application window for this opening will close on - 27 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life As a Quality Systems Specialist, you...

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

Associate Director Regulatory Affairs, Oncology At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionizing the way we do R&D. We’re uniting science, technology and...

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

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

Provides independent evaluation of materials, components, and products per specific instructions, and work process within the quality system. Quality and production support resource to ensure compliance with policies and procedures within an atmosphere of error prevention and continual improvement. What You’ll Do Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Review material, equipment, and systems quality through examination, inspection, measurement, or testing of raw materials, components, sub assembly, final assembly, packaging, labeling and documentation. Contributes to validation testing as defined on validation protocols with engineering guidance. Ensures that all evidence documentation complies with governing procedures. Audits and...

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

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

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

Key Responsibilities The position holder is responsible and accountable for the tasks given below (non-exhaustive list) Quality oversight of the activities and services provided by suppliers Serves as a single point of QA contact for indirect suppliers supporting CT manufacturing sites. Assists with supplier qualification activities of new and current suppliers in support of Clinical and Commercial Manufacturing activities. Initiate and Manage Supplier Quality risk assessments. Create / negotiate and maintain Supplier Quality Agreements. Work closely with the suppliers and involve SMEs to ensure proper and timely resolution of SCARs, Deviations, Complaint investigations and CAPAs; ensures properly documented per BMS...

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

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

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

Sr Associate Supply Chain Compliance What you will do In this vital role you will serve as a key compliance partner within the US and LACAN Supply Chain, safeguarding product quality and patient trust through the effective implementation of GDP requirements, quality systems, and regulatory standards. Lead critical quality processes, identify and mitigate risks, and drive operational excellence across the distribution network. Specific responsibilities include but are not limited to Own and manage temperature assessment records. Own and manage minor and major deviation records and lead root cause analysis sessions. Own and manage CAPA and CAPA EV records, ensuring...

We anticipate the application window for this opening will close on - 27 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we bring bold ideas forward...

We anticipate the application window for this opening will close on - 21 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life In general, the following responsibilities apply for...

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

Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as 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 are searching for the best talent for Quality Engineer to join our DePuy Synthes Quality organization located in Palm Beach Gardens, FL. The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. Our rapidly growing Velys Enabling Tech Operation is in need of a Quality Engineer who provides overall quality assurance leadership...

Johnson & Johnson is currently recruiting for Senior Quality Systems Analyst–US Last Mile! This position can be performed remotely within United States. Remote work may be considered on a case-by-case basis and if approved by the business. The Sr Quality Systems Analyst executes quality system activities supporting US DePuy Synthes Commercial Quality (CQ), distribution sites, regional functions, and Last Mile field inventory managers. The role is responsible for supporting quality system data review, metrics reporting, document management, training process execution, and compliance activities that help maintain an effective Quality Management System for commercial activities in the US Key responsibilities...

Johnson & Johnson Vision is recruiting for a Quality Control Technician IV , located in Jacksonville, Florida. 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 Key Responsibilities Applies functional knowledge of Quality Control requirements to execute organizational objectives. Supports planning and delegation of administrative tasks and support, including data maintenance and scheduling. Develops partnerships across the organization to ensure flawless customer support. Updates quality policies and procedures based on new...

JOB SUMMARY The Senior Director Regulatory Compliance provides key strategic insight, direction, and oversight for all areas of Regulatory Compliance within Abiomed, Shockwave, V-wave (MedTech) companies worldwide. Partners with leaders in R&D, Regulatory Affairs, Quality, Legal, Supply Chain, Clinical and Johnson & Johnson Regulatory Compliance to manage risk and ensure a strong regulatory compliance profile. Assures quality and compliance risk is identified and mitigated. Responsible for the Inspection Readiness, Inspection Management, and the Internal Audit program for the assigned Sites. Supports the development and execution of remediation programs as needed. Supports the integration of new acquisitions, due diligence, New Product...

We are searching for the best talent for Director, Regulatory Intelligence Enforcement to join our Enterprise Regulatory Compliance organization located in New Brunswick, NJ; Raritan, NJ; Horsham, PA; or Washington, DC. The Director, Regulatory Intelligence Enforcement is responsible for identifying and translating global health authority enforcement signals into actionable intelligence that strengthens inspection readiness and supports sustained GMP compliance improvement across the enterprise. The role monitors inspection outcomes, enforcement actions, and emerging inspectorate focus areas to provide forward-looking analysis that informs site readiness programs, internal audit planning, and executive decision-making. This leader produces periodic enforcement trend reports and develops a...

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

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

Validation Engineer – Casa Grande, AZ Nutrition Plant As the Validation Engineer, you will ensure that change control and validation activities are executed in a timely manner while following all Abbott Nutrition Policies and Standards. This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get...

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

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

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

About the Role The Head of Ethics & Compliance Operations & Enablement serves as the chief operating leader for Takeda's Ethics & Compliance function. As a member of the Global Ethics & Compliance Leadership Team, this leader is responsible for the governance, capabilities, technology, operational excellence, and infrastructure that enable a modern, high-performing Ethics & Compliance organization. How you will contribute Partner with Ethics & Compliance leaders and enterprise stakeholders to strengthen the effectiveness, consistency, and scalability of the global Ethics & Compliance program. Advise leadership on program governance, operational priorities, resource planning, and organizational effectiveness. Build trusted partnerships across...

About the role The Head of Ethics & Compliance, Global Supply Chain & Quality (GSQ) and Plasma-Derived Therapies (PDT), serves as the senior Ethics & Compliance leader and strategic advisor to both organizations. As a member of the Global Ethics & Compliance Leadership Team, this leader partners closely with executive leadership to integrate ethics and compliance into product development, manufacturing, quality, supply chain, and plasma operations while supporting Takeda's commitment to operational integrity, product quality, patient safety, and innovation. How you will contribute Serve as the primary Ethics & Compliance advisor to GSQ and PDT leadership, providing practical, risk-based guidance...

About the role The Head of Compliance Risk & Assurance serves as the independent assurance leader for Takeda's Ethics & Compliance function. As a member of the Global Ethics & Compliance Leadership Team, this leader provides objective, data-driven insight into enterprise compliance risks and the effectiveness of the Ethics & Compliance program. Through independent assessment, modern assurance practices, and forward-looking risk intelligence, this role strengthens governance, informs executive decision-making, and drives continuous improvement across the enterprise. How you will contribute Serve as a trusted advisor to Ethics & Compliance leadership and enterprise stakeholders by providing objective insight into compliance risks,...

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

We anticipate the application window for this opening will close on - 24 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Medtronic is seeking a highly skilled...

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

We anticipate the application window for this opening will close on - 25 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life This is an add position with a...

We anticipate the application window for this opening will close on - 21 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life A DAY IN THE LIFE The Senior...

An engineering professional that works with project engineers, stakeholders, and other project team members to complete tasks associated with commissioning and qualification of new or modified equipment, facilities, and utilities. The main objective of commissioning is to ensure the safe and orderly handover of the unit from the constructor to the owner, guaranteeing its operability in terms of performance, reliability, safety, and information traceability. When executed in a planned and effective way, commissioning normally represents an essential factor for the fulfillment of schedule, costs, safety, and quality requirements of the project. Responsibilities Develop, Execute and Implement Validation Documentation - Specification...

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

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

Reporting to the Associate Director for Privacy Compliance, Global Privacy Office, the “Privacy Manager, U.S." is an individual contributor that will play a key role in leading and advancing AbbVie’s U.S. privacy program, serving as a subject matter expert and point of contact for privacy matters, including pharmacy operations. This role will drive AbbVie’s U.S. data privacy compliance program, including privacy impact assessments, audits, privacy reviews, patient-facing materials, and HIPAA requirements. The Privacy Manager, U.S. will also be responsible for strengthening the overall maturity of AbbVie’s privacy obligations and coordinating with cross-functional teams to ensure enterprise-wide privacy compliance. Major Responsibilities...

Purpose Describe the primary goals, objectives or functions or outputs of this position. AbbVie’s Global Internal Audit function plays a critical role in protecting and enhancing the organization’s value through risk-based assurance and advisory services to internal stakeholders, senior management, and our Audit Committee of the Board. Internal Audit strives to be a critical function to evaluate company, industry and emerging risks, effectively partnering with the business, and consistently recruit and develop key talent. Our goals are carried-out through the talent of the audit team, while leveraging analytical and audit tools, supported by a dynamic and collaborative team culture. The...

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...

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...

Lead development and implementation of CMC regulatory strategy for small molecule investigational drugs in global Phase 1-3 clinical trials and marketing applications. Influence the regulatory strategy of Recursion’s development programs by attending team meetings, providing drug substance or drug product recommendations for US, EU and Rest of World (ROW) regulatory requirements/guidance interpretation, and best practices for CMC submissions and meetings. Strategize , plan, write, manage internal and external contributors and review region specific investigational stage CMC summary submission documents (Module 2, Module 3, IMPD, etc.) and agency requests. Deliver high quality regulatory US, EU and ROW submissions, strategy and advice....

Recursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential targets, using technology and standardization to build connected data, and superlinearly scaling our efforts to accelerate the delivery of high-potential drug candidates to the clinic. We are seeking a Director of Regulatory Affairs who will play a critical role in supporting global regulatory strategy, overseeing processes, and identifying and managing regulatory risks for the assigned programs. Collaborate with cross-functional leads to support the development of regulatory strategies and implementation for all jurisdictions as applicable to the program. Plan and perform critical reviews of...

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

As a Medical Director, Senior Patient Safety Physician , you are a senior leader within Patient Safety and play a key role bringing deep clinical understanding and judgement in benefit risk assessments for AstraZeneca products. You also have a role in shaping the culture of the department; and will act as a coach and mentor to more junior Patient Safety staff. You will also ensure projects adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements. We encourage you to closely follow medical developments within assigned areas to incorporate emerging data and trends into the safety strategy Main Responsibilities ...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Quality Systems Specialist Complaints to be located in Gurabo, PR. The Quality Systems Specialist – Complaints is responsible for ensuring that the handling of complaints complies with established company and...

Senior Professional Quality Assurance This role focuses on leading quality-related activities to ensure compliant, high-quality processes, documents, and products for Abbott Diabetes Care. The position oversees the development, implementation, and continuous improvement of Troubleshooting Guidelines (TSGs), while managing workflows, change requests, and cross-functional projects to meet timelines and regulatory requirements. It also involves active participation in Quality System processes, driving process improvements, and collaborating with stakeholders to ensure operational excellence. This is an onsite position that requires the individual to be in the office Monday-Friday. What You’ll Work On Responsible for carrying out tasks related to core job responsibilities...

FUNCTION Regulatory Affairs Business Operations – RA Human Capital POSITION OVERVIEW This role reports into the head of RA Human Capital which sits within RA Business Operations. RA Business Operations is key group within the broader global Regulatory Affairs organization and is a strategic partner and advisor to other Regulatory Affairs functions and teams and their partners and stakeholders. RA Business Operations helps ensure that the worldwide Regulatory Affairs organization operates with the highest standards of quality, efficiency and compliance, while further supporting strategic decision-making and continuous improvement. RA Business Operations provides a broad range of expertise and services such...

The Science and Regulatory Policy team is responsible for developing our company’s science and regulatory policy positions and advocating those towards industry thought leaders and regulators. The Executive Director, Enterprise Regulatory Policy Strategy provides strategic direction for our company's enterprise level regulatory policy approach across regions and markets. The Executive Director (ED) will be a strong subject matter expert in regulatory processes, policies, laws, and regulations, with a deep understanding of how regulatory policy is shaped and influenced, and the credibility, relationships, and strategic judgment required to drive alignment and advance regulatory policy priorities in direct support of our Research...

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

Responsible for leading the US and Above Markets C&E Team. Partner with the US SVP Therapeutic Area Leads to ensure US Commercialization strategies and tactics are compliant by design. Partner with the Above Markets Commercialization, Development and Corporate Functions to ensure awareness and adherence to applicable BMS compliance policies. Key Responsibilities/Leadership Promote the right tone throughout the organization and, working with the regional business leadership team, ensure a steadfast commitment by all employees to integrity, quality, compliance, and uncompromising ethics. Closely collaborate with the C&E leadership team and C&E Centers of Expertise team to (i) direct, prioritize and coordinate compliance...

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

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

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. Your role is crucial in maintaining this commitment and driving forward our...

We anticipate the application window for this opening will close on - 21 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Cardiac Ablation team within the Electrophysiology...

The Quality Engineer is responsible for carrying out Supplier Quality Assurance functions supporting AbbVie Lake County manufacturing sites including oversight of the Approved Supplier List, supplier qualification, supplier performance and maintenance, supplier audits, and supplier corrective action requests. This role collaborates with internal and global teams to support site QA responsibilities including investigations, impact analysis, corrective and preventive actions, quality system compliance, approval of standard operating procedures, quality improvement programs, and assurance of cGMP and AbbVie policy compliance for the manufacturing plants. Responsibilities Responsible for maintenance of the approved supplier list including material, service, and supplier qualification, performance, and discontinuation....

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

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 Johnson & Johnson is recruiting for a Senior Quality Engineer, located in Santa Clara, California. This is a fully onsite position. Our team advances the MONARCH™ surgical robotics platform by providing quality engineering support and leadership for design of new products and design changes for commercial products. We collaborate on breakthrough medical technologies that unite multiple subject areas to improve patient outcomes...

Employer Biosense Webster, Inc. Senior Quality Engineer Job Code A011.5775 Job Location Irvine, CA Job Type Full-Time Rate of Pay $140,774 - $149,220 Job Duties Lead Quality Engineering for the New Product Development Core team developing new technologies for the treatment of various cardiac arrhythmias. Responsible for design verification and validation activities for device in development. Support the development of design solutions. Perform complex tests and analyses to ensure that products are aligned with established specifications. Perform statistical analysis of data generated, including but not limited to process capability, Cpk, Ppk, Gauge R&R, ANOVA, Sample Size determination, and variable/attribute...

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

About the role As the Director, Clinical Program Quality, you will shape and lead a proactive, risk-based quality management strategy across clinical assets, driving exceptional clinical program performance, strengthening regulatory confidence, and accelerating time to market through the early identification and mitigation of systemic compliance risks. You will serve as a trusted strategic advisor within key asset-level governance forums, including the Global Program Team, Clinical Sub-Team, and Clinical Review Board, providing objective guidance on emerging risks, critical quality issues, and mitigation strategies that protect program continuity and maximize asset value. You will lead real-time inspection readiness across all Study Execution...

In this vital role, you will be a key member of the team that investigates major d eviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including, Process Development , Facilities & Engineering, Automation, EHS S, and Quality . This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process. Responsibilities include Manage the site's most complex major deviation investigations, including assembling investigation teams, leading advanced root cause analysis, development of CAPAs, and compliant documentation of...

USE YOUR POWER FOR PURPOSE Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. WHAT YOU WILL ACHIEVE In this role, you will Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications. Conduct rigorous sampling and statistical process control procedures to identify deviations from standards. Approve investigations and change control activities to maintain compliance...

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

We anticipate the application window for this opening will close on - 21 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Join us at Medtronic, where we are...

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

We anticipate the application window for this opening will close on - 24 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Principal Supplier Quality Engineer for New...

We anticipate the application window for this opening will close on - 21 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we bring bold ideas forward...

Chief of Staff, Senior Director Global Regulatory Affairs Introduction to role The Chief of Staff ( CoS ) serves as a strategic partner to the VP, Head of Global Regulatory Affairs, enabling effective leadership, decision making, execution, and communication across the Global Regulatory Affairs organization. The role acts as an extension of the VP, ensuring alignment between strategy and execution, optimizing governance and leadership forums, and driving cross functional coordination at enterprise level. This role combines strategic advisory, operational leadership, and executive facilitation, with a strong focus on prioritization, organizational effectiveness, and delivery of strategic objectives . Accountabilities Strategic Partnership...

The Director, Regulatory Affairs Data Standards and Governance is responsible for driving awareness and implementation of data standards and associated best practices in systems to support Regulatory Requirements for data submissions and to enable Regulatory data to connect with data sourced from other functions including R&D Development, Supply Chain, Operations and Quality Assurance. This role has functional responsibilities within RIM, in addition to performing a key role within the cross-functional Enterprise Product Master Data (EPMD) Data Office initiative. Responsibilities Demonstrates leadership within the Product Data Governance Office, building and executing lean and effective Data Governance processes. Support the Product Data...

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

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

As Device Quality Engineer - Device Risk Management and Surveillance Excellence within our Global Device and Packaging Unit (GDPU), you will lead critical global processes for patient safety and regulatory compliance. You are accountable for maintaining and continuously improving Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes, ensuring Medical Devices and Drug-Device Combination products comply with ISO 14971, MDR, and other relevant regulations throughout their lifecycle. You will deliver expert quality support for risk management and post-market surveillance activities across the development pipeline and post-launch lifecycle management. The role involves collaborating with cross-functional teams and external stakeholders to ensure...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As the Senior Manager, Quality Control at Gilead you will manage the Quality Control Chemistry or Microbiology laboratory operation, ensuring laboratory processes...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Quality Assurance Specialist at Gilead you will have the following responsibilities Manages, prioritizes, and participates in batch record review...

Quality Engineer This position works out of our Santa Rosa, CA location in the Toxicology business within Abbott's Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Quality Engineer will execute highly complex and specialized quality assurance projects supporting Abbott's Toxicology business, including clinical and forensic laboratory operations, drugs-of-abuse testing, quality systems compliance, and continuous improvement initiatives. This role applies advanced quality principles and...

Acelis Connected Health (ACH) operates accredited Durable Medical Equipment (DME) and Independent Diagnostic Testing Facility (IDTF) businesses across all 50 states, supporting more than 80,000 patients through innovative connected healthcare solutions. The Director, Quality Systems & Regulatory is a key leadership role responsible for developing and executing strategies that maintain and expand patient access while ensuring compliance with The Joint Commission accreditation standards, state licensing requirements, CMS regulations, and Abbott corporate quality standards. This leader will oversee Quality Systems and Regulatory Affairs activities across ACH, driving operational excellence, regulatory compliance, inspection readiness, and continuous improvement. The role requires close partnership...

This Senior Regulatory Affairs Specialist will work out of o ur Pleas a nton , CA location in the Heart Failure Division. As an individual contributor in the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department . With limited supervision you will execute tasks and partner across business functions. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities. What You’ll Work On As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports,...

Design Quality Engineer This position works out of our Dallas, TX location in the Transfusion Medicine , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. As the Design Quality Engineer , you will be a member of the cross functional team for Hardware that identifies, implements, and verifies changes to the design of Abbott products. Familiarity with design inputs, engineering drawings and specifications, risk...

Job Title Specialist, Quality Assurance This position works at our Westford, MA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. THIS IS AN ONSITE REQUIRED POSITION. What You’ll Work On Provides technical assistance to engineering to support manufacturing efforts by implementing corrective and preventative actions. Assists engineers in developing methods and procedures to control or improve manufacturing processes. MAIN RESPONSIBILITIES Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Performs returned goods analysis and enters data for post-market surveillance activities. Assists engineering in providing...

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. The position will be rotational, first starting in risk management and patient safety, and then moving into operations quality. 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 external requirements Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements Assist in the development and execution of streamlined...

We are searching for the best talent to join our DePuy Synthes Orthopaedics team as a Regulatory Affairs Manager . This position may be based in Raynham, MA; West Chester, PA; Palm Beach Gardens, FL; Synthes, Oberdorf; Zuchwil 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 Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value...

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

Own the worldwide, end-to-end regulatory strategy across multiple therapy areas supporting the Vascular $3B portfolio. Directly influence pipeline, investment, and global market access decisions. This is an opportunity to build the next-generation regulatory operating model. Serve as the regulatory leader across the Vascular portfolio, driving portfolio-level strategy, prioritization, and executive decision-making. This role shapes how regulatory strategy influences business investments, pipeline sequencing, and global market access, while leading teams across pre-market, on-market, and franchise-aligned functions. WHAT YOU’LL WORK ON KEY RESPONSIBILITIES Lead regulatory strategy across vascular franchises. Define governance and decision-making frameworks. Identify and mitigate regulatory risks while aligning with...

Location Cambridge MA Internal Director LI#-Hybrid This role oversees the Study Quality and Compliance team within the Toxicology line function of Preclinical Safety (PCS). This team is responsible for handling samples and data associated with both internally and externally conducted toxicology studies; maintaining departmental SOPs, and oversight of training records for departmental personnel; and interfacing with the archives function to ensure proper storage of toxicology-related materials and records. A major part of this role will be to identify and implement a software system that enables effective tracking and analytics of study-related information that this group is responsible for overseeing. ...

This role leads the development, implementation, and global governance of Environmental, Health, and Safety (EHS) programs within assigned scope. The position helps drive compliance, reduce risk, and minimize EHS-related liability while supporting a safe and sustainable business. Candidates would be considered based at any AbbVie site Responsibilities Provide global oversight of EHS regulatory compliance. Own the Global EHS Regulatory Monitoring and Impact Analysis Program, including monitoring regulations and enforcement trends, performing impact assessments, implementing compliance action plans, and tracking global compliance. Oversee site legal EHS registers and provide support as needed. Deliver regulatory updates to the EHS network and leadership....

The Senior Manager, Quality Engineering provides leadership, direction, and technical oversight for the Quality Engineering team within Operations. This role leads quality engineers who support manufacturing processes and provide quality engineering expertise for product, process, equipment, utility, and facility-related activities. The position ensures effective implementation of AbbVie Quality Systems and supports validation, qualification, and risk-based compliance decisions across base business and development or market expansion initiatives. The Senior Manager also manages functional resources and budget while maintaining strong quality, compliance, and operational performance. Responsibilities Leads and develops a team of quality engineers supporting manufacturing process quality oversight, validation, qualification, and...

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. Organizational Overview Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazers in FcRn inhibitor technology, the Company is boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Immunovant is seeking an Associate Director, CMC Quality Assurance (QA) to play a key...

The Principal RA Specialist will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This is an exciting opportunity with responsibilities for leading global regulatory submissions, which include but not limited to premarket submissions, pre-submissions and clinical trial applications, which include medical hardware and digital health technology solutions to address the spectrum of customer needs. This individual has department level influence...

Sr Specialist QA - Compliance What you will do In this vital role you will c oordinate all site logistics for regulatory inspections, corporate audits, internal audits, and customer audits across both manufacturing facilities. Also serve as a primary site coordinator for inspection readiness activities, including planning rooms, schedules, escorts, subject matter expert support, document retrieval processes, communications, and daily inspection management. Key Responsibilities Partner across functions to maintain a continuous inspection-ready state for a multi-product GMP manufacturing operation. Develop, maintain, and continuously improve site inspection readiness programs, tools, trackers, playbooks, and governance processes. Coordinate cross-functional readiness plans for...

The Operational Area Quality Senior Manager provides quality leadership for assembly manufacturing operations supporting medical device and combination products. The role is responsible for quality oversight of manufacturing operations, product disposition, batch record review, deviations, investigations, CAPAs, change controls, supplier quality, and regulatory compliance while partnering with manufacturing, engineering, supply chain, and external manufacturing partners. The position also supports design quality activities to ensure manufacturing changes remain aligned with design control and risk management requirements throughout the product lifecycle. ⸻ Key Duties and Responsibilities - Lead Quality Assurance support for assembly manufacturing operations of medical device and combination products, ensuring...

The Quality Systems Associate Director supports strategic design of and ensures tactical execution of quality systems, risk management, and quality culture across the Vertex Cell and Gene Therapy (VCGT) organization. The role is responsible for partnering with cross-functional technical development and commercial teams to align and facilitate harmonization of strategy, procedures and processes related to the Quality Management System and to drive Quality improvements. This position reports directly to the Director of Quality. Key Duties & Responsibilities The responsibilities of this position may include, but are not limited to, the following -Process Lead for Annual Product Quality Review (APQR) and...

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

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

This position works out of our Temecula, CA location in the Abbott Vascular Division. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. MAIN RESPONSIBILITIES Provide support to QA activities for regulatory compliance (i.e. Management Review support, regulatory audits). Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and...

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 Senior Quality/Test Engineer I is responsible for leading the testing efforts for all software components of an end-to-end clinical assay. Responsibilities include overseeing the overall test strategy, planning, and release of all software components. This is a...

This role leads the development, implementation, and global governance of Environmental, Health, and Safety (EHS) programs within assigned scope. The position helps drive compliance, reduce risk, and minimize EHS-related liability while supporting a safe and sustainable business. Candidates would be considered based at any AbbVie site Responsibilities Provide global oversight of EHS regulatory compliance. Own the Global EHS Regulatory Monitoring and Impact Analysis Program, including monitoring regulations and enforcement trends, performing impact assessments, implementing compliance action plans, and tracking global compliance. Oversee site legal EHS registers and provide support as needed. Deliver regulatory updates to the EHS network and leadership....

This role leads the development, implementation, and global governance of Environmental, Health, and Safety (EHS) programs within assigned scope. The position helps drive compliance, reduce risk, and minimize EHS-related liability while supporting a safe and sustainable business. Candidates would be considered based at any AbbVie site Responsibilities Provide global oversight of EHS regulatory compliance. Own the Global EHS Regulatory Monitoring and Impact Analysis Program, including monitoring regulations and enforcement trends, performing impact assessments, implementing compliance action plans, and tracking global compliance. Oversee site legal EHS registers and provide support as needed. Deliver regulatory updates to the EHS network and leadership....

This role leads the development, implementation, and global governance of Environmental, Health, and Safety (EHS) programs within assigned scope. The position helps drive compliance, reduce risk, and minimize EHS-related liability while supporting a safe and sustainable business. Candidates would be considered based at any AbbVie site Responsibilities Provide global oversight of EHS regulatory compliance. Own the Global EHS Regulatory Monitoring and Impact Analysis Program, including monitoring regulations and enforcement trends, performing impact assessments, implementing compliance action plans, and tracking global compliance. Oversee site legal EHS registers and provide support as needed. Deliver regulatory updates to the EHS network and leadership....

This role leads the development, implementation, and global governance of Environmental, Health, and Safety (EHS) programs within assigned scope. The position helps drive compliance, reduce risk, and minimize EHS-related liability while supporting a safe and sustainable business. Candidates would be considered based at any AbbVie site Responsibilities Provide global oversight of EHS regulatory compliance. Own the Global EHS Regulatory Monitoring and Impact Analysis Program, including monitoring regulations and enforcement trends, performing impact assessments, implementing compliance action plans, and tracking global compliance. Oversee site legal EHS registers and provide support as needed. Deliver regulatory updates to the EHS network and leadership....

2nd shift Quality Engineer II This position works out of our Minnetonka, 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 2nd shift Quality Engineer II , you’ll support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a...

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

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

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

The Associate Director Global Quality Systems is a key global Operations role responsible for the end-to-end ownership, governance, and continuous improvement of core Quality processes and their supporting digital systems. Operating within a matrixed organization, the role leads a global process network to ensure standards, procedures, systems, and ways of working are aligned with cGMP , GxP , ICH , and internal Quality Management System requirements. The role combines process leadership , quality systems expertise , compliance oversight , performance management , and digital transformation . The Associate Director Global Quality Systems drives standardization, simplification, harmonization, and innovation across the...

About the role Develop and Implement Environmental Programs and Initiatives Lead the creation and execution of Takeda’s enterprise environmental compliance and management programs, including natural resource conservation (e.g. water, biodiversity, waste, etc.), risk management and hazardous waste management. Strategic Leadership and Collaboration Provide EHS S leadership by collaborating with cross-functional teams to integrate best practices into enterprise business processes and continuously improve manufacturing operations while enhancing environmental sustainability. Regulatory Compliance and Advocacy Direct environmental due diligence and represent Takeda in regulatory engagements, ensuring compliance with emerging global regulations and fostering sound environmental policies. Operational Climate Strategy Oversight Oversee the development,...

We anticipate the application window for this opening will close on - 23 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Senior Supplier Quality Engineer for New...

We anticipate the application window for this opening will close on - 25 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Pelvic Health Our Pelvic Health Operating Unit...

This role reports to the Senior Director, Quality, EM&S Gen Med NA and is part of a team that has primary responsibility for providing quality oversight for 3rd party subcontractors such as CMOs, suppliers, and contract labs, to oversee activities of QA/QC and compliance functions to ensure compliance with current Good Manufacturing Practices (cGMPs) and Quality Management System (QMS). This position interacts extensively with North American manufacturing/packaging sites, contract manufacturers, and with sites inside and outside the U.S. which manufacture products that include all dosage forms for numerous global markets. The individual works closely with the contractors, quality team, supply...

The Associate Director, RBQM will mainly be responsible for developing the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk and issue management. Provide quality and compliance consultation to clinical trials teams throughout study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun. Key Responsibilities Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data,...

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

About the role Th e Quality Strategy & Innovation (QSI) role leads the site Quality transformation agenda and helps ensure alignment across site, regional, and global Quality priorities. As a strategic partner to the Site Quality Head, this role focuses on transformation, capability building, and value creation to strengthen Quality performance, operational efficiency, and compliance. How you will contribute Translate global and site Quality strategy into clear, actionable plans for the site. Lead the Quality transformation roadmap and support prioritization of the improvement portfolio including resource alignment. Partner with Business Excellence and cross-functional teams to drive execution and track progress....

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

As Regulatory Strategy & Continuous Improvement - Platform Lead within our R&D team , you will lead multiple interconnected initiatives involving diverse stakeholders across the organization, orchestrating multiple concurrent programs with varying timelines, priorities, and resource requirements across global regulatory landscapes. You will establish and maintain global responsibilities across GRA CMC & GRA Device departments, build and manage cross-functional governance structures to facilitate decision-making, identify synergies between parallel projects to leverage shared resources, and establish metrics and KPIs to track progress and drive continuous improvement. Additionally, you will facilitate resolution of cross-project dependencies and conflicts, develop communication strategies to maintain...

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

Purpose Describe the primary goals, objectives or functions or outputs of this position. AbbVie’s Global Internal Audit function plays a critical role in protecting and enhancing the organization’s value through risk-based assurance and advisory services to internal stakeholders, senior management, and our Audit Committee of the Board. Internal Audit strives to be a critical function to evaluate company, industry and emerging risks, effectively partnering with the business, and consistently recruit and develop key talent. Our goals are carried-out through the talent of the audit team, while leveraging analytical and audit tools, supported by a dynamic and collaborative team culture. The...

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...

We anticipate the application window for this opening will close on - 21 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Business Group Global Quality / Enterprise Quality...

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 Senior Principal Quality Engineer – Design Quality & Systems Excellence role to be located at Danvers, MA. 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...

About the Role As Director, Clinical Program Quality & Excellence (CPQE), TAU, you will provide strategic quality leadership across clinical assets, driving a risk-based quality management approach that enhances program performance, strengthens regulatory confidence, and supports faster delivery of innovative therapies to patients. You will influence key portfolio decisions by providing insights on emerging risks, critical quality issues, and mitigation strategies, while leading inspection readiness across Study Execution Teams and ensuring compliance with global GCP and regulatory expectations. Through strong partnership with senior stakeholders, you will champion a culture of quality by design, accountability, and scientific rigor that protects patient...

About the Role As the Senior Director, Head of Clinical Program Quality & Excellence (TAU), you will drive a risk-based quality management approach across the Therapeutic Area Unit, strengthening clinical program performance, regulatory confidence, and inspection readiness. You will provide quality leadership to key governance bodies, identify and mitigate emerging risks, and lead the Clinical Program Quality & Excellence team to embed operational excellence, patient safety, data integrity, and global regulatory compliance across clinical trial delivery. Additionally, you will help advance enterprise quality strategies, influence senior stakeholders, and foster a culture of quality by design, accountability, and continuous improvement. You...

Senior Compliance Specialist This position works out of our Altavista, VA 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. Altavista, Va. , is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you...

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

We are now recruiting a n Associate Director , R&I Clinical Regulatory Writing ( CReW ) . A s part of a clinical delivery or submission team, the Associate Director provide s strategic communications leadership to projects, establish es communication standards and best practice, and continuously advocate s for quality and efficiency. The Associate Director also a uthor s strategic clinical-regulatory documents and provid es critical review to achieve high-quality standards, utilizing best practices for document and accelerated submission delivery . What You will Do The Associate Director, CReW , is expected to Independently manage clinical regulatory writing activities across...

The Senior Manager, Regulatory Strategic Planning, is responsible for successfully delivering project management capabilities for cross-functional teams of medium- to high-complexity within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business processes to properly drive the execution of AbbVie’s regulatory strategies. The Senior Manager will be developing and managing the schedules, activities, and deliverables for the Global Regulatory Product Teams (GRPTs), interacting with key stakeholders, and leading process improvement efforts to help achieve business performance goals for regulatory compliance and productivity. Responsibilities Provides project management leadership in support of GRPTs; develops schedules and wave...

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

Specialist Quality Assurance Location Easton, Pennsylvania - ON-SITE What you will do Let’s do this! Let’s change the world! This onsite position provides critical support for the Raw Material Center (RMC) warehouse, based in Easton, Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network, serve additional manufacturing sites, and facilitate inventory pooling and bulk purchasing. RMC services encompass direct supplier receipt, incoming quality inspection and sampling, environmental monitoring, storage, and transportation. Responsibilities Ensure that all operations align with relevant regulations and Amgen requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and...

Johnson & Johnson is currently recruiting for an Innovative Medicine Transformation IT Compliance Senior Manager (Transcend Program) and the role will be based in Titusville, NJ and other J&J offices. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact...

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

The Principal Quality Engineer – DevOps is responsible for ensuring that AbbVie's IT operations and software lifecycle processes fully comply with regulatory requirements and corporate standards. This role provides leadership in defining, implementing, and optimizing quality systems through digital enablement and AI-driven solutions, and involves direct collaboration with cross-functional teams, Business stakeholders, and the Business Technology Services (BTS) Quality organization. This techno-functional expert transforms traditional quality assurance by implementing automation frameworks and DevOps best practices that enhance efficiency, reduce cycle times, and ensure regulatory compliance while optimizing CI/CD pipelines The Principal Quality Engineer – DevOps will provide oversight of quality...

The Principal Quality Engineer – Automation and AI Enablement is responsible for ensuring that AbbVie's IT operations and software lifecycle processes fully comply with regulatory requirements and corporate standards. This role provides leadership in defining, implementing, and optimizing quality systems through digital enablement and AI-driven solutions, collaborating directly with cross-functional teams. Focusing on modernizing communications, metrics management, SLC monitoring activities, and providing end-to-end audit and Corrective and Preventive Action (CAPA) support, the incumbent leverages automation and AI to strengthen cross-functional integration and quality oversight. They drive improvement initiatives, support audit readiness, ensure effective issue tracking and resolution, deliver actionable insights...

Primarily responsible for ensuring adherence to GLP regulations and developing an organizational model for the global Quality Assurance Unit. Manage a team of audit professionals responsible for quality oversight of all non-clinical GLP and GCP regulated studies. Responsibilities Management of the Preclinical Quality Assurance Team including the Preclinical QA Audit Program. Ensure adherence to GLP and GCP laboratory regulations. Collaborate with GXP Vendor Compliance to ensure all external vendors, who provide materials and services on behalf of AbbVie, are appropriately approved priorto use. Develop an organizational model for internal GLP audit coverage and ensure appropriate capabilities and resources...

Beam is seeking a highly talented and motivated Associate Director to join our Compliance and Quality Systems team. The Associate Director serves as the enterprise owner of treatment center onboarding and quality integration, ensuring the efficient, compliant, and scalable activation of commercial treatment centers across the network. This role develops and leads the end-to-end onboarding strategy, coordinating cross-functional stakeholders to accelerate treatment center readiness while maintaining the highest standards of quality, compliance, and operational excellence. As the single business owner for all treatment center agreements, the Associate Director provides governance over quality assessments, quality agreements, periodic re-evaluations, and related documentation,...

Beam is seeking a highly motivated and energetic Senior Analyst to join the QC analytical team. The Senior Quality Control Analyst, Analytical Methods will primarily support critical analytical method implementation workstreams including method qualification, validation, and transfers to enable start-up and scale-up of cGMP manufacturing operations across multiple site programs. The Senior Analyst will work collaboratively with cross-functional teams to plan and execute method qualification and validation activities to drive program advancement and support critical company milestones. In addition to method lifecycle-focused work, this role will contribute to routine GMP testing ensuring continuity of QC support for both in-process, release...

Employer Shockwave Medical, Inc. Supplier Quality Engineer II Job Code A011.10389.2 Job Location Santa Clara, CA Job Type Full-Time Rate of Pay $170,248 - $171,000/year Job Duties Partner with Procurement, R&D, Operations, Quality, and Suppliers to ensure timely investigation, resolution, and prevention of supplier quality issues that could disrupt business operations. Monitor and analyze supplier performance metrics, identify improvement opportunities, and communicate supplier risks and/or opportunities to the next level of management. Participate in the planning, scheduling, execution, and reporting of supplier audits. Participate in the initiation, issuance, review, and approval of Supplier Corrective Action Reports (SCARs). Drive corrective...

ROLE SUMMARY The QMS/V&C Lead is responsible for driving GWE R&D Compliance Program and Systems across Global sites. The incumbent will oversee, manage, and assure overall adherence to the Compliance Program for GWE R&D and drive GWE’s Continuous Improvement approach to service, customer and compliance assurance. The QMS/V&C Lead supports GWE R&D by driving strategy, compliance requirements, control, quality, and continuous improvements. In the Compliance area, the Director provides strategy, management advice, ownership, and guidance to all applicable GWE R&D functions by identifying short-term and long-term strategy, daily interpretation, and application of compliance requirements for services managed by GWE R&D....

Supplier Quality Engineer II 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. Responsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers. Must be able to handle supplier audit situations and interactions in a tactful, professional and effective manner. What You’ll Work On Supplier Audits Develop and execute to a supplier audit schedule per current requirements. Develop audit plans and associated supplier communications. Approve and monitor Supplier...

Quality Engineer II Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. 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 external requirements Lead in the implementation...

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Supply Chain/Warehouse Operations. This position will oversee and partner with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shift NIGHT shift, 6 PM – 6 AM, Panama schedule (12-hour shift patterns with a 2-2-3 work cycle, including weekends and holidays) The Specialist, QA Shop Floor, is accountable to own quality decision making as it relates to unexpected events on the production floor, including deviation triage and determination,...

Are you passionate about Regulatory Writing? Would you like to have an impact on patients’ lives and contribute to eliminate cancer as a cause of death? If so then join us! Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science....

The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products . This role will be responsible for the development and maintenance of global product labeling across a therapeutic area. This will include target labeling profiles (TLP), company core datasheets (CCDS) and local labeling (prescribing information, patient information) for major markets. This role will be accountable for specific labeling business processes. Key Duties and Responsibilities Ensures compliance with labeling governance requirements and associated business processes. Leads label working groups (LWG) and represents labeling at product-specific global regulatory teams and senior labeling governance meetings...