Quality & Regulatory Jobs in Pharma & Biotech

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...

We anticipate the application window for this opening will close on - 20 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 exciting role as a Senior...

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 - 18 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 one of three comprehensive portfolios ...

We anticipate the application window for this opening will close on - 17 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 A career at...

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,...

Brief Description of Position The Associate Director Quality Systems & Compliance within Device Quality & Regulatory will support our company's Manufacturing Division QMS Topic 3.3 – MDCP Design Controls and lead continuous improvement initiatives that support every aspect of our business processes, systems, and data. The Associate Director will collaborate with cross-functional teams to identify opportunities for improvement, address internal/external audit observations and tackle challenges, balancing effective operations with transformative initiatives. The Associate Director will work with the manufacturing division's Topic 3.3 Owner and Business Owner and has responsibility for oversight and lifecycle management of procedures related to this specific...

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...

Professional Quality This position works out of our Dallas, TX or Lake County locations 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. Professional Quality will conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes, which adds value to the business. What You’ll Work On Contributes to defining and timely achievement of overall project goals. Scope typically...

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...

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 Sr. Regulatory Affairs Professional, Global TA , located in Spring House, PA, Raritan or Titusville, NJ. Purpose Global Regulatory Affairs (GRA) is looking for a high energy, inventive, self-starter who...

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 Analyst Quality Control The QC Analyst conducts biochemical, microbiological, and/or general chemical testing of raw material, in-process, or final product samples submitted to the QC laboratories. The position requires testing to...

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...

Job Title Director, Regulatory Affairs Strategy - Cell Therapy 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 global teams, you will lead strategy across key milestones—from expedited designations and Health...

JOB SUMMARY The Senior Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides comprehensive program management, ensuring alignment and execution of Pfizer Oncology’s regulatory strategic and operational deliverables. The Senior Manager, RPMSS is responsible for ensuring all cross-functional regulatory deliverables are achieved on or ahead of schedule and with quality that meets or exceeds business needs. The Senior Manager, RPMSS is viewed as a key member of the GRST (Global Regulatory Strategy Team). The Senior Manager, RPMSS’ responsibilities encompass regulatory strategic and scenario planning, execution of regulatory and submission deliverables, team effectiveness, resource management, risk management, and information and communication...

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...

The Laboratory Specialist within the Quality Operations department, with guidance from the Associate Director of Quality Operations, provides support to Laboratory Operations. The Laboratory Specialist will support sample tracking and scheduling, perform performance trends, manage inventory, facilitate collaboration meetings, engage in project work, and support other business needs at the direction of the Associate Director. The Laboratory Specialist will work closely with the assigned laboratory in a team environment to ensure timely turnaround of laboratory testing and to ensure that documentation is completed right the first time. The Laboratory Specialist will work with Laboratory Operations staff and management coordinate day-to-day...

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. ...

The Director of Regulatory Information Management (RIM) is responsible for translating broader Regulatory Information Management Services (RIMS) and Regulatory strategy into execution within assigned scope, advancing regulatory information capabilities, and ensuring efficient, consistent, and compliant management of Regulatory information.This position provides strategic leadership for business processes, data quality, system enhancements, and continuous improvement initiatives within area of responsibility. The Director partners closely with Regulatory, BTS, Business Process Owners, and other cross-functional stakeholders to deliver business value, strengthen compliance, and improve operational effectiveness.The Director manages a small team and is accountable for team performance, capability development, and delivery of high-impact work...

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

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 Manager, Medical Device External Quality is part of AbbVie’s External and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality. The role will be based out of Lake County, IL site. This role primarily oversees external product quality assurance (EPQA) for commercial medical devices which are manufactured by third parties. In this capacity, the Manager, Medical Device External Quality, champions best practices related to sustaining product quality, equipment qualification, and manufacturing process validations. As such, the Manager, Medical Device External Quality works closely with AbbVie’s Contract Manufacturing Organizations (CMOs), relevant third-party suppliers (e.g., custom...

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...

Provide Quality Control (QC) leadership and ownership for site investigations and CAPA execution related to QC operations and laboratory activities. This role is accountable for ensuring investigations are scientifically sound, timely, and compliant, while partnering closely with Quality Assurance for independent oversight and regulatory alignment. Duties / Responsibilities Lead and manage the deviation and investigation process for Quality Control operations, including analytical testing, microbiology, bioassay, environmental monitoring, and laboratory systems. Serve as the QC subject matter expert (SME) for root cause analysis, CAPA development, and effectiveness verification related to laboratory and testing-related events. Ensure investigations are data-driven, scientifically rigorous, and...

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...

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...

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 Director, Regulatory Compliance, to be located at Irvine, CA. Purpose The Director, Regulatory Compliance is responsible for tactical and strategic compliance support to the Johnson and Johnson's regulatory compliance (JJRC) organization. This role provides regulatory compliance expertise and has independent compliance oversight to ensure regulatory standards are met. This role is responsible for leading...

We anticipate the application window for this opening will close on - 18 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 one of three comprehensive portfolios ...

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....

Purpose AbbVie is dedicated to delivering innovative, safe, and effective medicines and products that address critical health issues and make a remarkable impact on people's lives. As a Global Trade Compliance organization, we are committed to driving and pioneering best-in-class trade compliance practices in a dynamic global environment. The Sr. Analyst, GTC – Tariff Classification, is responsible for ensuring that AbbVie’s cross-border transactions are executed in compliance with import/export regulations worldwide. This Sr. Analyst will play a vital role in the leveraging of technology solutions in the tariff classification area that enables import/export compliance and supports cost savings activities globally....

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....

POSITION SUMMARY Quality Engineer is supporting early to late stage Laboratory development and In Vitro Diagnostic (IVD) Test. This is an exciting opportunity for an ambitious and dynamic individual to join a fast paced rapidly growing company. PRIMARY RESPONSIBILITIES Create, revise and update laboratory, equipment, facility, HIPAA Privacy & Security and quality processes compliance Develop and implement quality system documentation (operating procedures, work instructions, specifications etc.) Primary support for compliance activities (management of non-conformances, CAPA, environmental monitoring, process monitoring, audits, complaints investigations) Conduct or facilitate internal and external audit of product processes and recommend improvements (eg. Notified Body, FDA,...

Associate Quality Control What you will do In this vital role you will execute and review analytical testing in our cGMP laboratory. The role will be based out of Amgen Rhode Island and will work under the mentorship of the hiring manager. It is an administrative shift, Monday through Friday. The Raw Material Centralized Testing team provides analytical expertise in testing raw materials to meet Amgen specifications and ensure a constant supply of raw materials for Amgen products. The laboratory employs a variety of test methodologies that utilizes sophisticated equipment including HPLC, GC and ICPMS. The team provides these...

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...

This position works out of our Temecula, CA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for...

Reporting to the Executive Director, Innovation, Digital Enablement, and Analytical Solutions (IDEAS), the Senior Specialist role will support ECO by helping to build and enhance data-driven solutions with a focus on critical-to-compliance risk areas. This position is a hybrid role that sits at the intersection of technology and business and will be focused on supporting ECO-wide initiatives. The Senior Specialist partners with IDEAS team members and ECO stakeholders to understand business needs, translate them into technical requirements, and deliver well-tested solutions. Individuals in this role bring a strong technical foundation (data modeling, SQL, visualization software, various programming languages) and a...

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 Staff Source Quality Engineer to be located in Guaynabo, PR or Raritan, NJ. The Staff Source Quality Engineer provides global Source Quality leadership for direct and indirect suppliers and external manufacturers supporting Johnson & Johnson products. This role leads the deployment and execution of Source Quality Management strategies, supplier controls, and risk-based quality oversight...

DePuy Synthes is recruiting for a Sr. Source Regulatory Compliance Specialist, located in Palm Beach Gardens FL, Raynham MA, Warsaw, IN or West Chester PA. Job Overview The Sr. Source Regulatory Compliance Specialist is responsible for executing and supporting regulatory compliance activities related to sourcing, suppliers, and externally provided processes. This role ensures that suppliers, contract manufacturers, and sourced materials comply with applicable regulatory requirements, quality system standards, and internal policies. The position plays a key role in safeguarding product quality, supporting audit readiness, and enabling compliant supply continuity by partnering closely with Quality, Regulatory Affairs, Supply Chain, and Procurement...

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...

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...

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...

We anticipate the application window for this opening will close on - 13 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 position will support the Surgical...

We anticipate the application window for this opening will close on - 12 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 one of three comprehensive portfolios at...

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...

Johnson & Johnson MedTech, Electrophysiology, is recruiting a Manager, Contract Performance & Compliance. This position will be preferably based in Irvine, CA, however remote opportunities may be considered. Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity....

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...

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

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...

We anticipate the application window for this opening will close on - 14 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 – Warsaw, IN manufactures spinal...

Position Senior Specialist, Quality Assurance Investigations, Cell Therapy Location Devens, MA careers.bms.com/working-with-us The Senior Specialist, Quality Assurance Investigations, is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Devens Cell Therapy Facility. The role provides Quality oversight and assurance of the quality of manufactured products, in compliance with all applicable regulations and BMS policies and guidelines. Key Responsibilities Review and approve investigations/ CAPAs / effectiveness checks associated with the manufacturing site including but not limited to materials, manufacturing, laboratory, facility, and computer systems. May author, review, approve technical...

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

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...

POSITION DUTIES & RESPONSIBILITIES The Quality Engineer II should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. This individual will work in a design team setting. He/she will support new product development and design through design verification activity. This individual will support design control activities for new product development efforts. This individual will develop risk assessment, inspection methodology and acceptance criteria for inspection sample plans and conduct audits of new suppliers as part of the project teams. He/she will provide leadership in the understanding of medical device regulations to other disciplines. The Quality Engineer II will...

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...

The Executive Director, Chemistry, Manufacturing, Control for Biologics (Biologics-CMC) is accountable for managing a team of CMC professionals and ensuring rigor in CMC regulatory strategy as well as delivery of high quality CMC submissions for late phase new modality biologics products. The Executive Director, as a Senior member of the Global Regulatory Affairs and Clinical Safety Chemistry, Manufacturing and Control organization ( GRACS CMC), will also manage significant projects as an extension of the overall GRACS CMC Leadership Team. This lead plays a critical role in driving alignment and execution globally across Regulatory CMC (Chemistry, Manufacturing & Controls), GRACS (Global...

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. We are seeking an experienced, high caliber Quality Engineer I for our Sylmar, CA Operations Quality Engineering team. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support...

Manager Quality Assurance - Biochemistry This position works out of our Abbott Park, IL location in the Transfusion Medicine , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Manager of Quality Assurance - Biochemistry - is responsible for implementing and maintaining the effectiveness of the quality system. Manage the direct activities of an area within a department or function. Provides direct supervision to...

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...

2nd shift Quality Engineer II This position works out of our Menlo Park, CA location in the Structural Heart division. Structural Heart Business Mission why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business...

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...

Specialist Quality Assurance What you will do Let's do this. Let's change the world! In this vital role, you will serve as a Quality Assurance professional accountable for the review and approval of Change Controls, Validation documentation, Equipment and Facilities lifecycle documentation, Process Qualification (PQ), Process Performance Qualification (PPQ), Periodic Monitoring, Process Reviews, and Annual Product Reviews (APR), ensuring compliance with cGMP requirements while safeguarding product quality and patient safety through sound judgment, strong ownership, cross-functional collaboration, and effective risk management in a dynamic drug product manufacturing environment. Specific responsibilities include but are not limited to Serve as the Quality...

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...

We are searching for the best talent for a Director, Health Care Compliance Officer, Global Functions, for the Innovative Medicine business with responsibilities for areas within the Global Commercial Strategy Organization (GCSO) and Global Business Development. This role will primarily be based in Raritan, NJ. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step...

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...

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

Use Your Power for Purpose Our breakthroughs would not make it to the hands of patients without our dedicated and agile pharmaceutical manufacturing team. We rely on members who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have the medicines they need when they need them. The significance of your role cannot be overstated, as you help bridge the gap between innovation and patient care. By being part of this team, you contribute...

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....

About the role As a Quality Control Analyst II, you will perform compendial assessments to ensure compliance with current regulatory requirements and pharmacopeial standards. You will author and review technical documents, including protocols, standard operating procedures (SOPs), and analytical methodologies and design and coordinate analytical method onboarding activities, including execution planning, training, and documentation. How you will contribute Lead and manage the qualification of critical materials, ensuring fitness for use in analytical testing. Oversee change control management processes, including risk assessment, documentation, and implementation. Manage Corrective and Preventive Actions (CAPAs) related to analytical processes and support timely closure of quality...

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...

The role will be based in either Gaithersburg MD, Santa Monica CA or The Netherlands. The Senior QA Auditor positions establish a continuum at the senior lever for carrying out more challenging audits. These positions are responsible for audits of AstraZeneca Cell Therapy manufacturing sites, contractors, suppliers, due diligence and other audits where a higher level of skills and experience is required. Audits are conducted in accordance with local and international regulations/guidelines and company quality standards to assure compliance with cGMP`s. The incumbents possess advanced audit skills and specialised knowledge in one or more different areas e.g. sterile manufacture, API´s,...

The Director, Regulatory Data is responsible for leading the strategy, governance, execution, and continuous improvement of regulatory data management within Vertex’s Regulatory Information Management System (RIMS). This role provides leadership for the accurate collection, maintenance, quality oversight, reporting, and inspection readiness of critical regulatory data and documentation. The Director leads and develops a team responsible for regulatory data stewardship, establishes scalable processes and standards, and partners cross-functionally to ensure regulatory information is complete, reliable, inspection-ready, and positioned to support portfolio, operational, and compliance decision-making. Key Duties and Responsibilities Lead the Regulatory Data Management function, setting the vision, operating model, priorities,...

The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation of the global regulatory strategy for CGT products of high complexity and visibility and may serve as Franchise GRL on complex programs with multiple indications. In addition to GRL responsibilities, the Sr RAD has the ability to function in dual capacity by also serving as a regional lead based on their location. The Sr RAD ensures that the regulatory strategy is designed to deliver efficient approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets...

Position Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am-6pm - Rotating 2-3-2 Panama Schedule) Manager Manager, Quality Assurance Shop Floor Note This position works a rotating 2-3-2 Panama schedule (6am to 6pm ), Day shift. 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 Warehouse Operations. This position will oversee and partner with operational areas to ensure GxP compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. In the capacity of QA Shop Floor, the Specialist shall serve...

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

Responsible for assisting with the internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards. Responsibilities Assists with planning and conducting internal compliance audits of all operations within the facility. Provides support with company and regulatory agency (i.e. DEA, FDA) inspections. Follow up on audits to assure that action plans are developed and completed in a timely fashion. Assist with management review and associated metrics for the plant Provides support in the metrics collection and analysis for compliance-related corrective and preventive actions (CAPA’s). Responsible for...

The Senior Quality Engineer, Medical Device External Quality is part of AbbVie’s External and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality. The role will be based out of Lake County, IL site or Pleasanton, CA. This role primarily oversees external product quality assurance (EPQA) for commercial medical devices which are manufactured by third parties (TPM). In this capacity, the Manager, Medical Device External Quality, champions best practices related to sustaining supplier qualifications, product quality, equipment qualification, and manufacturing process validations. As such, the Manager, Medical Device External Quality works closely with AbbVie’s Contract...

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

We anticipate the application window for this opening will close on - 13 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...

Objective / Purpose Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, leading and/or contributing with influence to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for other global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities The Senior...

The Associate Director is responsible for the review and approval of all US promotional materials and serving as the promotional regulatory expert with legal, medical and commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, our Company's policies, and support business objectives. Serve as the liaison and manage correspondence with FDA’s promotional review divisions OPDP/APLB, including complex regulatory questions and submissions for advisory comment. Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk. Provide regulatory consultation in the development and implementation of US marketing strategy...

The Senior Validation Engineer/Analyst functions as the lead for maintenance, engineering, and validation activities within the assigned site/area of responsibility. Equipment, facility, utilities and cleaning are within the scope of responsibility. The incumbent is the primary liaison with the Operations, engineering services, and third party vendors for executing activities within area of responsibility. All responsibilities should be executed in a manner to ensure that product quality is maintained at the appropriate level to meet R&D and Corporate Quality Standards/Expectations. Responsibilities Manage departmental capital projects and miscellaneous engineering activities. Work with in-house functional support and outside vendors to coordinate required services....

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...

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...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access to transformative...

About the role The Director, Clinical Program Quality & Excellence (CPQE) serves as a strategic quality leader supporting Takeda’s clinical development portfolio. This role is responsible for shaping and executing risk-based quality management strategies across assigned clinical programs, ensuring inspection readiness, regulatory compliance, and proactive quality oversight throughout the clinical trial lifecycle. You will partner closely with global cross-functional stakeholders, including Clinical Development, Study Execution Teams, Regulatory Affairs, and Quality organizations, to identify emerging risks, drive issue resolution, and strengthen quality performance across clinical programs. This position plays a critical role in supporting portfolio decision-making, safeguarding patient safety, ensuring data...

We are searching for the best talent for our Analyst, Preclinical Compliance & Safety position to be located in Spring House, PA. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Purpose The Preclinical Compliance & Safety Team develops, maintains, and delivers compliance strategies and programs supporting non-GXP...

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

The Director, Global Patient Safety Individual Case Safety Report (ICSR) oversees global ICSR processing and external PV partners and vendors. This position manages the technical aspects of end-to-end safety case intake, processing, quality control, and regulatory submissions within a therapeutic area (as assigned) covering the applicable drug, biologic, medical device, and combination products, ensuring operations are consistent, compliant, and inspection-ready worldwide. The Director, Global Patient Safety Individual Case Safety Report (ICSR) plays a key role in global ICSR processing excellence and external business management. This position serves as a subject matter expert in pharmacovigilance (PV) and contributes to developing and...

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...

The Sr. Director, Corporate Quality, Pharmacovigilance will be responsible for the management of GVP quality oversight, GVP-related audit program and for providing regulatory/GVP guidance. The Opportunity to Make a Difference This position will liaise with internal groups such as Pharmacovigilance Operations, Safety Evaluation & Risk Management, and Market Research, as well as external groups including contract auditors in an effort to ensure a high level of quality and consistency across the Sarepta platform; design and oversee the audit strategy; assist the GVP team in identifying and implementing corrective and preventive actions; and enable teams to be inspection ready, in support...

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...

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

The Associate Director, International Regulatory Affairs Advertising & Promotion safeguards products and practices to adhere to the highest quality and regulatory standards. The Associate Director will be responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds. The Associate Director will interface with International Marketing, International Medical Affairs, Global Legal and Office of Ethics and Compliance with regard to advertising and promotion strategies and tactics intended for use globally. Responsibilities...

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

About the Role We are seeking a highly skilled Senior Manager to join our dynamic team supporting biologics regulatory submissions. In this role, you will serve as the lead author for key Module 3 Common Technical Document (CTD) sections. You will apply your analytical expertise and regulatory knowledge to deliver high-quality documentation in support of global regulatory submissions. You will be an integral member of cross-functional teams, collaborating closely with Quality Control, Quality Assurance, Regulatory, Analytical Research and Development, and Chemistry, Manufacturing and Controls (CMC) colleagues to deliver submissions to support commercial approval. The ideal candidate will have extensive analytical...

We are looking for a motivated and strategic regulatory professional to join our growing regulatory team at Relay Tx. You will contribute to the development and execution of innovative regulatory strategies to support the advancement of our transformative pipeline. You will support the global regulatory lead to drive regulatory planning and execution for our development programs. You will collaborate with cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA,NDA and MAA submissions. Your Role You will work closely with research and development colleagues to support the development and execution of innovative regulatory strategies for programs ranging from...

Job Title Process Quality Engineer This position works out of our St. Paul, MN (New Brighton) location in the Abbott Vascular division. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. What You’ll Do 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 Support the investigation, resolution and prevention of product and process nonconformances...

Johnson & Johnson is seeking a Manager, Quality Systems to lead and enhance escalation and field action processes while ensuring full compliance with global regulatory and corporate requirements. This position can be located in Jacksonville, FL or Irvine, CA This role is responsible for establishing, maintaining, and optimizing escalation processes and field action systems. The Manager will ensure alignment with local, national, and international regulations, as well as Johnson & Johnson policies and procedures. Key Responsibilities Lead and manage Issue Escalation RMB and Quality Review Board (QRB) processes, including Coordinating information gathering across sites and stakeholders Preparing materials and...

Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to 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....

The Senior Counsel, Data Governance, Law & Compliance provides legal and compliance leadership for enterprise data governance initiatives at Bristol Myers Squibb. Sitting within the AI, Data and Privacy Law and Compliance department and reporting to the Head of AI & Data Governance, Law and Compliance, this role partners closely with Business Insights and Technology (BI&T) to advance the company's data governance framework across R&D, Commercial, Medical, Manufacturing, and enabling functions. The Senior Counsel translates evolving global data and AI requirements into practical policies, controls, and guardrails that support responsible data use and AI adoption in a highly regulated life...

The Regeneron Senior Manager, Global Development Quality Assurance, is a key position in the supervising, guiding and leading for one of the Good Clinical Practice (GCP) audit programs. Responsibilities include managing direct reports while supporting the development and execution of departmental mission, vision and goals. As part of the role of people manager, you will be responsible for staff development & training and resourcing direct reports. You will create strategic partnerships and implement risk-based quality auditing activities. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & where This...

Job Title Quality Engineer This position works out of our Houston, TX 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 DAILY REQUIRED POSITION. What You’ll Work On This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within manufacturing and during product manufacturing site transfer activities. MAIN RESPONSIBILITIES Identify and implement effective process control systems to support the qualification and on-going manufacturing of products in compliance with FDA 21 CFR Part 820/ISO 13485 requirements ...

Job Title Associate Quality Engineer This position works out of our Houston, TX 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 DAILY REQUIRED POSITION. What You’ll Work On This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within manufacturing, or system/services support. MAIN RESPONSIBILITIES This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within manufacturing, or system/services support. Identify and implement effective process control systems to support the...

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...

About the role As a Quality Control Analyst II, you will execute and review routine in-process, drug substance, and stability test methods in a timely manner. You will use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower). This shift will be working from Saturday to Tuesday. How you will contribute Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal). Conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability. Own and...

About This Role As a Compliance Officer, you will uphold and promote ethical integrity within Biogen's US business. Your expertise will ensure that our business operations adhere to the highest standards of compliance and regulatory conduct. By developing and delivering comprehensive training programs, you'll be an educational pillar for both new and established employees, fostering a culture of continuous learning and compliance awareness. Your strategic insight will be pivotal in identifying and managing compliance risks. Reporting to the Lead US Compliance Officer, this role is hybrid and based in our Cambridge, MA office, with the understanding that periodic travel is...

Department - Global Regulatory Affairs and Clinical Safety - Vaccine & Infectious Disease Brief Description of Position- The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and Infectious Disease therapeutic area. Primary activities include, but are not limited to Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. Develops worldwide product regulatory strategy to optimize label...

The Patient Safety Associate Medical Director will provide medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development). This role will optimizes patient safety of Vertex products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe, through the effective and timely completion of Safety activities through the product life cycle. Key Duties and Responsibilities Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development) Responsible for the safety assessment activities of assigned products under the supervision...

United States Regulatory Strategy, Obesity and Related Conditions, Manager What you will do In this vital role you will. Amgen is seeking a United States Regulatory Lead (USRL) Manager supporting products in the Obesity and Related Conditions 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...

SENIOR ASSOCIATE REGULATORY AFFAIRS – CMC What you will do In this vital role you will facilitate product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen is searching for a Senior Associate to join the R egulatory O ptimization o f T echnical, S urveillance, and S trategic Support (ROOTS2) group within RA CMC. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and country. The RA CMC Senior Associate will interface with the Amgen...

U.S. Regulatory Strategy – Obesity and Related Conditions, Senior Manager What you will do In this vital role you will support products in the Obesity and Related Conditions Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules. This role requires demonstrated experience leading U.S. regulatory strategy and FDA interactions and may be performed within a global regulatory organization supporting U.S. regulatory responsibilities. In this product-facing role, you will develop and execute regulatory strategy in close partnership with the Global Regulatory Lead (GRL), serving as...

The Executive Director, Microbiology Quality Sterility Assurance (MQSA) is a pivotal global leadership role within BMS's Corporate Quality organization. This position brings critical expertise in sterility assurance, microbiological controls, and contamination control strategy across BMS's internal and external commercial and PD manufacturing sites — spanning pharmaceutical, biopharmaceutical, cell therapy and radiopharmaceuticals. This role is responsible for defining, owning, and governing BMS's enterprise-wide Contamination Control Strategy (CCS) as a living, risk-based framework — ensuring alignment with EU GMP Annex 1, FDA, and all applicable global regulatory standards. The Executive Director serves as the global Single Point of Contact (SPOC) for all...

We anticipate the application window for this opening will close on - 17 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...

DePuy Synthes is recruiting for a(n) Technology Mgr, Quality Systems, AI Lead located in Raritan, New Jersey, West Chester, Pennsylvania, Palm Beach Gardens, Florida, Raynham, Massachusetts, Warsaw, Indiana USA. This role plays a lead role in shaping the future of digital quality within Supply Chain Technology. This role leads the design and continuous improvement of quality systems, ensuring reliability, compliance, and scalability of technology platforms while embedding AI-driven innovation. You will directly impact product quality, operational excellence, and patient outcomes by strengthening quality management practices across systems, data, and processes. This is an exciting opportunity to influence enterprise-wide transformation at...

As Regulatory Strategist within our R&D team , you will be ready to shape the future of medicine. The race is on to speed up drug discovery and development to find answers for patients and their families, and your skills could be critical in helping our teams accelerate progress. As a key member of the Global Regulatory Team (GRT) and strategic partner to the Global Regulatory Lead (GRL), you will leverage your regulatory expertise to contribute to the definition of the global regulatory strategy and drive the execution of aligned US, EU, and/or global regulatory strategies for assigned projects, including...

Supplier Quality Engineer This position works out of our Scarborough, ME location in the Infectious Disease, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Supplier Quality Engineer will help drive supplier quality performance, continuous improvement, and risk mitigation across the supply base. Acts as a key technical contributor partnering across functions to ensure supplier capabilities meet product, regulatory, and business requirements. Leads supplier...

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...