Quality & Regulatory Jobs in Pharma & Biotech

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

As a Co-op in the MedTech (MT) Quality Systems and Digital Services organization, you will have the chance to Collaborate with teams across J&J MedTech on software projects and software governance. Support and/or perform validation activities for quality system solutions, including requirement development, validation planning, software testing, etc. Learn and apply various software development and lifecycle management techniques. Develop and contribute to training materials including procedures and knowledge articles. Promote digital culture and capabilities across J&J medical devices. Strengthen communication and leadership skills. Work with a diverse team of quality engineers, data scientists, app developers, etc. Take advantage of training...

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

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....

The Lead Digital Health Quality Engineer will serve as representative on cross-functional SaMD and Digital Health Software product development teams, driving design controls, DHF management, software validation, and risk management (ISO 14971) throughout the software life cycle. This role will Author, review, and approve QMS and project documentation — including risk management files — to ensure products are developed, tested, and released in compliance with applicable SDLC procedure and/or medical device regulations. This role will lead quality process improvement initiatives, support regulatory characterization and audit, and contribute to cybersecurity quality activities, applying IEC 62304 and strong technical writing and cross-functional...

Purpose 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...

Johnson & Johnson is searching for a Senior Quality Engineer to join our DePuy Synthes Quality organization located in Palm Beach Gardens, FL. The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. Our rapidly growing Velys Enabling Tech Operation is in need of a Senior Quality Engineer who provides overall quality assurance...

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...

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 Quality Systems Specialist supports the maintenance and continuous improvement of the quality management system to ensure compliance with applicable internal...

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

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 Quality Engineer I supports engineering activities associated with product, process maintenance, equipment including evaluation and implementation of changes to materials,...

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

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 Quality Engineer I supports in quality and supplier engineering activities associated with product, process maintenance, equipment including evaluation and implementation...

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 Quality Engineer provides quality engineering leadership for machining and selected secondary operations, including anodizing and final pack. This role...

Position Responsibilities We are seeking a Growth and Improvement-minded Data Services Specialist in Quality Control that can help drive our Strategic Operating Priorities. Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business) Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is...

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 Manager, Quality Control at Gilead you will manage the Quality Control Chemistry or Microbiology laboratory operation, ensuring laboratory processes provide...

Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You'll Work On Upholds Division approval requirements to supplier and monitors feedback per project timelines. Analyzes incoming material defects. Generates and maintains incoming inspection procedures. Trains inspectors to these procedures. Owner of Non-Conforming Material Reports (NCMRs) issued to supplier for nonconforming supplied material and works with the supplier on the investigation and root cause analysis. Generate test protocols,...

Senior Associate, United States Regulatory Professional – Obesity and Related Conditions What you will do Amgen is seeking a United States Regulatory Professional (USRP) supporting products in the Obesity and Related Conditions Therapeutic Area (TA). Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of Amgen molecules. In this product-facing role, you will support the creation and submission of regulatory documents under the supervision of a more experienced regulatory lead. The USRP provides operational support for U.S. regulatory execution by coordinating submission deliverables, maintaining compliant documentation, and partnering cross-functionally to...

The Compliance/Customs Lead serves as the primary technical subject matter expert for all import/export, transport, and trade compliance activities at the site level. This role is responsible for ensuring that all logistics and customs operations are executed in full compliance with applicable regulations, corporate standards, and international trade requirements. We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. About...

The Compliance/Customs Lead serves as the primary technical subject matter expert for all import/export, transport, and trade compliance activities at the site level. This role is responsible for ensuring that all logistics and customs operations are executed in full compliance with applicable regulations, corporate standards, and international trade requirements. We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. About...

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

DePuy Synthes is recruiting for a Director, Analytics & Compliance, located in Raynham, MA, Raritan, NJ, and West Chester, PA The Director, Analytics & Compliance will own the end-to-end strategy, operating model, and measurable outcomes for analytics-enabled compliance, risk monitoring, and enterprise financial reporting across DePuy Synthes. This leader will translate business, Finance, Legal, Compliance, Quality, IT, and operational priorities into scalable analytics products, SAP-fed financial reporting solutions, data controls, AI-enabled capabilities, and action-oriented monitoring processes that improve decision quality, risk coverage, productivity, auditability, and business performance. The role is accountable for moving analytics beyond reporting by ensuring that insights,...

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 Sr. Quality Engineer supports quality assurance activities within a regulated manufacturing environment, ensuring products and processes meet applicable quality, regulatory,...

We anticipate the application window for this opening will close on - 12 Sep 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...

Responsible for supporting the Product Safety Lead (PST) in ensuring safety in one or more products to through surveillance, signal detection, validation and assessment. Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance Safety surveillance for pharmaceutical / biological / drug –device combined products Contribute to the authorship of key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents Analyze and interpret...

The Sarbanes Oxley (SOX) Risk Architect & Compliance Lead role is accountable for facilitation of IT risk management processes. Collaborates cross-functionally to help mature and execute the IT Risk Security and Compliance processes which include governance, risk assessment, risk analysis, risk metrics, risk reporting, supplier monitoring, internal / external audit support, and technology enablement. Provides leadership for the creation of a SOX Compliance Strategy, project execution and improvement initiatives for IT. Creates strategies and processes related to all areas of Governance, Risk Management and Compliance. May coordinates the efforts of several groups to ensure compliance with other federal and industry...

Director, Corporate Compliance The Director, Corporate Compliance will serve as a strategic compliance partner to key business functions across Natera, with particular focus on our rapidly growing Oncology business. Reporting to the Sr. Director of Corporate Compliance, this individual will provide practical, solutions-oriented compliance guidance to business leaders while helping the organization identify, assess, and proactively manage healthcare compliance risk. This role will partner closely with Oncology Sales, Marketing, Medical and other cross-functional stakeholders and will provide compliance guidance related to commercial activities, clinical trials, pharmaceutical partnerships, companion diagnostics, healthcare professional engagements, and other evolving business initiatives. The ideal...

We are seeking an Associate Director, Quality Control to lead the Beam Massachusetts Quality Control team in delivering compliant, scientifically sound, and timely GMP testing while maintaining a continuous state of laboratory and inspection readiness. This on-site role will provide site-based QC leadership for routine GMP testing operations supporting Beam’s clinical and late-stage programs, and will help support the team’s transition from a clinical-stage QC group to a late-stage, commercial QC operation. The successful candidate will be responsible for leading a team performing release, stability, method qualification/validation, and method transfer testing while ensuring that analytical methods, laboratory equipment, LIMS/LES builds,...

Are you a highly skilled professional, interested in Quality Excellence, driven by a passion for innovation and a desire to make a tangible impact? At Roche, our commitment to quality in Pharma Development is unwavering. We deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society. The Opportunity As Quality Excellence Lead in our Quality Excellence Infrastructure team, you will Shape the global ecosystem Drive, maintain, and continuously elevate our Quality Infrastructure strategies to deliver organizational efficiencies, scalability, and measurable productivity gains. Unlock data-driven decision-making Manage critical Quality data to maintain...

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 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...

Johnson and Johnson Visioncare is recruiting for a Staff Engineer, External Manufacturing and Supplier Quality located in Jacksonville, Florida. About Vision Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life....

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 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....

MAIN PURPOSE OF THE ROLE QA Compliance is responsible for maintaining and strengthening the Quality management system so that Abbott Laboratories meets the standard. The Compliance team manages the documentation system, systems for food safety and laboratory quality, internal and external audit programs, pest control and sanitation program and stakeholders for governmental law and legislation. The Compliance Coordinator develops and keeps all Quality management system. 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...

The Opportunity The Logistics & Distribution Quality Leader will lead and direct efforts as it relates to quality compliance and controls across international and domestic product movements, warehouse operations and materials management. They will be responsible for identifying, developing, implementing, and maintaining an all-encompassing quality compliance program that aligns with our enterprise QMS and ensures our facilities and processes are audit ready. They will be responsible for representing Supply Chain, Logistics, and Warehouse in all internal and external Quality Audits. What You’ll Work On Include, but are not limited to, the following Oversee the Change Control processes, coordinate activities across...

Incoming Quality Technician II / CMM Programmer The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health. Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics. Our location in Irving, TX, currently has an opportunity for Incoming Quality Technician II / CMM Programmer. Working under minimal supervision, the IQA Technician II performs...

The Opportunity The Sr. Warehouse Quality & Document Specialist will lead, support, and direct efforts as it relates to quality compliance and controls across international and domestic product movements, warehouse operations and materials management. They will be responsible for supporting the development, implementation, and maintenance of an all-encompassing quality compliance program that aligns with our enterprise QMS and ensures audit readiness at all Abott’s locations. They will support the optimization of Quality Operations across all warehouses, enterprise-wide. What You’ll Work On Include, but are not limited to, the following Oversee Quality Documentation, coordinate activities across departments, and monitor change controls...

The mission of Quality Assurance is to safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high-quality data and clinical supplies. Working in the Finished Goods Platform TPQM (Third Party Quality Management) department within our Research & Development Division. You will be responsible for serving as the quality representative for and providing quality oversight of contractors performing various GMP activities supporting the production of clinical supplies, on behalf of our Company Key responsibilities include Act as a Lead Quality Liaison...

The Quality Control Microbiology Manager is responsible for planning and prioritizing resource allocation in Upper Merion Biopharma quality control microbiology laboratory to meet testing requirements for product release, raw material, utility, in-process, etc. Oversee the operation of QC Microbiology area which includes bioburden, endotoxin, and other microbiology testing areas. Responsible for managing training of quality control analysts, transferring assays from the development group, qualifying, and validating new assays and implementing assays to be used for quality control purposes to support manufacturing and marketing of the product. Other functions conduct laboratory investigations related to product testing, compile reports in support of...

This is what you will do The Patient Experience Team (PEX) fuels Alexion AstraZeneca Rare Disease ’s corporate priorities by ensuring the patient voice guides every stage of our work. Increasingly global regulators, and decision makers such as HTA bodies and payors recognize the value of lived patient experience data (PED) to inform therapeutic development regulatory decision-making in line with guidance including patient-focused drug development , while supporting coverage and access decisions that can impro ve real-world outcomes . The Patient Experience and Regulatory Engagement role serves as a strategic bridge between Global Medical Affairs, R&D, Global Marketing & Market...

The Global Patient Safety Individual Case Safety Report (ICSR) Manager is responsible for performing Individual Case Safety Report (ICSR) processing activities, including case book-in, triage, case entry (structured field data-entry, event coding, narrative writing, and pursuit of follow-up information), finalization and reporting. The Global Patient Safety ICSR Manager works with a high degree of independence and is proficient at troubleshooting problems to create and execute improved internal procedures, and to ensure compliance with applicable regulatory requirements. This individual ensures that all work performed is in accordance with relevant regulatory guidelines. By virtue of their experience, the Global Patient Safety ICSR...

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

We anticipate the application window for this opening will close on - 4 Sep 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 Neuroscience is focused on transforming care...

We anticipate the application window for this opening will close on - 2 Sep 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 Responsibilities may include the following and other...

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

Job Title Quality Assurance Manager We are seeking a Quality Assurance Manager for Abbott Vascular in our Temecula, CA site. This is an onsite role. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. Job Summary This position provides leadership and guidance for the department, has responsibility for recruiting, developing and retaining talented employees, supports company goals and objectives, and communicates key information to staff members and senior management. What You’ll Work On Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written...

This hybrid role could be based at any of AbbVie's location in the US such as North Chicago, IL Cambridge, MA, Worcester, MA Irvine, CA, San Francisco, CA or Florham, NJ Purpose As an independent RDQA Organization, our commitment is to drive quality excellence as a strategic advantage across all stages of discovery and development for the lifecycle of the product to achieve product realization and to accelerate access to innovative therapies for our patients. AbbVie’s R&D global trial footprint has been expanding due to growth in the pipeline and the complexity of global development resulting in an overall increase...

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered...

The Audit & Compliance Manager manages and coordinates audit, inspection, and compliance activities across Data, Technology & Engineering (DTE) and business functions. This role serves as the primary liaison between operational teams and auditors, ensuring timely preparation, execution, response, and remediation of Internal Audits, GxP audits, and regulatory inspections. The role partners closely with Internal Audit, Quality Assurance, SOX PMO, system owners, and business teams to ensure audit commitments are met and compliance obligations are fulfilled. General Responsibilities Serve as the primary DTE point of contact for IT-related audit, inspection, and compliance requests across GxP, Internal Audit, and operational audit...

The Clinical and Regulatory Strategic Communications (CRSC) department within Global Clinical Trial Operations (GCTO) creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials. The Associate Director of Disclosure Quality and Operations overseas and leads the preparation, quality control, tracking, and submission of clinical and regulatory documents and transparency deliverables, while coordinating with stakeholders to ensure compliance, accuracy, and timely completion of regulated content. Key responsibilities may...

The successful candidate will contribute to the advancement of our product pipeline by performing QA batch record review, label review and verifications, document archival of records, and other assigned tasks. You will also be exp ecte d to in dependently coordinate and manage timelines for batch record reviews. You will be expected to provide support for both the Santa Mo nica, CA and Tarzana, CA sites as needed. Responsibilities include, but are not limited to Reviews routine manufacturing batch documentation and quality control data for in-process and finished product to support disposition and lot closure. Review routine material release documentation...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Senior Director, Compliance Policy & Education is a member of the Compliance & Ethics Leadership Team responsible for three enterprise...

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,...

We anticipate the application window for this opening will close on - 11 Sep 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 - 5 Sep 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 ...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Johnson & Johnson MedTech’s Robotics & Digital Surgery (RAD) business is seeking an accomplished Director Software Quality Engineering & Cybersecurity for the OTTAVA Robotic Platform to be located at Santa Clara, CA. The Director leads the quality engineering strategy and execution for software-enabled medical technologies across the OTTAVA robotic surgical platform. This leader oversees software quality engineering activities supporting software in medical...

J&J MedTech is recruiting for a Senior Quality Engineer located in Cincinnati, OH. The role of a Senior Quality Engineer at J&J MedTech is to apply the principles of engineering, mathematics, statistics, organizational excellence, and risk management to help the company achieve two major objectives in support of the J&J Credo Meet and exceed the expectations of our customers Achieve and maintain compliance with regulatory expectations The Senior Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products, and ensures compliance to good manufacturing practices, international...

Johnson & Johnson is currently seeking One Quality Assurance Specialist II to join our QA team located in Raritan, NJ! This position will have the following shift Wednesday- Saturday or Sunday- Wednesday 730-6pm with a preference for the Wednesday- Saturday shift flexibility. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health...

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 An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Quality Control Analyst I . Purpose Conducts analytical testing of stability samples according to testing schedules...

This position works out of our Lake Forest, IL location in the Core Lab , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Principal Professional Quality is responsible for the implementation and management of the Quality Assurance program for the Core Dx Digital Health Solution products. The role includes oversight of design and development quality processes, post-market support, and continuous improvement initiatives. The Principle...

Job Title Quality Engineer We currently have an opening for a Quality Engineer for the Vascular division. This role is located at our Temecula, CA location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. 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. MAIN RESPONSIBILITIES Provides hands-on quality engineering support for warehouse and distribution operations within a regulated medical device environment. This role ensures compliance with FDA Quality System Regulation (21 CFR...

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 QA Supervisor oversees day-to-day quality assurance operations, provides leadership and coaching to QA team members, and ensures consistent application...

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

Salesforce SOX Compliance & Release Manager (Hybrid in South San Francisco) Summary The Salesforce SOX Compliance & Release Manager will maintain and execute our Sarbanes-Oxley (SOX) and Information Technology General Controls (ITGC) frameworks across our enterprise Salesforce environment. This role will handle day-to-day audit support, access controls, and release coordination, and serve as an operational point of contact for Internal Audit, external auditors (EY), and cross-functional teams to ensure that change management policies and user lifecycle processes are consistently executed and documented. Core Responsibilities SOX & ITGC Operational Compliance Audit Support & Evidence Gathering Assist in pulling walkthrough samples, change...

We are searching for the best talent for Complaint Quality Approver to join our External Quality team located in Horsham, PA; Titusville, NJ; or Raritan, NJ. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) Brazil - Requisition Number R-095747 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single...

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered...

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...

Join us as a Director Quality Assurance , where you will lead and direct the Site Quality Assurance Operations at our Cell Therapy 9950 MCD Rockville manufacturing site. This role offers an opportunity to develop strategic and operational plans, lead high-level projects, and define innovative solutions within complex areas of the business. You will be working on diversified tasks with a global team, providing you with exposure to new ways of thinking and helping us grow collectively and as individuals. What you will do Lead the new Quality Assurance team at the Commercial Cell Therapy Facility, supporting facility start-up and...

The Patient Safety Senior Medical Director will provide leadership for all safety and risk management activities for assigned products, pre- and/or post-approval. This role will lead Risk Management activities, pre-, peri- and post-approval (as applicable) for assigned compound(s) and will provide relatively autonomous leadership of periodic (aggregate) safety report, signaling, labelling and DST activities for assigned compounds, as well as participate in individual case medical review. This role will lead representation, as safety lead, on clinical teams/programs, regulatory filings and submissions and other intra and/or inter-departmental activities and initiatives, including process/SOP development, audits and inspections. Key Duties and Responsibilities Represents...

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....

We are searching for the best talent for a Manager, ERP WMS Leader, Technology Quality. Purpose Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with J&J’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with closing compliance gaps related to audits and inspections. The Manager, ERP WMS Leader, Technology Quality is...

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....

* This is not an active open requisition. We are building a candidate slate for a future opening.* Job Title Software Design Quality Engineer We currently have an opening for a Software Design Quality Engineer for the Vascular division. This role is located at our Westford, MA location. This is a fully onsite role. 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. MAIN RESPONSIBILITIES Lead, execute and support on-time...

The Global Trade Compliance department's primary function is to provide corporate-wide leadership and direction for the development, administration and enforcement of policies and procedures related to Abbott's global trade compliance program. The Sr. Analyst's primary responsibility is to support and manage the post-entry aspects of U.S. Customs and Border Protection matters, including protest, prior disclosures, post-summary corrections, liquidated damages/bill review, duty recovery, and customs compliance investigations. This role partners closely with internal business teams, customs brokers, and external legal advisors to identify compliance issues, assess risk, prepare corrective actions, and ensure timely and accurate submissions to government agencies. The Senior...

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. Our FreeStyle Libre continuous glucose monitors has revolutionized the way roughly 6 million people worldwide manage their diabetes. This is an exciting opportunity with responsibilities for US submissions for new product introductions, which include breakthrough advancement in diabetes management and digital health technology solutions to address the...

The role of the SAP Manufacturing Manager is to lead a team of SAP analysts focused on the manufacturing, quality and planning functions within the Medical Devices SAP environment (SAP-MD). The team is responsible for analyzing business and technical processes, documenting business requirements, defining changes to business processes, configuration, testing and implementation of changes to the enterprise-wide business systems. This person serves as the primary point of coordination and communication for enhancements and projects being planned for the manufacturing, quality and planning area of SAP, and coordinates with business and technology teams to support and test integrated business systems to...

The Associate Director, Device Quality Assurance within Device Quality & Regulatory (DQ&R) is responsible for providing quality oversight of our Company's Device Network. This specific role is responsible for providing quality support for device assembly and packaging operations at our Company's Wilson, NC site and will be based on-site at Wilson. This role will serve as the primary interface between our Research & Development DQ&R and our Company's Wilson, NC site for the following aspects 1. Serve as on-site quality oversight for medical device and combination product operations which require above-site support Accountable for on-site Device Quality and Regulatory support...

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. Our Quality Assurance team works closely with Manufacturing Operations to ensure our products are made safely and to the highest...

Our Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and robust strategies for registration enabled by engagement with global health authorities. We work across functions and geographies to advance development programs and maintain licensure for the General Medicine portfolio worldwide. We seek a leader with a growth mindset, demonstrated by intellectual curiosity and the ability to navigate complex regulatory challenges with rigor and professionalism. Position The Executive Director, Regulatory Affairs Liaison reports to the Vice President (VP), General Medicine, and is accountable for defining and executing global regulatory strategy for assigned ophthalmology...

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

DePuy Synthes is recruiting for position, located in MA Raynham , FL Palm Beach Gardens, ,IN Warsaw , NJ Raritan . Alternate Hybrid locations may be considered at Leeds ,UK or Loughbeg, Ringaskiddy; Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) MA Raynham Requisition Number R-094617 St. Anthony's Road, Leeds, UK - Requisition Number R-095611 Loughbeg, Ringaskiddy -...

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with...

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with...

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with...

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with...

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

Job Summary The QMS Global Quality Compliance Director reports into the Associate Vice President, Global QMS and is a senior quality governance and compliance role responsible for driving strategy, execution, and oversight of key quality compliance activities across the Operating Units (OpUs) and associated sites. This role sits on the QMS Leadership team and provides leadership for global quality governance forums, including GPO, GVO, and GBO Quality Councils. This role serves as a critical connector between site quality teams, OpU leadership, QMS Topic Leads, and global quality governance bodies and Divisional Quality Council (DQC). The Global Quality Compliance Director is...

As part of the Global Clinical Supplies (GCS) Organization, the Sr. Specialist, Master Data Quality Management is responsible for driving data quality, governance, stewardship, and operational excellence across critical master data domains supporting Global Clinical Supply Operations (GCSO). This role helps ensure that master data is accurate, complete, compliant, and fit-for-purpose to support planning, manufacturing, packaging, distribution, regulatory compliance, and business decision-making. The individual partners with Data Owners, Process Stewards, IT, Business Operations, and Analytics teams to establish data quality controls, monitor performance through dashboards and Key Performance Indicators (KPIs), facilitate remediation, and support continuous improvement initiatives. The role is...

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....

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

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

We anticipate the application window for this opening will close on - 9 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we bring bold ideas forward...

We anticipate the application window for this opening will close on - 8 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life A career at Medtronic is like no...

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. What You’ll Work On Preparation of regulatory submissions for Electrophysiology devices to achieve departmental and organizational objectives. Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities. Acts as...

This position works out of our Madison, WI location in the Cancer Diagnostic 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. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often...

This position works out of our corporate Abbott Park, Illinois location. The Abbott Quality and Regulatory (AQR) Global compliance audit function is a corporate program which conducts audits of Quality Systems across all of Abbotts Manufacturing sites. Product quality and/or regulatory problems can negatively affect consumer health and safety, Abbott’s worldwide image, performance of Abbott earnings and market share and customer confidence and loyalty. The role has a broad responsibility that has significant impact throughout AQR and all divisions. The position is responsible for ensuring executive management is aware of compliance business risks and regulatory requirements. We are seeking an...

Our location in Temecula, CA, currently has an onsite opportunity for a Quality Engineer. 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 Provide Process/Quality Engineering support on the manufacturing line, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. What You’ll Work On Support project planning and perform assessments and mitigations...

Schedule- 8am-430pm. MAJOR DUTIES AND RESPONSIBILITIES 1. Initiates, documents, and supports deviation records and supplemental reports to investigate atypical events within the Engineering organization, including leading investigations and deviation supplementals as required. 2. Acknowledge and conducts investigations and deviations supplementals for facilities, utilities and/or maintenance deviations and supplementals. Accountable for Corrective Actions and Preventive Actions (CAPA) or actions related to regulatory observations, internal audits or deviations within the engineering department. 3. Supports readiness of the facility for regulatory inspection. Represents the maintenance department during regulatory agency inspections such as FDA / EMEA and/or during internal company audits. 4. Support maintenance...

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,...

Do you have experience transforming digital processes with AI and automation, supported by knowledge of Regulatory Affairs strategy or policy? If you want to work on innovative projects of high importance for our Respiratory and Immunology (R&I) portfolio, then AstraZeneca is the place for you. Our aspiration is to be pioneers in science, leading in our disease areas to truly transform patient outcomes. This means our people are here to win, and we give you a breadth of opportunities to be curious and do cutting edge, unique work that has significant impact on science, medicines, and patients. The Global Regulatory...

Johnson & Johnson is currently recruiting for a Manager Supplier Quality! This position will be located in Athens, GA 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 This role ensures business, quality and compliance goals adhere to Johnson and Johnson (J&J) policies, enterprise standards and government-issued...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer to be based in Horsham, PA. Purpose The Senior Manager, Health Care Compliance Officer serves as a strategic healthcare compliance partner to Johnson & Johnson Innovative Medicine teams, enabling compliant growth through risk-based, principles-driven guidance and decision support. This role operates within a dynamic and highly regulated environment, translating evolving legal, regulatory, and policy requirements into clear, practical, and actionable guidance that supports both business objectives and ethical standards. Consistent with the Innovative Medicine compliance strategy, this position helps advance the evolution from a rules-based...

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...

CIG Senior Specialist Quality Assurance In this role, you will lead cross-functional teams in the execution of complaint investigations, ensuring activities are completed in a timely, compliant, and cost-effective manner. You will monitor team performance through key performance indicators (KPIs), identify opportunities for continuous improvement, and drive process enhancements to support operational excellence. Responsibilities include coaching and developing team members through training, performance management, and succession planning initiatives. As a Subject Matter Expert (SME) for complaint investigations, you will play a key role in maintaining audit readiness, supporting inspections, and leading audit tours. You will also analyze complaint data...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a “ Principal Engineer, Vendor Compliance & Asset Performance” to join our team in Raritan, NJ. Summary The Principal Engineer, Asset Management & Vendor Compliance Strategy, provides technical leadership for the...

The Polio, Pertussis and Haemophilus influenzae type b (Hib) or PPH franchise is dedicated to safeguarding health through vaccines that protect against Polio, Pertussis, Tetanus, Hib, Diphtheria, and Hepatitis B. The RA PPH team is responsible for developing and executing strategic regulatory initiatives that maintain market leadership, support continuous product improvements, and ensure sustained compliance with evolving global regulations. The team serves as the critical interface between R&D, manufacturing, and Health Authorities to navigate regulatory requirements, manage lifecycle strategies, and drive market access for the PPH vaccine portfolio This position requires agility to work transversally across the PPH Franchise and...

Quality Manager This position works out of our Westfield, IN location in the Structural Heart division. 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. The Quality Manager is accountable for the Quality Operations Organization and leads a team of Quality supervisors/technicians/inspectors/specialists to support Manufacturing, Supplier Development, New Product Development, Distribution/Warehouse Value Added Services, and Quality Systems. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements. What You'll Work On Implements a staffing plan by...

The function of a Director, Regulatory Affairs is to combine scientific, regulatory, and business expertise to ensure that products developed, manufactured, or distributed comply with applicable regulatory requirements. Additionally, the Director may develop and supervise regulatory professionals. This role has division-level influence and is generally recognized as a key opinion leader and expert resource, both within Abbott and externally. The Director may influence evolving regulations and guidance, interface with regulatory agencies and trade associations, and provide executive management with regulatory metrics, insights, and strategic recommendations. WHAT YOU’LL WORK ON Responsible for compliance with applicable Corporate and Divisional policies and procedures....

We anticipate the application window for this opening will close on - 2 Sep 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 Quality Engineer II will support...

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

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 Education Bachelor’s degree in engineering required. millions of people worldwide. The Sr. Quality Engineer supports quality assurance activities within a regulated manufacturing...

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 Manager, Technology Regulatory Compliance, is responsible for leading compliance activities related to technical and regulatory requirements across the organization in support of product and non-products systems. This role ensures that technical processes, documentation, and system implementations align with applicable regulatory standards, quality system requirements, and internal policies. The position plays a critical role in managing compliance risk, conducting audits and assessments, supporting audit inspection readiness, and enabling compliant execution of technical initiatives...

Johnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, Quality Asset Management within Advanced Therapies to be located in Titusville, NJ; Raritan, NJ; Malvern, PA or Spring House, PA. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) Belgium - Requisition Number R-095461 Switzerland – Requisition Number R-095456 Remember,...

Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies. You will manage the commercial regulatory strategy and execution of such for multiple high-volume and/or otherwise complex brands...

About This Role As an Associate II, Quality Control, you will serve as a key member of the Quality Control Raw Materials/Sample Control team at the Biogen RTP Pharma site. In this role, you will be responsible for sampling and inspecting raw materials, as well as managing manufacturing, retain, and stability samples. You will ensure the proper handling, documentation, storage, distribution, and disposal of materials and samples in compliance with GMP requirements. Additionally, you will support laboratory operations through LIMS management, sample logistics, investigations, and other operational support activities. Working both independently and collaboratively, you will play an important role...

Quality Compliance Senior Manager What you will do Serve as a GCP Subject Matter Expert, providing independent and objective quality advice in support of clinical trial activities and in line with current best practice. Provide quality oversight for Amgen programs for all stages of products in clinical development. Plan, conduct and report out on risk-based GCP audits (investigator site audits, affiliate audits, service provider audits, and study level audits) or support outsourced audits. Manage/support regulatory inspections and provide guidance and feedback on responses to health authorities, including root cause and CAPA plans. Provide quality oversight for the Risk Assessment...

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

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

POSITION SUMMARY Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. Our mission is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy. As QA Manager, Scientific Operations, you will own quality management across the team, spanning the Sample Management and Sample Operations functions. Working in close partnership with the Natera QA team, you will be responsible...

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered...

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...

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...

USE YOUR POWER FOR PURPOSE Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action. WHAT YOU WILL ACHIEVE Working with Pfizer’s dynamic maintenance/engineering team, you will play a critical part in managing the maintenance and reliability engineering activities involving the redesign, maintenance, and repair of utilities systems, buildings, and production/non-production...

We anticipate the application window for this opening will close on - 8 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we bring bold ideas forward...

We 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 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 the burden...

Join Abbott’s Corporate Audit team as a Senior Auditor, Global Compliance Audit where you will gain knowledge ’s four global businesses while learning valuable soft skills interacting with senior leadership. Corporate Audit is a rotational program, where after 2 to 3 years, the position leads to potential global career opportunities in finance, compliance, legal or sales/marketing roles supporting corporate or a division. Corporate Audit’s objective is to evaluate and improve effectiveness of risk management, internal control, and governance processes, and develop a pool of managerial talent for the company. This position may be located in the following Abbott locations Willis...

The Operations Quality Senior Systems Engineer will investigate, identify, and implement state-of-the-art technology platforms, focusing on Quality Management Systems (QMS), Learning Management Systems (LMS), Document Management Systems (DMS), Artwork Management Systems, and advanced Data & Analytics solutions leveraging AI. This role acts as a senior technical leader to integrate technical advances into business solutions that drive productivity, compliance, and operational excellence across Quality and Operations. Responsibilities Lead the design, operation, and optimization of large-scale cloud services (AWS) supporting QMS, LMS, DMS, artwork, and data analytics platforms. Troubleshoot complex system issues and tune performance for enterprise-scale applications. Architect and develop robust,...

This role serves to provide leadership at the site Quality Operations level to support strategic initiatives, product filings, continuous improvement, and management of the site Quality System. Quality excellence is a key strategic driver to ensure regulatory standards are understood and adhered to at the site operations level. This position holder will have responsibility for oversight of the Compliance and Regulatory activities for the site and ensure successful inspection outcomes and delivery of high quality, compliant products for the patients that we serve. Responsibilities Oversight of Compliance and Regulatory activities at the site operations level, specifically leadership of a team...

Technical expert that will independently identify, engineer, and optimize new data, software, or technology solutions that address critical business needs. Focus areas will include Laboratory Information Management Systems (LIMS), Automated Lab Testing utilizing software orchestration solutions, and advanced Data and Analytics solutions leveraging AI. This role acts as a technical leader to integrate technical advances into business solutions that drive productivity, compliance, and operational excellence across Quality and Operations. Responsibilities Lead the design, operation, and optimization of cloud services supporting LIMS, Automated Lab Testing solution (e.g. Scitara, Ignition, LabX), and data analytics platforms. Troubleshoot complex system issues and tune performance...

Technical expert that will independently identify, engineer, and optimize new data, software, or technology solutions that address critical business needs. Focus areas will include Laboratory Information Management Systems (LIMS), Automated Lab Testing utilizing software orchestration solutions, and advanced Data and Analytics solutions leveraging AI. This role acts as a technical leader to integrate technical advances into business solutions that drive productivity, compliance, and operational excellence across Quality and Operations. Responsibilities Lead the design, operation, and optimization of cloud services supporting LIMS, Automated Lab Testing solution (e.g. Scitara, Ignition, LabX), and data analytics platforms. Troubleshoot complex system issues and tune performance...

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...

Senior Director, Quality Are you ready to pioneer a modern Quality mindset that safeguards patients while accelerating delivery? As Senior Director, Quality for our Mount Vernon site, you will lead the end-to-end Quality function that releases every batch, from raw materials to finished product, ensuring cGMP compliance and reliable, quality supply to patients. In this high-impact role, you will set the vision and standards for a functionally independent Quality unit, steer regulatory and compliance strategy, and partner closely with manufacturing and supply leaders to deliver safe, effective medicines with confidence. You will coach and empower a large, multi-disciplinary Quality team,...

We anticipate the application window for this opening will close on - 18 Sep 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 Design Quality Engineer, supporting Released...

This position works out of our Tbilisi, Georgia location in the Established Pharmaceuticals business. As the Administrative and regulatory affairs assistant, you’ll have the chance to provide assistance and support to the country manager and other members of the company by handling day to day administrative tasks and contributing to the department projects and regulatory affairs projects. What You’ll Do Provide administrative services for all members of the company. Sending correspondence Preparing orders Office support (stationery, paper, water, tea, coffee, milk, organization of equipment repair , refilling cartridges, organization of office cleaning , minor repairs) ...

The Professional Education Compliance Lead is based out of Austin, TX position within the Cardiac Rhythm Management Division. This is a fully onsite role. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats. The Professional Education Compliance Lead is responsible for overseeing all compliance aspects of professional education programs involving physician engagement and payment. This role ensures adherence to U.S. and global regulatory requirements and internal policies, and serves as a key partner to the Office of Ethics and Compliance, Legal, Finance,...

As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including generative AI technologies designed to help millions of patients in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Prior experience working with software development teams, diabetes management devices (e.g. insulin dosing algorithms), and artificial intelligence/machine learning technologies is preferred. This role will also be...

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,...

About This Role As a QA Associate III, you will apply strong knowledge of cGMP requirements, Biogen Quality Systems, internal procedures and your primary quality discipline to support compliant manufacturing operations. You will review and approve documentation that supports batch and cell bank disposition, assess product acceptability for continued processing or distribution, and provide timely quality direction on the manufacturing floor. You will partner across Quality, Manufacturing and PO&T to identify and resolve quality and compliance concerns, support inspection readiness and advance new product introduction technology transfers and restart programs. You will also provide technical writing and investigation support, including...

In GBS we dare to change the way we work—being brave, resilient, and focused on simplifying how we deliver value. Through our global scale and diverse services, we drive outcomes with innovation and expertise. This requires a team that sees no boundaries, collaborates across functions, challenges the norm, and feels empowered, motivated, and engaged. The Senior Director, Compliance and Legal Services will lead the global build-out and maturation of a cohesive service portfolio spanning Compliance, Privacy, Legal Operations, and eDiscovery within GBS. Reporting to the Head of GBS Operations & Enabling Functions Services, this role supports strategy build, is the...

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 product supply. We need...

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

The Manager, Regulatory Affairs Submission Management , manages high impact, 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. The Manager is recognized as a discipline expert and resource in regulatory affairs submission management. Responsibilities Independently manages high impact (with respect to internal visibility, risk, complexity and criticality)submission projects to ensure...

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered...

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 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 the burden...

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 Director, Quality Control (QC Head) at Gilead, you will be responsible for providing strategic leadership and end-to-end oversight of...

Director, Global Supplier Quality Management Program Position Impact The Director, Global Supplier Quality Management Program serves as the Global Process Owner (GPO) for Supplier Quality Management, providing enterprise leadership and subject matter expertise for the strategy, governance, processes, systems, quality documents, and metrics of the supplier quality program across the end-to-end supplier lifecycle. This role is accountable for building and advancing a globally harmonized, risk-based, and customer-focused supplier quality program in partnership with internal quality functions at Gilead sites that strengthens stakeholder partnerships, drives consistent and scalable ways of working, and enhances quality, compliance, supply continuity, and operational performance across...

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Key Responsibilities Lead analytical quality oversight for external QC testing laboratories, stability programs, analytical methods, and related GMP analytical operations, ensuring activities, investigations, documentation, and quality decisions are scientifically sound, risk-based, and compliant with applicable...

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

We anticipate the application window for this opening will close on - 18 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Medtronic, a global leader in medical...

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

Are you ready to transform Regulatory Intelligence into actionable insights for product teams? Do you want to work on innovative projects of high importance for our Respiratory and Immunology portfolio? Join us at AstraZeneca, where we are investing in internal capabilities to discover and accelerate the delivery of next-generation respiratory and immunology modalities for patients. As part of the Respiratory & Immunology (R&I) Regulatory Affairs team, you will play a crucial role in bringing these transformative therapies from the lab to life. Summary of Role We have a terrific opportunity for you to join our team within R&I Regulatory Affairs...

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...

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered...

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 supply. We need the...

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 Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, North America Regulatory Liaison. This position is a hybrid role and will be located in Spring House, PA; Titusville, NJ; or Raritan, NJ. The Senior Manager, North...

The Senior Quality Systems Specialist – Data Integrity and Risk Management proactively contributes to risk identification, assessment, mitigation, governance, and reporting. Ensures communication and reporting efforts follow global and local requirements to produce value-added, actionable risk analytics and governance information. Oversees the local risk assessment periodic review program and ensures site adherence to periodic review schedules. Manages the local risk register and maintains active involvement in reporting out and up to the platform and risk management Community of Practice forums. Assists in the es and implementation of Risk Management Systems designed to identify, eliminate or reduce, and insure against potential...

The Senior Specialist, QA 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. 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 reports, including but not limited to risk assessments and deviation system monitoring reports, to support the...

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. The Associate Director Promotional Regulatory Affairs will work with a with a cross-functional review team and provide regulatory guidance and risk assessment to help business teams develop and deliver initiatives that are intended to comply with applicable laws, rules and regulations governing the advertising and promotion of pharmaceutical products in the US. Lead review and adjudication of promotional materials as are required through the AstraZeneca Approval Process (AZAP). Represent AstraZeneca to regulatory authorities for assigned...

Are you ready to steer global CMC strategy for cell and gene therapies that redefine what’s possible for patients? This role positions you at the center of breakthrough programs, where your regulatory leadership translates pioneering science into high-quality submissions and decisive health authority interactions that accelerate access for people who need it most. Based in Santa Monica, CA or Gaithersburg, MD, you will shape end-to-end CMC regulatory pathways across development stages, partnering closely with technical, clinical, and quality leaders. How will you apply your expertise to anticipate risk, set clear direction, and drive rapid, global approvals for a growing pipeline?...

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...

Manager Quality Assurance – US Distribution Quality Our location in Columbus, OH currently has an opportunity for a Manager Quality Assurance - US Distribution Quality in our Nutrition Division. What You’ll Work On Oversee (6) Distribution Quality Assurance (QA) Direct Reports + (2) Indirect Reports Implement quality standards and manage ongoing compliance for US Distribution. Provide Quality Leadership to US Third-Party and Abbott-Managed Warehouses Site Qualification and Audit Management - Lead evaluation/startup of new third-party warehouses and approval of respective warehouse quality agreements Monitor Ongoing Compliance Elevations - Audit observations, transportation or distribution events, temperature excursions, applicable registrations,...

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...

Validation Engineer What you will do In this vital role is within the Product Lifecycle Management organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. The team is responsible for new product introductions (NPI), product re-introductions (PRI) to Amgen Rhode Island’s Manufacturing Facilities (AR5 and AR30) and managing the lifecycle of ARI’s product portfolio. The schedule for this position is Monday – Friday Admin Day Shift. Responsibilities Support validation strategy and execute validation activities for manufacturing equipment, support equipment, and utilities, including validation planning, protocol development and execution,...