Quality & Regulatory Jobs in Pharma & Biotech

As Principal Compliance Engineer within our R&D team , you will play a key role in ensuring the timely and thorough execution of investigations to ensure clinical batches are best positioned for release. This position is critical to maintaining the highest standards of quality and compliance in our clinical manufacturing operations, directly supporting the development of life-changing medicines for patients worldwide. In this role, you will lead and contribute to cross-functional investigations, implement corrective and preventative actions (CAPAs) based on investigational conclusions, apply Lean methodologies to drive operational efficiency, and create and present quality event tracking to identify opportunities for...

Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy Available locations Barcelona, Spain Amsterdam, Netherlands Introduction to role Are you ready to set the global regulatory vision for pioneering cell and gene therapies and turn breakthrough science into real options for patients? This role leads high-impact programs across cancer, immune-mediated and rare diseases, guiding them from current stage through licensure with clear, competitive pathways to approval and labeling. You will shape strategy for complex, visible programs, bringing clarity, pace and rigor that accelerate access for patients. You will report to the Executive Director, Cell and Gene Therapy Regulatory Affairs...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for a Service and Repair Sr. Quality Engineer role to be located at Danvers, MA. Due to significant growth, Abiomed is working to develop and enhance Commercial and Service and Repair (S&R) capabilities globally, including Quality support to these functions. The incumbent will be responsible for supporting multiple workstreams in support of this development activity,...

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

The Sr. Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance. The Sr. Quality Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. Key Duties and Responsibilities Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions Participates in cross-functional teams as an experienced Quality technical resource Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed Assists Change Control owners with ensuring compliance to change procedure requirements Assesses and approves change controls...

Responsible for quality of assigned New Product Introduction (NPI) combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include infusion pumps, enteral and sub-cutaneous tubing, pump carrying accessories, and other drug administration system accessories. Products may be produced by AbbVie plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships. Develops the appropriate Regulatory, Quality and Product Development strategies for NPI products in concert with Regulatory Affairs, marketing, Product Development and other cross-functional stakeholders....

Purpose The Program Compliance Analyst (PCA) is responsible for monitoring and reconciliation to ensure data is accurate and compliant with 60+ individual country policies; and AbbVie’s OPPFs, procedures, and CFMs for all activity excluding top tier Congress activity. The PCA is also responsible for the successful close-out of activities, ensuring financial, transparency and compliance accuracy of all costs and activity associated with events planned within AbbVie’s Business Service Group or by Third Party Vendors, as required by country specific, federal and state government reporting and regulations. Ensure compliance with all US and country-specific laws and company policies for interacting with...

A Rare Opportunity to Shape the Future of Genomics Join a team of brilliant, passionate innovators determined to transform healthcare. At BillionToOne, we've built a category-defining, publicly traded company on Nasdaq where transparency fuels trust, collaboration drives breakthroughs, and every contribution moves the needle on our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we build products that are 10x better than anything that exists today. Our scientists, engineers, sales executives, and visionaries are united by an unwavering commitment to changing the standard of care in prenatal and cancer diagnostics. This is where...

About the role The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. As Manager Regulatory Lead you will be accountable for recommending and implementing regulatory strategy and coordinating life cycle activities across the portfolio of PDT products. How you will contribute Serves as the regulatory lead for one or more projects and coordinates the Global Regulatory Team (GRT) meetings composed of core regulatory support functions. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of plasma derived therapies, while ensuring...

Executive Director, Global Regulatory Affairs CMC Early Development Are you looking for a patient-focused company that will inspire you and support your career? Join us as Executive Director, Global Regulatory Affairs CMC Early Development (GRA CMC ED). Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Executive Director, GRA CMC Early Development, you will provide strategic and people leadership to deliver innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase 2 development. You will champion fit-for-phase CMC approaches that accelerate development while ensuring product quality, patient...

Position Overview - Basic Functions & Responsibility Essential function(s) includes, but is not limited to Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices including the device constituent part of Combination Products. This position will interact with cross functional teams working with all levels of employees. Activities will include developing, documenting, and maintenance of technical business solutions, reviewing and approving medical device/combination product documentation to support regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical...

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...

DePuy Synthes is recruiting for a Compliance DS Director, located in Massachusetts, US. The DPS Compliance Director is responsible for overseeing the entire DPS GS Compliance team, including governance of outsource SOX testing provider. The role will be based in DPS headquarters and will lead a team in GS hub footprints in Manila & Bogota . Key Responsibilities and Deliverables People & Org Change Management Coordinate cross ‑ functional workstreams and dependencies to deliver a fit for purpose L2 Compliance Organization Hire, Lead, coach and engage finance compliance team members assigned to DPS Support organizational design inputs and staffing decisions...

The Senior Director, Global Quality Systems holds a pivotal leadership position within the Quality organization. This individual is responsible for providing strategic vision and direction to advance the framework, strengthen organizational capabilities, and ensure the sustainability and effectiveness of the Quality Management System. The role is instrumental in promoting leading practices and supporting the organization's growth as well as adapting to industry changes. This leader provides strategic leadership and oversight across all aspects of Global Quality Systems. This includes guaranteeing the integrity and effectiveness of the framework, enhancing capabilities, and ensuring robust execution throughout GxP domains, various products, modalities, and...

If you have the passion and the drive to accelerate growth and make people’s lives better – then AstraZeneca is the place for you. In Cell Therapy Technical Operations (CTTO) we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking. AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery. AstraZeneca is accelerating fast. AstraZeneca is on track for...

Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About AstraZeneca At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Oncology Regulatory Science and Strategy Within Oncology Regulatory Science and Strategy (ORSS) we bring...

You will execute a wide range of regulatory submissions independently, including submissions of high complexity, contribute to global submission content plans, and lead review and planning processes for multiple products or projects. You will represent Regulatory Submission Management (RSM) on relevant product, project, and/or regulatory submissions teams, providing specialist guidance on regulatory submissions requirements and timing. You may also represent RSM on other cross-functional initiatives. You will plan and have oversight for assigned deliverables and may serve as the RSM lead for small to medium regulatory submissions. You will participate in identifying/developing process improvements, new standards, and updating systems in...

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...

The Senior Principal Regulatory Affairs Specialist will provide strategic regulatory leadership for multiple complex product development programs, with a particular focus on AI‑enabled technologies. This role is responsible for developing and executing global regulatory strategies, leading the planning, preparation, and submission of high‑quality regulatory filings, and ensuring alignment with evolving regulatory expectations for innovative digital and AI‑driven solutions. The individual will manage multiple workstreams, collaborate closely with cross‑functional partners, and proactively identify and mitigate regulatory risks to support timely approvals and successful market access. This position is intended for an experienced regulatory professional who can operate with a high degree...

Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. Our Pelvic Health Operating Unit advances care for patients living with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies, including sacral and tibial solutions. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor, these programmable therapies deliver personalized treatment supported by strong clinical evidence 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 Quality Technician III is a key support role within operations as part of the First Quality Response Team, responsible for rapid...

This position sits within the Regulatory Affairs Data and Product Release group in the Medtronic Clinical & Regulatory Solutions (MCRS) organization and leads the global Product Release team. The role is responsible for providing strategic direction and people leadership, coaching and developing managers and teams to deliver timely, accurate, and compliant product releases in support of global market access. A role within MCRS offers a unique opportunity to be part of a global, high-impact team, collaborating across functions, gaining visibility into enterprise-wide structures, and contributing to initiatives that drive meaningful impact across Medtronic. At Medtronic you can begin a life-long...

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,...

Duties/Responsibilities Lead the Campus IT Compliance and CSV team Promote a safe and compliant environment and mindset. Select, develop, coach, and manage the Devens Campus IT Compliance and CSV team. Set goals, objectives, and contributions of the Campus IT Compliance and CSV team. Drive continuous improvement of team productivity and KPIs. Ensure the team delivers critical projects on time. Act as a liaison between site stakeholders and enterprise/business application teams to ensure business continuity is maintained. Manage service providers and ensure alignment with contractual SLAs. Engage and support PBRG teams in support of the BMS culture. Act as the Computer...

The Manager Quality Systems - Change Control and Quality Risk Management (QRM) is responsible for supporting ownership and oversight of assigned quality systems per established local and global standards. This position supports the overall compliance and performance of the Change Control and QRM processes as they apply to the site level, including periodic assessments of process performance and continuous improvement opportunities. Duties/Responsibilities Support oversight of the Devens Cell Therapy site Change Control system, including facilitation of site Change Control Review Board. Drive Change Control governance maturity plans to improve site performance through data-based analysis and integration of management review through...

Key Responsibilities Own site‑level quality oversight for Manufacturing and Laboratory IT systems, including support for deviations, investigations, and CAPAs, ensuring sustained compliance and inspection readiness. Accountable for IT Change Management governance, providing risk‑based oversight and acting as the primary site authority for IT change control. Act as a Validation Lead for Manufacturing IT and OT systems, accountable for approval and lifecycle compliance of CSV and SDLC deliverables. Maintain ongoing compliance accountability for IT systems, procedures, and training supporting CAR‑T manufacturing and laboratory operations. Lead the Site IT System Periodic Monitoring program, ensuring effective execution, documentation, and remediation of compliance risks....

Key Responsibilities Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management. This will involve collecting all the relevant inputs from the RBM framework (CORM) as well as R&D Quality Clinical Quality Assurance on audits and inspections. As part of the upstream protocol authoring process, partner with Drug Development, in particular the CORM function, to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors and ensure...

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

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. We are recruiting for a Sr. Manager, Tech Quality Assurance to join our team on-site in Alameda, CA. In this role, you will be responsible for providing assurance that product...

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

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 general support of global regulatory activities. This role requires strong attention to detail, technical competence, and effective communication skills to collaborate across multiple functional areas. Proven successful track record of authoring/submission/approval implantable medical devices is preferred. What You’ll Work On Authoring and submitting US PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports), 510(k)s and EU change notifications. Review/approval of engineering study protocols/reports and validation study...

Regulatory Affairs Project Manager Our nutrition business develops science-based nutritional products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna®– to help get the nutrients they need to live their healthiest lives. At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to Career development with an international company where you...

The Program Operations Compliance Manager will play a critical role on the HCO team at Genentech. This role is responsible for operational elements and compliance guidance and reviews for external funding requests (e.g., grants, exhibits, sponsorships, corporate memberships), Advisory Boards, fair market value (FMV), and other areas of business need as assigned, including ensuring adherence to and oversight of applicable Genentech processes and guidelines. The role requires an individual with strong subject matter expertise on state and federal laws on interactions with healthcare professionals, a strong operational mindset to redesign workflows, eliminate bottlenecks, and actively implement cutting-edge technologies—including AI and...

The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant. Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned...

Manager Trainee — Quality (Travel and Relocation Required) Here is your opportunity to build a career in healthcare while fast-tracking your path to growth. As a Manager Trainee – Quality with BioLife Plasma Services, a subsidiary of global leader Takeda Pharmaceutical Company , you will learn and work in a structured management training program. You’ll build leadership skills that set you up for future growth, while receiving step-by-step training on how to rigorously monitor quality at our plasma centers. Upon completion of the program, you’ll advance into the role of Quality Manager Representative at one of our 175+ and counting...

Specialist Quality Assurance – AML 14 What you will do Let’s do this. Let’s change the world! In this vital role, you will serve as a Quality leader accountable for the investigation and resolution of minor deviations, safeguarding product quality and patient safety through sound judgment, strong ownership, cross‑functional collaboration, and effective risk management in a dynamic drug product manufacturing environment. Specific responsibilities include but are not limited to Serve as Quality investigation lead and decision-maker for complex deviations, maintaining accountability for designation, documentation quality, timeliness and closure. Actively participate in deviation meetings, managing multiple concurrent deviations and driving effective...

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 Senior Specialist, Supplier Quality to join our Innovative Medicine Quality Organization located in Raritan, NJ; Horsham, PA; Spring House, PA; Wilson, NC; or Gurabo, Puerto Rico. 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 Within the JJIM Supplier Quality...

Lead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global regulatory initiatives. Lead global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of product submissions. Develop global CMC regulatory strategies to enable life-cycle product/process development strategy while maintaining global licensure and right to operate of Gilead’s operations. Lead the execution of these global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development. Lead the integration and implementation of CMC Team Leaders...

This is a full time, on-site position with a schedule of 12 noon to 12 midnight on a rotating 2-2-3 schedule About This Role The QA Associate III has the working understanding, full knowledge and ability in their primary discipline. They are able to apply technical principles, concepts and understanding of systems and procedures in order to conduct quality and compliance related activities. They are proficient in their understanding of the Biogen Quality Systems. The QA Associate III has working knowledge of GxP regulations and adheres to all regulatory licenses and regulations as well as internal SOPs. The QA Associate...

2026 Fall Intern - PTQ Quality Processes Department Summary Global Quality and Compliance (PTQ) ensures we deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is a competitive advantage for Roche. You will report to the US Internship Program Manager in the PTQ Quality Process Function. The ideal candidate is a self-starter deeply curious and energized by learning. You should be comfortable with working through ambiguity and are able to prioritize and manage multiple demands and commitments. Your role will be to help Quality Processes fulfill...

The Senior Director, Device Quality provides global strategic leadership and accountability for Quality across medical devices, drug device combination products, companion diagnostics (CDx), and precision medicine–enabling platforms, including CLIA certified laboratory operations supporting clinical trials and commercial diagnostics. This role ensures patient safety, robust regulatory compliance, and sustained inspection readiness across the full lifecycle—from early development through commercialization and post market surveillance. The Senior Director partners closely with Precision Medicine, R&D, Clinical Development, Regulatory Affairs, Global Manufacturing, External Manufacturing, and Commercial teams to embed quality by design into innovative, personalized medicine solutions. This role is a key strategic position within...

This position works out of our Alameda, CA location within the ADC Division. Our mission is to empower people with diabetes to manage their health through innovative products that deliver precise data for better decision-making. We're transforming glucose monitoring with our cutting-edge sensing technology. As a Senior Specialist Import & Export, you will provide subject matter expertise to ensure site compliance with all relevant customs regulations and trade laws and regulations, including 19CFR, FDA, and other US regulatory agency requirements. This is an onsite opportunity in Alameda, CA. What You’ll Work On Responsible for compliance with applicable Corporate and Divisional...

At Medtronic, we A career at Medtronic is purposeful, mission-driven, and unlike any other. We are committed to alleviating pain, restoring health, and extending life for millions worldwide. Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities may include the following and other duties may be assigned...

This position will support the Surgical Sutures Manufacturing business within Medtronic’s Surgical Innovations group located in North Haven, CT. We are seeking a Senior Quality Engineer to join our team in North Haven, CT. A key requirement of this role is deep expertise in process validation across the full validation lifecycle, with the ability to support complex manufacturing processes in highly regulated environments. This role is integral to ensuring the highest standards of quality and compliance in our medical device manufacturing processes. As a key member of our Quality team, you will collaborate cross-functionally to enhance product reliability, optimize processes,...

Role is heavily focused to support the key site digital/software/automation transformation and related validation activities. The first two years will focus on validation of digital tools (MES systems, software, etc) and may require continued administrative support of this system. Responsible to perform adequate and comprehensive qualification and validation of equipment, processes, products, and facilities at the Redwood City site to support the site goals and targets. Responsible for assuring the design, installation, implementation, data integrity and validation of computer systems meet all applicable industry standards and regulatory requirements to support the site goals and targets. System or business owner and...

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

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

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 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease...

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...

We aspire to be the premier research-intensive biopharmaceutical company. At the forefront of research, we deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. The Director, Microbiological Quality and Sterility Assurance (MQSA) provides global leadership for microbiology-related topics across sterile, non-sterile, biologic, and vaccine manufacturing, as well as associated laboratories. This role sets and maintains quality standards and policies to ensure cGMP compliance, partners with sites across the network as a subject matter expert, and leads cross-site initiatives to drive consistency and continuous improvement. Join our team and use the power of leading-edge...

Essential functions include, but are not limited to Employee must show ability to perform routine assignments and develops competence by performing structured work assignments. Ability to use existing procedures to perform routine testing. Requires knowledge and exposure to fundamental laboratory instrumentation, theories, principles, and concepts. Receives instruction, guidance, and direction from others and also seeks advice/information from others when addressing serious business issues that may impact other functions. Builds and promotes the team's effectiveness through actions that demonstrate respect and appreciation for diverse perspectives. Demonstrates understanding of customer needs, requirements, and expectations. Seeks new ways to improve services to customers....

Regulatory Affair Director - Global Regulatory Leader (Rare Disease) What you will do The Global Regulatory Leader (GRL) is a product facing role that leads the Global Regulatory Team in the Regulatory Affairs organization. In this vital role you will lead one or more Global Regulatory Teams within Amgen’s Global Regulatory Affairs department and develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions. Additionally, you will provide regulatory expertise and guidance to product teams (eg, Product Team (PT),...

Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance What you will do In this vital role you will provide strategic direction for product and disease communications and activities by interpreting current FDA regulatory environment to ensure truthful and non-misleading communication to health care community, patients, and the public. This position is primarily responsible to formulate and communicate the regulatory promotional position for approved and/or pipeline products. Key Responsibilities Promotional review committee experience in evaluating proposed pieces and supporting evidence Evaluate promotional enforcement activities and assess the changing regulatory environment to determine impact on Amgen Update the Promotions group...

At Medtronic, we A career at Medtronic is purposeful, mission-driven, and unlike any other. We are committed to alleviating pain, restoring health, and extending life for millions worldwide. As a Supplier Quality Engineer based in Irvine, CA you will support the Neurovascular Operating Unit by ensuring externally sourced materials, components, and services consistently meet Medtronic quality and regulatory requirements. This role partners closely with Neurovascular R&D, Manufacturing, Operations Quality, and Sourcing to qualify and develop suppliers, support new product introductions and design changes, and resolve supplier-related nonconformances that could impact product performance or patient safety. You will lead investigations...

At Medtronic, we A career at Medtronic is purposeful, mission-driven, and unlike any other. We are committed to alleviating pain, restoring health, and extending life for millions worldwide. As a Supplier Quality Engineer based in Irvine, CA you will support the Neurovascular Operating Unit by ensuring externally sourced materials, components, and services consistently meet Medtronic quality and regulatory requirements. This role partners closely with Neurovascular R&D, Manufacturing, Operations Quality, and Sourcing to qualify and develop suppliers, support new product introductions and design changes, and resolve supplier-related nonconformances that could impact product performance or patient safety. You will lead investigations...

The Sr. Compliance Engineer will be involved in projects that require obtaining agency approvals for both new and existing products. This role requires experience in securing certifications from agencies such as the FCC, CE, EMC/RED, IC, and safety organizations. Familiarity with relevant standards and directives from UL, CSA, FCC, IEC, and EN is essential. Additionally, experience with environmental regulations such as RoHS, WEEE, REACH, and Proposition 65 is a valuable asset. The Compliance Engineer will create and execute a compliance test plan addressing EMC, EMI, safety, environmental, and other product compliance requirements. Key Responsibilities Read, interpret, and communicate changes in...

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of both marketed products and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. AbbVie is focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work to combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. We are currently seeking a Regulatory...

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...

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

Calico is seeking a Regulatory Director that will be responsible for, in collaboration with development partners as applicable, developing and implementing innovative regulatory strategies to support development programs, in compliance with health authority guidelines and regulations. The successful candidate should be able to collaborate effectively with cross-functional representatives, collaboration partners, external vendors, and stakeholders, while maintaining a positive team environment. Position Responsibilities Accountable to develop and execute the world-wide regulatory strategy for assigned programs (from IND-enabling to clinical proof-of-concept and beyond), which may include programs that are first-in-class, where no or limited FDA guidance exists, that have an external business...

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...

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. The Senior Manager, North America Regulatory Liaison will serve...

Located in Foster City, CA - this is a hybrid (3 days onsite) role. As a Sr Director, Regulatory Affairs at Gilead, you will... Responsible for leading and providing strategic input to all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Responsible for leading a team of Regulatory professionals supporting both early phase and marketed products. Responsible for ensuring responsibilities of Applicant and/or Marketing Authorization Holder defined in legislation or regulatory guidance's are met for assigned product(s) and territories. Responsible for submitting or ensuring submission of all...

This position works out of our Abbott Park, IL facility or an Abbott facility within the US. This is not a remote role. What You’ll Work On The function of the Quality Program, Manager is to provide leadership, oversight, and project management covering Abbott's Quality System. This includes division / business support and quality expertise and consulting activities. MAIN RESPONSIBILITIES 1. Lead global committees and teams 2. Provide direct business support 3. Participation in industry groups 4. Improve the effectiveness of the Abbott Quality System, including monitoring, trending and analysis of Abbott compliance performance 5. Act as a change agent...

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

As part of product development teams, executes product registration submissions, progress reports, supplements, and amendments. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liaison throughout product lifecycle. Participates in some of the following product plan development and implementation, regulatory strategy, risk management. Ensures timely approval of new medical devices and continued approval of on-market products and product changes. Serves as regulatory representative to marketing, research teams and regulatory agencies. Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Core Responsibilities Career development with an international company where you...

Quality Manager, CAPA The function of the Quality Manager, CAPA is to provide corporate-level leadership and guidance for Quality Systems matters related to nonconformance, investigation and C orrective And P reventive A ction (CAPA) processes and other related Abbott Quality System elements. This includes Business/Division support, quality and technical expertise and consulting activities globally. The incumbent must have a working knowledge of global regulations and industry standards related to nonconformance, investigation, and Corrective And Preventive Action (CAPA) processes. The incumbent should also have working knowledge and understand the relationship to other related Quality System elements, e.g., management responsibility, risk...

Regulatory Affairs Manager Introduction to role Are you ready to lead regulatory submissions that accelerate access to life-changing medicines? Do you thrive in a dynamic setting where your judgment shapes approval pathways and your work directly impacts patients in need? As a Regulatory Affairs Manager, you will own end-to-end planning, coordination and delivery of regulatory submissions across regions and modalities, translating scientific strategy into high-quality applications that secure timely approvals. You will identify risks and opportunities, advise cross-functional teams on procedural and documentation requirements, and guide products through development, authorization and lifecycle management. This role places you at the heart...

Experience in the medical device industry as a supplier quality engineer or manufacturing quality engineer preferred. Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost...

Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools for complex spine and cranial procedures. Platforms such as AiBLE™ connect these technologies to enhance surgical precision, streamline workflows, and support improved patient outcomes across...

That’s what makes us Roche! The Opportunity The PDQ Principal Quality Lead supports the Roche/Genentech Organization through the development and delivery of Quality strategies, audits and conclusions for entities (e.g. molecules in development, post approval products, affiliates, processes) based on a risk-based approach. Quality strategies are based on the Critical to Quality framework which encompass Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Personalised Healthcare (PHC) and Computer Systems (CS) requirements. The Quality Lead will generate Quality strategies, evidence and actionable data through the conduct of audits and other quality activities to assess the Quality status and be able to...

This role has responsibility and accountability for Ensuring that the facilities, equipment, systems, and processes used in the manufacture and testing of Pharmaceuticals have been appropriately validated and maintained in a validated state. Organizing and directing all validation activities including capital projects. Working with operations, requiring technical service support for process, product, facilities, and cleaning validation, change control, and continued verification which are essential for GMP and regulatory compliance and continuous improvement objectives. Ensuring robust and compliant validation and change control efforts. Provide leadership and direction to enable the site to meet its business goals by ensuring that laboratory business...

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. We need the...

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

Regulatory Affairs Senior Associate What you will do In this vital role you will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. Responsibilities Assist US Regulatory Lead (USRL) to support US regulatory activities (e.g. development and submission of Investigational New Drug [IND] applications, Biologic License Applications [BLAs] and New Drug Applications [NDAs]; advisory committee meeting preparations) Provide and maintain IND/BLA/NDA documentation support (e.g. annual reports, amendments) in collaboration with USRL Create and maintain product regulatory history documents in the regulatory...

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

Bristol Myers Squibb is seeking an Associate Director, Regulatory Excellence & Hematology/Oncology Operations to lead operational and business management activities within the Oncology/Hematology organization. This role serves as a strategic partner to leadership, driving execution of portfolio priorities, operational planning, compliance, and regulatory excellence initiatives across a team of approximately 45 professionals. The successful candidate will be recognized internally as a subject matter expert in regulatory operations and business management, exercising considerable latitude in shaping deliverables, leading initiatives of strategic importance, and developing solutions to highly complex, sometimes novel problems with broad impact across the department. The role requires anticipating...

Associate Director, Global Regulatory Strategy, Hematology/Oncology Position Responsibilities as a Global and US Regulatory Lead In conjunction with the Team leader; develop global regulatory strategy in development and through life cycle management taking into account all relevant guidance, commercial needs, and company objectives. Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions. Work with cross-functional groups to define and manage contributions to submissions. Writing regulatory documents (e.g. new INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents...

KNOWLEDGE AND SKILLS REQUIRED BS in Science, Engineering, or technical related field. Five 5 years of experience in Engineering Department related matters in the biopharmaceutical industry. Knowledge of EOHSS, cGMP’s, local/Federal regulatory requirements, and documentation procedures pertaining to a biopharmaceutical manufacturing plant. Timely and effective decision making, and timely conflicts resolution skills. Computer literate with the ability to understand and use basic computer software packages like Excel, Word, Power Point, Internet, etc. Ability to read and interpret layout drawings, mechanical, pneumatic and electrical blueprints, is preferred Fluently in English/Spanish (Oral and Written) Strong interpersonal relationship skills with subordinates, peers,...

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

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

The Associate Principal Quality Partner provides leadership and direction for Quality Assurance activities within Operations and serves as a senior quality resource for assigned functional areas. This role is accountable for driving effective implementation of quality systems, compliance oversight, and sound quality decision-making across the area of responsibility. The position focuses on product and process compliance, issue resolution, quality governance, and strategic quality improvement. This role partners closely with Operations, Manufacturing, Development, Regulatory, and other stakeholders to ensure compliance with AbbVie Quality Systems, cGMP requirements, and applicable regulatory expectations. The role is expected to maintain strong quality performance while driving...

As an individual contributor, this position performs 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. This new team member will support necessary regulatory activities required for product market entry. What You’ll Work On Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed. Reviews and evaluates communications to ensure communications convey all necessary...

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

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help get the nutrients they need to live their healthiest life. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself...

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

The Principal Regulatory Strategy Specialist is an individual contributor within Global Regulatory Affairs responsible for supporting and partnering with Regulatory teams across the organization as they shape and advance regulatory strategies aligned with Medtronic’s business goals and objectives. This role will partner closely with operating unit teams to provide additional expertise and guidance on complex, novel, and strategically important regulatory questions across the product lifecycle, including supporting effective due diligence for acquisitions. This role will help teams assess options, anticipate obstacles, and develop practical, risk-based pathways for innovative technologies across Medtronic, including but not limited to software-enabled products. The role...

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

Our team is involved in developing regulatory product strategies for the oncology therapeutic area, leading regulatory efforts in the development stage of drug products. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? The Regulatory Strategist provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within...

Job Title Manager Supplier Quality We currently have an opening for a Manager Supplier Quality for the Vascular division. This role can be located at our St. Paul, MN location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. WHAT YOU'LL DO MAIN PURPOSE OF ROLE Manages the development and administration of departmental activities of Supplier Assurance while maintaining compliance to, and driving continuous...

Job Title Quality Control Inspector III We are seeking a QC Inspector III for our Vascular division in Temecula, CA. This role is fully onsite role. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. What You’ll Work On The inspector provides an independent, unbiased evaluation of materials or the work of others. The results of the Inspector's evaluation is documented and communicated to organizational stakeholders with an interest in the evaluation's outcome - typically, this is supplier development and/ or manufacturing. The Inspector's approval certifies the work or material meets Abbott's quality system...

Johnson & Johnson is hiring for a Quality Compliance Specialist II – Shockwave Medica l to join our team located in Santa Clara, CA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at...

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

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

USE YOUR POWER FOR PURPOSE Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients. The Quality Compliance Engineer supports the Quality Organization by ensuring compliance with applicable regulatory requirements, company quality systems, and current Good Manufacturing Practices (cGMP). This role plays a key part in driving continuous improvement initiatives, leading quality‑related projects, and partnering cross‑functionally to strengthen compliance, efficiency, and inspection...

Use Your Power for Purpose Our dedicated manufacturing logistics and supply team ensures that customers and patients receive the essential medicines they require precisely when they need them. By embracing challenges, envisioning new possibilities, and taking decisive action, you will contribute to delivering medicines to the world with greater speed and efficiency. What You Will Achieve In this role, you will Plan and manage the efficient flow of products and services through the Pfizer supply chain cycle, ensuring compliance with in-country and international regulations. Ensure efficient operations by maintaining proper system interfaces between Pfizer and other required parties, monitoring the...

Job Title Sr. Engineer Supplier Quality We are seeking a high caliber Senior Engineer Supplier Quality. This position works out of our Temecula, CA location in the AVD Vascular division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. The Senior Engineer Supplier Quality 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 Assess potential new suppliers for...

This is not a remote opportunity Traveling up to 5 % What You’ll Work On Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Manage import/export process and develop effective internal controls to ensure site compliance with corporate and regulatory requirements. Provide leadership and direction to ensure site compliance with all relevant customs regulations and trade laws and other US regulatory agency requirements. Develop a staff of experts in the import/export compliance field that will serve the current and future demands of the supply chain operation. Act as subject matter expert and advisor regarding compliant importation and/or exportation...

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,...

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control Analytics - This position will be located in Raritan, NJ! The role will operate under the following shift Wednesday- Saturday 2pm-12am. Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Senior Software Design Quality Engineer role to be located at Danvers, MA. The Senior Software Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a key role in product risk management, cybersecurity, change controls, test reviews, and design controls. This engineer should excel in an environment...

The Senior Manager of Global Trade Compliance (GTC) – Technical Compliance will support Vertex commercial, clinical, research supply chains by ensuring the uninterrupted, compliant and efficient movement of product across Vertex’s global drug supply, clinical and research network. This individual has a global remit for building and maintaining the detailed technical compliance processes and governance needed to support the trade operations managers, and for assisting in solving detailed operational questions as needed. Areas of focus will include customs valuation and export controls but will also be responsible for product classification (HTS, ECCN & PGA), country of origin (non-preferential & preferential),...

Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy Introduction to role Are you ready to set the global regulatory vision for pioneering cell and gene therapies and turn breakthrough science into real options for patients? This role leads high-impact programs across cancer, immune-mediated and rare diseases, guiding them from current stage through licensure with clear, competitive pathways to approval and labeling. You will shape strategy for complex, visible programs, bringing clarity, pace and rigor that accelerate access for patients. You will report to the Executive Director, Cell and Gene Therapy Regulatory Affairs and act as a franchise global...

Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines? At AstraZeneca , we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet...

Job Title Director, Regulatory Affairs Strategy - Cell and Gene Therapy Introduction to role Are you ready to steer global regulatory strategy for cell and gene therapies that redefine standards of care for patients? In this Director role, you will shape the regulatory path for programs that span oncology, immune-mediated and rare diseases—translating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets. You will join a high-performing, cross-functional environment where regulatory insight is central to program decision-making. Partnering with senior leaders and global teams, you will lead strategy across key milestones—from...

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease...

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease...

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

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This position is onsite 4 days per week in North Haven, Connecticut. Our Medtronic Surgical team is working to bring the benefits of minimally invasive surgery (MIS) to more people and places through a portfolio of robotic and digital solutions. Together,...

About the Role Takeda is seeking a legal leader to join our Global Transactions & Contracting Legal (GTC Legal) team. As Head Counsel, GTC Legal – Global Supply & Quality (GSQ) and a valuable member of the GTC Legal leadership team, you will lead a team of attorneys and legal professionals supporting transactions and contracts for Takeda’s GSQ organization. This is a highly visible leadership role where you will lead novel, complex, high‑impact, high‑risk transactions while empowering Procurement and the business on routine contracting matters. You and your team will partner closely with Procurement and business stakeholders to drive business...

About this role Join Takeda as a Head of Global Regulatory Affairs – Oncology where you will provide global regulatory oversight for the assigned therapeutic area, focused on non-clinical and clinical aspects of drug development and associated regulations. You will provide asset-level responsibility for both US and EU HA interactions and procedures (including direct reporting lines). As part of the Global Regulatory Affairs team, you will report to the Head of Global Regulatory Affairs and provide core input to Global Program Team(s) throughout development programs. How you will contribute Provide enterprise-level leadership and vision for global regulatory affairs across the...

An engineering/analyst professional who applies engineering and/or scientific knowledge, mathematics, and ingenuity to complete basic assignments related to a specific technical field or discipline. Responsible for compliance with applicable regulations and standards for Quality; Environment, Health, and Safety (EH&S) Global Policies; AbbVie Engineering Standards; and other governance areas as applicable. Identifies areas of risk with respect to compliance. Assists in development and revision of procedures and standards Facilitates the definition of a project scope with stakeholders. Converts goals to tasks and steps. Within structure, plans own work, manages several, often concurrent, tasks to accomplish assigned tasks to meet or exceed...

We are seeking a Senior Supplier Quality Engineer to help strengthen our supplier quality systems and ensure the highest standards of compliance, reliability, and performance across our global supply base. In this role, you will partner with suppliers and cross-functional teams to proactively identify risks, resolve quality issues, and drive continuous improvement. Responsibilities Monitor the performance of suppliers on a continuous basis and escalates any potential issues to supplier quality management. Supports the completion of supplier risk assessments and updates supplier quality database accordingly. Ensures supplier quality database is updated timely with any new information/addition, and ensures its accuracy, i.e....

Global Quality Compliance, Senior Manager What you will do Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities Coordinates and leads or participates in Global Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, Critical Service Providers, Suppliers, Partners, and Wholesalers to assess compliance with all applicable regulations and to identify top compliance risks. Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to...

In this role, you'll partner across Engineering, Manufacturing, Operations, and Quality teams to develop and maintain robust quality systems, drive continuous improvement initiatives, and ensure products and processes consistently meet regulatory, customer, and business requirements. You'll leverage technical expertise , data-driven decision-making, and cross-functional collaboration to solve complex quality challenges and help deliver safe, effective products to market. This position is based onsite in Danvers, MA. We believe in the value of in-person collaboration and operate with a minimum 5-day-per-week onsite schedule to support innovation, learning, and cross-functional partnership. Key Responsibilities Lead the development, implementation, and maintenance of quality...

About the role This position supports the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. How you will contribute Lead the execution of CD/PQ/CV/PV/RV activities. Act as project manager for validation deliverables ensuring new systems are implemented within predetermined timelines and financial forecasts. Supervise and manage contractors or consultants as needed. Participate in change control review board. Track and trend...

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

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities Provide direct shop floor quality support to ensure manufacturing activities are performed...

As an individual contributor, the International Regulatory Affairs Specialist I performs 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. This new team member will support necessary regulatory activities required for product market entry. This individual will work on-site at our Plymouth, MN location. What You’ll Work On Assists in the preparation of regulatory applications to achieve departmental and organizational objectives, specifically for Asian geographies. Provide regulatory input to product lifecycle planning. Monitor regulatory outcomes of initial product concepts and provide input to regulatory management....

The Senior Supplier Quality Assurance (SQA) is responsible for developing and executing supplier quality strategy, ensuring compliance with global regulatory requirements, and improving supplier performance across a diverse supply base. This role leads supplier auditing, qualification, risk management, and issue resolution, partnering closely with Procurement, R&D, Manufacturing, Regulatory Affairs, and other departments within the quality organization. This role will also learn to balance supplier requirements between medical device and consumer businesses. The individual will serve as the primary escalation point for critical supplier issues and supports major regulatory inspections across the business. This position will be located out of our...

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

The Robotics and Digital solutions (RAD) group, part of the Johnson & Johnson family of companies, is recruiting for a Sr. Compliance Engineer (Safety). What We Do At Johnson & Johnson MedTech, we are building the future of robotic surgery and healthcare through innovation and technical excellence. Our goal is to develop advanced robotic platforms that are precise, reliable, and accessible. Our team focuses on creating solutions that empower surgeons and improve patient outcomes worldwide. for Pay Transparency

Purpose Primarily responsible for ensuring adherence to GLP regulations and developing an organizational model for the Quality Assurance Unit. Manage a team of audit professionals responsible for quality oversight of all GLP-regulated studies. Poor decisions could present significant risks to patients in clinical trial programs, jeopardize the outcome of pre-clinical or clinical trials with resulting adverse business impact, or result in rejection of regulatory filings owing to compliance issues. These outcomes would adversely affect sales, margin, and stockholder value. Responsibilities Manage auditing for compliance of all GLP-regulated in-house studies and regulatory dossiers prior to filing. Collaborate with GXP...

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

POSITION OVERVIEW The Executive Director, Head of Precision Medicine Regulatory is responsible for defining and leading enterprise-wide regulatory strategy for precision medicine, including companion diagnostics (CDx), in vitro diagnostics (IVD), and biomarker-driven development across all Gilead therapeutic areas. This role ensures seamless integration of diagnostic and therapeutic development strategies from early discovery through global registration and commercialization, while maintaining direct accountability for regulatory strategy and execution of CDx/IVD programs. The position operates at the intersection of enterprise leadership, technical regulatory expertise, and operational execution to enable scalable, compliant, and innovative precision medicine across the Gilead and Kite portfolios. You will...

Quality Control Specialist, Microbiology What you will do In this vital role, you will provide technical and operational leadership for the QC Microbiology and Environmental Monitoring laboratories, leading microbial identification activities, environmental monitoring investigations, and laboratory operations in a highly dynamic, team-oriented environment. In this role, you will be responsible for Lead microbial identification activities, organism assessments, and support routine and non-routine microbiological testing. Provide leadership for microbiology laboratory operations, coordinate daily priorities, supervise laboratory staff, and support weekend laboratory operations. Own and lead complex microbiological investigations, deviations, environmental monitoring excursions, and contamination events, including root cause analysis, risk...

Senior Associate Quality Assurance What you will do Let’s do this! Let’s change the world! The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements. Duties include but are not limited to Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments...

In this vital role, you will be part of the Supply Chain team and report to the Senior Manager. You will participate in multiple cross-functional initiatives for Amgen Ohio (AOH) leading to the warehouse quality process applying enterprise-wide programs. In addition, you will organize, drive, and/or support the identification and implementation of related Warehouse systems and processes. This role is also responsible for identifying, establishing, modeling, and monitoring key performance measures that will ensure the achievement of Best Practices across Amgen sites. The Manager, Warehouse Quality Systems, will serve as a key representative on various cross-functional task forces and teams...

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

Associate Director, External Quality Location Boston, MA Hybrid 3 days/week Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next generation radio conjugates (RCs) as precision medicines. Fusion has multiple pipeline programs entering early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support these programs, Fusion has a fully operational radio conjugate manufacturing facility. It is brand new and GMP compliant to meet the demand for our growing pipeline of RCs. AD, External Quality –...

In AstraZeneca's Cell Therapy division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying , and even curing some of the world's most complex diseases. We have the potential to grow our pipeline and positively impact the lives of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. This role is part of the Cell Therapy Supply Chain team tasked with supporting critical...

The Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global regulatory strategy for development programs or marketed products. This role will serve as a global regulatory lead, or in some cases a regional regulatory lead, for development and/or commercial product(s) within the Vertex portfolio and contribute to the global regulatory strategy for the assigned program(s). This role requires advanced understanding of regulatory affairs frameworks in the US, Europe, or other international markets, drug development, and related concepts, and the ability to translate this knowledge into effective regulatory planning and strategy development. Key Duties and...

The Sr. Quality Engineer, New Product Development, will be responsible for providing quality engineering support and leadership for New Product Development. Responsibilities Launch and stabilize new product launches through concept, design, development, and steady-state processes. Drives the development of product requirements, verification strategies, and validation strategies. Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction. Proactively engage partners to drive consensus and resolve issues in a timely fashion. Provide statistical support...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. The Medtronic Global Operations and Supply Chain (GOSC) organization is seeking a Quality Engineer II to join our growing Quality Operations team in Irvine, California. In this role, you will support key programs within our Quality Management System and help drive day-to-day quality and...

Job Title Quality Engineer We are seeking a Quality Engineer for our Westford, MA location for our Vascular division. This role is fully onsite. The Quality Engineer provides Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provides Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. This role will include primarily working on and leading project teams to drive process/Quality improvements. What You’ll Work On Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the...

This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Supplier Quality Enginee r II 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 Assess potential new suppliers for technical, quality and...

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

About the role The Senior Manager, Software Device Quality is a seasoned quality and technical leader responsible for supporting software medical devices and combination products across the full product lifecycle - from design and development through manufacturing, distribution, and post-market support. This role ensures compliance with all applicable quality and regulatory requirements and provides leadership across key quality processes. How you will contribute Partner with product development teams to lead quality activities across design controls, including risk management, design inputs/outputs, verification/validation, and design transfer Provide quality oversight and approval for change control activities, including design updates, enhancements, bug fixes, and...

Título del Puesto Regulatory Affairs Analyst Ubicación Ciudad de México Modelo de trabajo híbrido Acerca del Puesto Como Regulatory Affairs Analyst , tú apoyarás la ejecución de la estrategia regulatoria para los productos asignados, gestionando registros, renovaciones, modificaciones posteriores a la aprobación y materiales promocionales, con el fin de obtener las autorizaciones sanitarias requeridas para las distintas unidades de negocio. Además, garantizarás la preparación y presentación de expedientes regulatorios completos ante las autoridades sanitarias locales, asegurando procesos de revisión efectivos que permitan obtener aprobaciones oportunas y contribuir al cumplimiento de los objetivos del negocio. ¿Listo para comenzar? ¿Listo para superar...

Purpose Primarily responsible for leading the management of GCP quality activities in support of studies and projects across one or more clinical programs to drive proactive quality management, and ensure compliance with corporate policies and functional procedures and applicable global regulations. As the primary GCP quality interface cross-functionally in R&D for the product, this individual will influence and provide oversight of activities that include execution of the Comprehensive Quality Strategy game plan, informal surveillance, assessments as appropriate, design and execution of a “fit for purpose” audit program with the goal of submission-ready quality data, first pass approvals by health authorities...

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

Senior Compliance Specialist This position works out of our Altavista, VA location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Altavista, Va. , is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you...

This position works out of our corporate Abbott Park, Illinois location, or other applicable Abbott 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...

Senior Associate Quality Control - Microbiology What you will do Let’s do this. Let’s change the world! In this vital role, you will support the QC Microbiology and Environmental Monitoring team by performing activities including microbial investigations/assessments, microbiological and analytical testing, sample and data management, equipment and instrumentation operation and maintenance, sample and equipment troubleshooting, and the review and authorization of documents and samples while performing in a highly dynamic, team-oriented environment. Responsibilities include Perform microbial assessments and other GMP documentation as required (reports, assessments, SOP revisions). Support microbial and other QC laboratory investigations. Perform Microbiological testing to support GMP...

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease...

Summary This position is critical to maintaining quality oversight and ensuring GMP compliance in day-to-day manufacturing operations. The Senior Field QA Specialist is responsible for reviewing Manufacturing Batch Records (MBRs), performing real time on-the-floor exceptions reviews and logbooks, conducting GMP area walkthroughs, and supporting timely return-to-service (RTS) walkthroughs to confirm that manufacturing areas and equipment are properly cleaned, calibrated, and ready for production use. The role also working closely with Manufacturing Operations to investigate and resolve manufacturing issues as they arise. Additionally, this position contributes to authoring and revising quality SOPs, supporting the review and closure of no-impact manufacturing deviations,...

We are seeking a qualified individual to join our R&D Quality Assurance Analytics & Tech Systems (AnTS) team. This role will be responsible for supporting both AI governance activities and quality systems management. The successful candidate will work closely with our business stakeholders to build our GxP AI Framework and lead demand discussions for our Veeva quality systems modules. They will need to be able to communicate information in a clear, concise, and timely manner and implement the use of negotiation, business analysis, project management, data analytics, and other applicable skills to resolve complex issues. Key Responsibilities Support QA AI...

We are searching for the best talent for a Regulatory Law Paralegal to primarily support the Innovative Medicine Regulatory Legal Team (IMRLT) in the Global Legal Organization (GLO). This position is based in either New Brunswick, NJ; Titusville, NJ, or Horsham, PA. The Regulatory Law Paralegal contributes to the achievement of key Johnson & Johnson GLO priorities by providing proactive and professional support to the IMRLT and its business partners. You will be responsible for Working closely with regulatory lawyers and business partners to assist in the support and review of commercial and compliance programs and materials, which could include...

Associate Director Strategic Planning & Operations - Quality Strategy Organization What you will do Let’s do this! Let’s change the world! As a member of the Global Quality Strategy organization team, this individual will manage projects and initiatives in Global Quality portfolio in support of the end-to-end GxP operating model. The role involves cross-functional partnership and influence to ensure successful execution and lifecycle management of continuous improvement and strategic projects. Key Responsibilities Partner with cross functional senior management to ensure successful execution, tracking and value realization of critical initiatives and projects aligned with Global Quality GxP operating model. Stand up,...

Quality Assurance 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 Assurance 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...

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 Sr Manager Quality Assurance – GMP Operations at Gilead, you will provide Quality leadership and direct quality oversight of Manufacturing...

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. The Associate Director, Quality Assurance – GMP Operations provides senior Quality leadership and direct quality oversight of Manufacturing and Quality Control (QC)...

Our Research Laboratories Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle, including post approval marketing, to ensure high-quality, safe, and effective products, contributing to the company mission of improving and saving lives around the world. Our Research Laboratories QA Clinical Quality (CQ) provide independent assurance that our company ensures the safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and strategies for ensuring data integrity in our clinical trials. Primary Responsibilities Leads their own specific tasks and responsibilities within...

An engineering professional that works with project owners, automation engineers, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified automated systems equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The primary objective is to design and execute robust evaluation, testing, and documentation strategies that support risk management, commissioning, and validation in alignment with product, regulatory, and quality requirements. The role also contributes to optimizing automated systems, process controls, and related technical workflows...

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

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

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

About This Role As a Senior Associate II, Technical Quality, you will play a critical role in ensuring quality and compliance across manufacturing, laboratory, engineering, and quality operations. You will lead and support investigations, change controls, quality oversight activities, and continuous improvement initiatives that strengthen operational performance and regulatory compliance. This position serves as a key technical quality subject matter expert, partnering cross-functionally to solve complex problems, assess risk, and implement effective quality solutions. You will provide quality assurance oversight for quality control activities, technology transfers, material management, and regulatory inspection readiness. This role helps drive a culture of quality,...

USE YOUR POWER FOR PURPOSE Candidate will be responsible to provide leadership for will be responsible for managing a team of Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity within the Rochester Quality organization. Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and performs second level reviews as required. Provides oversight of department, ensuring proper use of assets, budget, and...

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. Job Summary The Associate Director, Patient Safety-Virology provides strategic pharmacovigilance leadership for one or more products, compounds, or indications across the development...

Quality Engineering Manager This position works out of our Altavista, VA location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Altavista, Va. , is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you...

Quality Engineer II This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Quality Engineer II, you’ll have the chance to provide process/quality engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Also provide process/quality engineering support to product development teams, helping to ensure development of highest quality new products. What...

The GMP Quality Operations Manager is recognized internally as an expert in the principles and application of quality assurance, compliance, and AI-enabled quality operations. The Quality Manager will provide QA support of manufacturing operations for the external manufacture of Cell & Genetic Therapeutic programs. This role will drive, review, and support activities related to product disposition, including review of batch data, batch records, deviations, in-process data, EM data, QC release testing, and other quality systems documentation, while advancing intelligent digitized solutions for backlog triage, metrics generation, records reconciliation, and archiving to improve operational efficiency, compliance, and data integrity. Key Duties...

A Day in the Life In this meaningful role as a Quality Engineer II supporting Cardiac Ablation Solutions (CAS), you will play a vital part in ensuring product quality, safety, and reliability through post‑market activities. You will perform complaint investigations, partner closely with engineering teams to identify and escalate risk file signals, and support data‑driven decisions that protect patients and clinicians. This role supports the development and continuous improvement of procedures, processes, tools, and techniques used for product analysis and returned product evaluation. You will devise and implement inspection and testing methods for returned product, support test method validation efforts,...

Information Systems Sr. Manager – Technology Regulatory Compliance Lead Live What you will do In this vital role, you will lead the delivery of high-quality, robust, and reliable digital technologies and services within the Technology Organization, ensuring seamless support for business, project, and daily operations. You will be accountable for the computer systems compliance framework of the technology function, ensuring adherence to global regulatory requirements and Amgen procedures. You will lead the strategy for computer system validation (CSV), regulatory compliance, and inspection readiness for the technology team, proactively driving a culture of quality and continuous compliance. Serving as the...

Quality Compliance Associate Director – Aseptic Processing What you will do In this vital role, you will serve as a Quality Compliance microbiology subject matter expert supporting contamination control, QC microbiology, manufacturing microbiology, inspection readiness, and technical consistency across Amgen Operations. This role partners with Quality, Manufacturing, Process Development, Regulatory Affairs-CMC, Cellular Sciences, site laboratories, and global technical networks to ensure science-based, compliant, and practical decisions. This is a full-time remote position Specific responsibilities include but are not limited to Serve as a aseptic processing and contamination control subject matter expert for Quality Compliance, Manufacturing, and site teams. Support...

Quality Compliance Associate Director - Microbiology What you will do In this vital role, you will serve as a Quality Compliance microbiology subject matter expert supporting contamination control, QC microbiology, manufacturing microbiology, inspection readiness, and technical consistency across Amgen Operations. This role partners with Quality, Manufacturing, Process Development, Regulatory Affairs-CMC, Cellular Sciences, site laboratories, and global technical networks to ensure science-based, compliant, and practical microbiology decisions. This is a full-time remote position Specific responsibilities include but are not limited to Serve as a microbiology and contamination control subject matter expert for Quality Compliance, QC laboratories, manufacturing, and site teams....

The Senior Manager, Regulatory Affairs US Advertising and Promotion – US Specialty combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications...

The Senior Manager, Regulatory Affairs US Advertising and Promotion – US Specialty combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications...

The Senior Manager, Regulatory Affairs US Advertising and Promotion – US Specialty combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications...

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

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...

In this exciting role as a Senior Supplier Quality Engineer in CardioVascular Surgery (CVS), you will work on supplier quality deliverables and lead supplier control activities for new product development programs for the Aortic portfolio. You will be responsible for supporting supplier quality excellence to enable the successful development and launch of programs supporting the Aortic portfolio of the business. This role collaborates with cross-functional teams and suppliers to ensure effective component development, qualification, and release processes that align with program timelines and regulatory requirements. The ideal candidate will have strong experience managing supplier changes during NPD programs, effectively communicating...

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...

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

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

Director, Product Quality Complaints Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that...

The Director, Global Regulatory Affairs Process Excellence & Transformation leads complex, cross-functional operational excellence initiatives across Global Regulatory Affairs (GRA). The role is responsible for identifying, designing, and implementing process improvements that enhance efficiency, consistency, and quality across GRA processes. As a key member of the GRA Process Optimization Network (GPON), this role consults with cross-team representatives to diagnose operational challenges and deliver scalable, sustainable solutions. The Director applies deep subject-matter expertise and hands-on operational excellence experience to shape objectives and drive transformation aligned with GRA and corporate goals. This is a Boston based, hybrid position requiring 3 days/week onsite....

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to Career development with an international company where you can grow the career you dream of . Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year An excellent retirement savings...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements. What You’ll Work On Contributes to the development, maintenance and improvement of division supplier development quality program...

This is not a remote opportunity Traveling up to 5% Our team is looking for a Customs and Trade Compliance Analyst to be based out of our office in Irving, TX. Responsible for providing technical and analytical support for customs and trade compliance matters at the site/division level, ensuring compliance with all relevant customs regulations and trade laws including, 19CFR, 15CFR, FDA, USDA, other PGAs and data metrics. FTZ Operations and Compliance Administer and maintain FTZ operations in compliance with CBP regulations (19 CFR Part 146) and FTZ Board guidelines. Manage FTZ admissions, withdrawals, transfers, and inventory movements within the...

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...

Senior Specialist, Quality Risk & Governance What you will do Let’s do this. Let’s change the world! At Amgen, quality is more than compliance — it is a strategic capability that enables innovation, operational resilience, and trust across the product lifecycle. We are seeking a Senior Specialist, Quality Risk & Governance to help strengthen and evolve our enterprise GxP Quality Management System through proactive risk management and effective governance practices. This role combines a strong emphasis on Quality Risk Management (60%) with strategic and operational support for GxP Governance (40%) , helping ensure enterprise-wide visibility, escalation, decision-making, and continuous improvement...