Quality & Regulatory Jobs in Pharma & Biotech

The Compliance Analytics & Monitoring Manager leads proactive compliance monitoring and data-driven insights initiatives for International Marketing Commercial Operations (IMCO) and International Market Access and Pricing (IMAP). In addition to driving effective monitoring, this role champions the use of advanced data analytics to detect trends, identify root causes, and share actionable insights across international business units. The role reports to the Associate Finance Director, International Marketing – Specialty Products. Major Responsibilities Lead the development and execution of comprehensive annual compliance monitoring and analytics plan, aligning with business goals and OEC requirements. Integrate advanced data analytics to proactively identify compliance risks,...

Supplier Quality Engineer II – Pre-Market, Cranial & Spinal Technologies 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 advances surgical care for spine and cranial conditions through an integrated ecosystem of implants, navigation, robotics, imaging, and planning tools. Platforms like AiBLE enhance precision, efficiency, and outcomes for complex procedures worldwide. Check us out...

Supplier Quality Engineer II - Software Careers That Change Lives In this exciting role as a Supplier Quality Engineer II - Software you will have responsibility for review and approval of software elements and software of unknown provenance (SOUP) items developed outside of Medtronic; partnering with sourcing teams for the selection, evaluation, approval and ongoing performance monitoring of software suppliers; and working with software development and New Product Development teams to qualify and release software product to support CRM and CDS products and devices. CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well...

Today, we’re partnering across the industry to confront systemic healthcare challenges – this requires bold leadership. If you want a challenging, energizing, rewarding career that changes lives, join us. Help us bring the next generation of life-changing medical technology to patients worldwide. At Medtronic, we must work with a sense of purpose and ownership, knowing there is a human life on the other side of every decision. 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...

As the Regulatory Affairs Manager, you will be responsible for establishing strategy for worldwide product approval submission activities, directly responsible for execution of submission activities focused on US/EU and for ensuring regulatory compliance for Acute Care and Monitoring products. The Regulatory Affairs manager is expected to accomplish results through hands on and delegation of responsibility to individual contributors. This role will require collaboration with business partners to develop regulatory strategies to support the business goals and translate the strategies into work plans for the Regulatory Affairs teams to implement the newly created ACM OU is committed to excellence in innovation...

Careers That Change Lives In general, the following responsibilities apply for the Senior Quality Engineer role. This includes, but is not limited to the following Performs trending for Cardiac Ablation Solutions products Escalates trending signals as appropriate Provides cross functional partners with data requests as needed Defines , tests, and validates new data sources and reports Travel requirement 0% Qualifications – Must Have - Minimum Requirements TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME Bachelor’s degree in engineering , m ath, s tatistics, or a technical discipline Minimum of 4...

This Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment. In this role, you will combine knowledge of scientific, regulatory, and business issues to enable products...

Position Overview Abbott Nutrition, Casa Grande, Arizona, is seeking a highly motivated Quality Assurance professional to serve as the primary quality representative supporting cross‑functional project teams. This role is responsible for ensuring products, processes, equipment, and systems meet Abbott Nutrition Quality System requirements and applicable regulatory standards across the full product lifecycle. The ideal candidate brings strong quality engineering expertise, a working knowledge of GMP and food/nutrition regulations, and the ability to influence teams, resolve issues, and drive continuous improvement. This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops...

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 can be located in Titusville, NJ; Raritan, NJ; or Spring House, PA. The Senior Manager, North...

Regulatory Affairs Director Oncology R&D Gaithersburg, MD Hybrid Work- on average 3 days a week from office The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialisation, and life cycle management of the assigned cell and gene therapy (CGT) product(s). You'll s erve as the global regulatory lead ( GRL ) on early - stage projects or be responsible for specific indications or jurisdictions of larger programs . You'll have the opportunity to contribute significantly to product and clinical strategy and support cross-functional alignment for governance and health authority interactions . Th e RAD also...

The Senior Quality Associate I is responsible for supporting quality system administration, training compliance, website maintenance, training content development, and audit readiness activities. This role serves as a key administrator for ComplianceWire electronic learning management system (LMS) and associated training systems, ensuring accurate assignment, tracking, reporting, and maintenance of training requirements across assigned sites. The position also supports the development and management of training materials, user groups, service provider accounts, and annual access audit activities. Key Responsibilities ComplianceWire Administration Serve as the site system administrator for ComplianceWire for the cGMP site and other assigned sites, as needed. Support EHS and...

Job Title Sr. Quality Engineer We currently have an opening for an Senior Quality Engineer for the Vascular division. This role is located at our Temecula, CA location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. MAIN RESPONSIBILITIES Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. Reduces and controls manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused...

Job Title Specialist Quality Assurance We currently have an opening for an Specialist Quality Assurance for the Vascular division. This role is located at our St. Paul, MN location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. MAIN RESPONSIBILITIES Supports in the selection, approval and maintenance of Division's approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities. Ensures that the Division Approved Supplier List is maintained and accurate. Assesses potential new suppliers and service providers for quality...

The compliance specialist will support regulatory compliance for marketed products by means of compliant and timely handling of quality compliance and regulatory related activities at Swiftwater. The incumbent manages internal audits, regulatory compliance exercises, and regulatory activities linked to the site. About Sanofi We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Main Responsibilities Contributing to the development and...

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 Collect Environmental Monitoring (Viable Air, Viable Surface, Non-Viable Air Samples) and Critical...

Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as Consumer Eyecare Products, Ocular Implants, Pre-filled Syringes, Autoinjectors, Aesthetic Devices, etc. Primary driver for the quality and compliance aspects of product transfer and on-market change management. Serves as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of AbbVie. Lead/support process validation...

The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and...

The Senior Quality Engineer, Risk Management has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending,...

The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and...

The Manager, Quality Assurance provides leadership and direction to the Quality Assurance Function. This Manager role is responsible for the effective implementation of the functions within operations that could include Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation of product and processes, Quality Engineering, Training, Regulatory Compliance, Quality Planning and strategic initiatives. The Manager of Quality Assurance would be expected to work within a budget and leads a team who are responsible for compliance and quality systems implementation. Expectations that the Manager will maintain high quality levels on all aspects of their job while achieving high...

The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and...

The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and...

The Senior Quality Engineer, Risk Management has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending,...

The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and...

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. The Senior Principal Scientist, Regulatory Affairs Liaison is responsible for the development and implementation of worldwide regulatory strategy for programs in the General Medicine therapeutic area with specific focus...

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

The Senior Specialist - IT Quality provides quality oversight and compliance leadership for regulated data center facilities, utilities, and equipment supporting healthcare and GxP - relevant IT operations. This role ensures that data center physical infrastructure and supporting systems are operated, maintained, and controlled in compliance with applicable regulatory requirements, internal quality standards, and industry best practices. The position partners closely with Facilities Engineering, Data Center Operations, IT Infrastructure, Quality, and Safety teams to ensure inspection readiness, lifecycle control, and sustained reliability of critical data center environments. Primary Job Function Individual contributor with comprehensive knowledge in specific areas and performs...

Sr. Manager, Global and U.S. Healthcare Compliance Policy What you will do In this vital role you , as a key member of the Global Policy, Training and Systems team within Worldwide Compliance & Business Ethics (WC&BE), this individual leads the strategy, governance, development, and lifecycle management of Amgen’s Global Corporate Compliance Policies, U.S. BlueBook, U.S. Healthcare Compliance SOPs, and related compliance resource documents. This role ensures alignment and consistency across global and U.S. compliance policies and serves as the primary bridge between policy content and enterprise compliance training, including the Global Code of Conduct and U.S. Healthcare Compliance...

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 Process Quality Technician to be based in San Angelo, TX . Under the guidance of the Process Quality Leader, the Process Quality Technician (PQT) provides technical support to identify causes for non-conformances and process failures. Furthermore, the PQT implements corrections to maintain process performance and compliance with Ethicon's QSR, GMP, and ISO requirements. Key...

We are searching for the best talent for a Senior Manager, Government Contracting & Pricing Compliance Officer (GCCO) to be located in Titusville, NJ or Raritan, NJ. 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 Purpose This position will serve as the GCCO for assigned Johnson & Johnson Companies. The GCC Officer leads and drives the GCC Program to ensure business practices and activities are compliant with J&J guidelines, regulations...

We are searching for the best talent for Manager, Quality – Polyphonic to join our Quality organization located in Santa Clara, California or Cincinnati, OH. Remote work options may be considered on a case-by-case basis and if approved by the Company. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The Manager, Quality – Polyphonic is responsible for supporting product quality and reliability ensuring the implementation of ground breaking technology for...

Director, US Regulatory Lead, GRS The Director, U.S. Regulatory Lead (USRL) will oversee regulatory strategy and execution for Immunology and Cardiovascular therapeutic area, with a primary focus on management of pulmonology asset and associated Health Authority (HA) interactions along including upcoming NDA submission. The incumbent may also serve as Global Regulatory Lead (GRL)/USRL for an early or late development asset, responsible for leading IND preparation and submission, and for developing regulatory strategy across lifecycle phases. Expected Areas of Competence Develop and lead U.S. regulatory strategy and execution for a Development Team (s), including first NDA submission and ensuring...

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shift Day shift, Panama schedule (12-hour shift patterns with a 2-2-3 work cycle including weekends and holidays) 6 am to 6 pm Duties/Responsibilities Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations. Able to interpret problems and effectively prepare surrounding communication...

The Associate Director, Global Trade Compliance (GTC) Business Process Owner (BPO) is responsible to develop and maintain processes and GTC systems that enable compliant, consistent, accurate and efficient filing of customs declarations for all Vertex exports and imports; as well as related GTC activities. The BPO will collaborate with the GTC team on developing overall trade compliance strategy; further shape the strategy into repeatable scalable business processes and systems; functionally own the Global Trade Management (GTM) system and technology including interfaces with Vertex ERPs and other systems to support these processes; and act as a GTC Project Manager for process...

Use Your Power for Purpose Seeking a detail-oriented person to work with members of the Quality Stability Program Management team to support the design, development, implementation and maintenance of stability protocols and studies for a commercial product and a variety of late phase clinical products both internal and at external manufacturing facilities. This position will include the comprehensive review and assessment of stability data (including trending and analysis), providing quality stability reports suitable for regulatory submission, and authoring stability sections of regulatory documents in support of IND's, BLA's, PMA's, MAA's, etc. In addition, the candidate may be required to represent...

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. Join us at Medtronic’s Boulder, Colorado facility - a dynamic hub for surgical innovations within our Medical Surgical portfolio. As a Supplier Quality Engineer II, you’ll play a pivotal role in advancing Medtronic’s mission to alleviate pain, restore health, and extend life for...

The Supplier Quality Engineer II will support Medtronic’s Brooklyn Park site by partnering closely with suppliers and internal stakeholders to ensure quality, compliance, and continuous improvement across the supply base. This role is responsible for supplier qualification, performance monitoring, and issue resolution, while driving corrective and preventive actions aligned with regulatory and quality system requirements. The ideal candidate brings strong technical judgment, a collaborative mindset, and a passion for delivering high‑quality products that ultimately improve patient outcomes. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable...

Senior Specialist , Quality Control Analytical , Cell Therapy Role Overview The Senior Specialist, QC A nalytical , provides operational and technical leadership for a cGMP Quality Control laboratory supporting cell therapy lot release and stability. The role focuses on right ‑ first ‑ time analytical assay execution (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell ‑ based assays) and end ‑ to ‑ end laboratory readiness, including people and equipment oversight . Responsibilities span routine testing execution, laboratory operations management, quality record management , and audit/inspection readiness. The Senior Specialist partners closely with other QC teams...

Key Responsibilities Global Quality Project & Portfolio Management Own and maintain Global Quality project portfolios , ensuring visibility, alignment, and execution across the network. Monitor project progress, proactively manage risks and dependencies, and ensure initiatives are delivered on time and within scope . Drive end‑to‑end planning and execution of global quality initiatives, including detailed project plans, timelines, milestones, and resource management. Collaborate closely with Project Leads and Quality Leadership to track progress, manage risks, and communicate outcomes across the organization. Quality Systems Enablement & Integration Capture, prioritize, and manage Quality Systems enhancements and platform integrations , ensuring timely and effective...

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

This position will be responsible for the leadership, oversight and direction for the regulatory review function of US Office of Promotion and Advertising Review (OPAR) . This role has ad/promo regulatory review accountabilities across all Therapeutic Areas of our company's portfolio in the US. This role will manage a team of reviewers and supporting roles to set the strategic direction for a staff of 30+ professionals. This executive leadership position has Strategic Responsibilities Regulatory Guidance Interpret and apply advertising and promotion regulations in reviews. Proactively design risk mitigation that anticipates the evolving regulatory landscape and allows for aggressive yet...

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. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO 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 bachelor’s degree. A company recognized as a great place...

We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN or Plano, TX. This position performs three 1-year rotations that include specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. Additionally, during certain rotational periods the position may be responsible for regulatory operations activities such as logistics management of global product release, and maintaining tools needed for managing global regulatory...

Job Title Quality Engineer 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,...

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

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 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...

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 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...

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

Job Profile Summary The Quality Engineering Service Manager for Worldwide TechServ will be responsible for managing all Compliance and Quality aspects across multiple global service and depot centers. This role ensures adherence to regulatory requirements, internal standards, and continuous improvement initiatives within a highly complex and evolving environment. - Support Quality & Compliance Strategies for Worldwide Tech Serv operations across multiple regions. -Act as the primary Quality point of contact for Worldwide Tech Serv leadership. -Ensure compliance of service centers and depot centers globally with global regulatory standards and internal policies. Provide direct oversight for regions USA, EMEA, China,...

Responsible for supporting Quality Control testing for in-process, final product, and stability samples. May assist with documentation, deviations, investigations, and continuous improvement efforts. · Perform routine testing of in-process, final product, and stability samples. · May review GMP documentation and perform data verification. · Support document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts. · May train analysts on general job duties. · Perform other tasks as assigned. · This position will report to QC management. Specific Knowledge, Skills, Abilities · Ability to accurately and completely understand and follow procedures. · Apply scientific principles to...

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

R&D Quality, Audit Strategy Operationalize and execute the risk-based audit and quality strategy across Therapeutic Areas, R&D processes, investigator sites, vendors, and digital health aligned with ICH E6(R3), regulatory expectations, and company objectives Lead the planning, conduct, and reporting of audits and assessments, ensuring consistency, quality, and timely delivery, in partnership with Clinical Auditing team, Development Quality and business stakeholders Identify, assess, and escalate quality risks, contributing to trend analysis, metrics, and evidence-based insights Support continuous improvement initiatives by translating audit and inspection findings into actionable corrective and preventive actions, monitoring audit trends and identifying emerging risks Support implementation of...

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

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...

Johnson & Johnson is currently recruiting for an Innovative Medicine Transformation IT Compliance Senior Manager (Transcend Program) and the role will be based in Titusville, NJ. 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...

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...

This role will be based at Medtronic’s North Haven, Connecticut campus—a flagship U.S. research, development, and manufacturing site with a long-standing legacy in advanced surgical technologies and medical devices. The North Haven site is a key hub within Medtronic’s Surgical Operating Unit and plays a critical role in developing and manufacturing innovative products that support patient care worldwide. The individual in this role will work closely with the North Haven Environmental, Health, and Safety (EHS) team and will be responsible for administering and implementing environmental compliance programs in alignment with federal, state, and local regulations, as well as Medtronic corporate...

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. The Senior Director - Counsel, Clinical Development will be part of...

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

The Manager, Regulatory Affairs Device , works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for global regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision. Build and maintain relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA Device on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations. Responsibilities Prepares device regulatory product...

The Manager, Regulatory Affairs Device , works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for global regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision. Build and maintain relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA Device on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations. Responsibilities Prepares device regulatory product...

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 on-body delivery systems, pre-filled syringes, auto-injectors, 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,...

Job Summary Vertex is seeking an experienced Associate Director, Quality Control to provide strategic and operational leadership for commercial Cell and Gene Therapy (CGT) programs supported through external manufacturing and testing partners. This role is accountable for QC oversight of CMOs and CTLs, people leadership within the External Manufacturing QC organization, and sustained inspection readiness for commercial supply. The successful candidate will lead teams responsible for external QC oversight, drive resolution of complex quality and technical issues, and ensure continuous improvement in compliance, efficiency, and performance across the external network. Key Responsibilities Provide strategic QC oversight for commercial CGT external...

Senior Specialist, Metrology and Validation, Pharmaceutical Analysis & Digital Technologies The Pharmaceutical Analysis & Digital Technologies (PADT) External Capabilities, Validation, and Compliance (ECVC) department of our company's Research Laboratories Division is seeking applicants for an Metrology and Validation Specialist position available at the West Point, Pennsylvania research facility. The Metrology and Validation Specialist will work as part of the integrated US Metrology and Validation team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The role oversees and supports the onboarding, qualification, validation, and routine maintenance of analytical equipment...

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. The Associate Director – Quality Assurance - Operational Readiness is a...

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

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. We are looking for a Senior Manager to join our Compliance Excellence & Innovation Partners (CEIP) team, which plays a critical role...

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

This position is located in Lafayette, CO and supports the Acute Care & Monitoring (ACM) operating unit. The Regulatory Affairs Program Manager (RA Program Manager) provides regulatory program leadership for OEM and ACM distributed Medtronic brand products within the ACM Operating Unit. This role is responsible for planning, coordinating, and driving regulatory activities across OEM programs, while partnering closely with internal Regulatory Affairs teams to ensure global regulatory strategies and registrations are aligned, executed, and sustained throughout the product lifecycle. Position requires to be onsite 4 days per week in our Lafayette, CO location. Responsibilities may include the following and...

Join our collaborative team at our manufacturing site in Plymouth, MN to put our patients first through ensuring compliance in everything we do. In this role as a Senior Quality Systems Specialist, you will ensure compliance with Medtronic policies, FDA regulations, ISO 13485, and other requirements. You also will provide guidance and mentorship on CAPA processes and tools, such as root cause analysis, and participate in both internal and external audits and inspections. Additionally, you will support the Quality Management System by performing continuous improvement activities and ensuring that processes are compliant to regulations as well as meeting the needs...

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

Supervisor Quality Control This position works out of our San Diego, CA location in the Cardiometabolic and Informatics (CMI) , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Supervisor Quality Control supervises the activities, manpower and resources within the Inspection area to ensure support is provided to meet the department and company goals. Responds to complaints on parts, and work orders, plans and...

Job Title Senior Quality Engineer This position works out of our Plano, TX location in the Neuromodulation division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. The Senior Quality Engineer provide hands-on Quality and Process Engineering leadership to manufacturing operations, ensuring consistent delivery of the highest-quality products to customers. This role carries direct supervisory responsibility and serves as a key quality leader on the production floor, driving compliance, continuous improvement,...

At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as an Experienced Engineer Manufacturing Quality, to be located in Danvers, MA . 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 In this role, you will have the unique opportunity to contribute to the manufacturing of life-saving medical devices. As part of our "Patients First!" culture, you will play...

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 Ready to lead at the forefront of innovation? Learn more and apply today! The role will drive the development of strategy for Computerized System Validation aligned to site and global standards as well as to the industry best practices. The incumbent is...

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

At Alexion, Rare Disease everything we do is underpinned by our dedication to being a Great Place to Work. Put simply, our people are our greatest asset. We know that with a talented, brave and diverse team that believes in making a meaningful impact for people living with rare diseases, every day – incredible things happen. At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives. This is...

This is a seasoned individual contributor role responsible for developing, implementing, and maintaining rigorous quality standards and protocols during the sustaining and post-market phases of the product lifecycle. The Specialist serves as a key technical expert, working with limited supervision, who must demonstrate substantial expertise in risk management (e.g., assessing product risk and supporting field actions). This role involves providing design-quality oversight for product changes (including design change analysis and DHF maintenance), and using advanced inspection, testing, and statistical analysis methods to ensure product precision, accuracy, and compliance with all required standards and documentation. A successful candidate will drive process...

Senior Associate Quality Assurance What you will do Let’s do this! Let’s change the world! The Sr. Associate QA will be a member of the Amgen Thousand Oaks Clinical Final Drug Product QA team. Must have experience with GMP processes and documentation. Without that fundamental skillset the training for document review tasks, label approval and packaging inspection will have no foundation. The Sr. Associate QA must be able to methodically and meticulously inspect printed materials for print quality defects, clinical product components (e.g. syringes and vials) for physical defects, and batch record documentation for accuracy and completeness. Must be able...

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

Associate Quality Control What you will do and what we expect of you In this vital role you will Duties Assist execution of equipment installation and qualification within the microbiology lab to support start-up; Support document review and authoring, including standard operating procedures, safety assessments, methods, trend reports, microorganism assessments, and technical reports; Assist with execution of Environmental Monitoring Performance Qualification activities to support establishment of environmental monitoring program; Perform routine environmental monitoring and utilities sampling; Perform routine quality control testing, including Bioburden, Endotoxin, Microbial Identification, Polymerase chain reactions, and total organic carbon; Participate in audits, initiatives, and projects...

The Senior Quality Engineer is responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations. Responsibilities Perform QA activities related to Combination Product and Medical Device Development Ensure compliance with company policies and procedures. Perform design control and risk management activities according to AbbVie's Quality System Partner within Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met Perform 3rd party supplier management...

The Senior Quality Engineer is responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations. Responsibilities Perform QA activities related to Combination Product and Medical Device Development Ensure compliance with company policies and procedures. Perform design control and risk management activities according to AbbVie's Quality System Partner within Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met Perform 3rd party supplier management...

The Director, Regulatory Affairs, U.S. Regulatory Policy & Intelligence (RPI), utilizes knowledge of the scientific, regulatory, and business environment regarding how medicinal products and medical devices are developed, evaluated, authorized and monitored once marketed to support and guide product development strategy. Develops and maintains strong partnerships with regional area and affiliate staff that interact with Health Authorities (HAs). Monitors external environment for evolving policies that impact product development, lifecycle maintenance and on-market support working closely with Subject Matter Experts (SMEs) to analyze impact. Establishes, develops, and maintains relations with HAs and peer companies, industry trade associations, and external organizations regarding...

The Senior Quality Engineer is responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations. Responsibilities Perform QA activities related to Combination Product and Medical Device Development Ensure compliance with company policies and procedures. Perform design control and risk management activities according to AbbVie's Quality System Partner within Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met Perform 3rd party supplier management...

Technical expert that will independently identify, engineer, and optimize new data, software, or technology solutions that address critical business needs. Works with QA Lab Business Owners and the broader BTS organization to improve existing methods and processes. Read and adapt literature and publicly available information to accomplish assignments. Demonstrate proficiency in a broad range of techniques and methods for information technology engineering, including software development, data warehousing, statistics, machine learning, and/or technology infrastructure. Responsibilities Independently design and develop data, software, or technology solutions to answer scientific or business questions. Demonstrate proficiency across a range of technologies related to programming languages,...

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and...

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and...

Johnson & Johnson is currently seeking a Manager, JJEI Quality Risk Management to join our team located in Raritan, NJ, Spring House, PA, New Brunswick, NJ, or Titusville, NJ, with considerations given to alternate US based J&J sites at the discretion of the business. 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...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Senior Principal Quality Engineer – Design Quality & Systems Excellence role to be located at Danvers, MA. ABIOMED is redefining team-driven success while reshaping heart recovery. Here, new ideas are welcomed and encouraged, learning is constant, and our dynamic setting enables positive people to do profoundly important work. At Johnson & Johnson, we believe...

Your skills could be critical in helping our teams accelerate progress. As the Director, US Regulatory Affairs - Advertising and Promotion, you'll partner with other key functional teams to ensure materials are consistent with US regulations, company policy and industry guidelines. You'll be asked to solve problems creatively and strategically, and introduce innovative concepts to more effectively manage ad/promo projects. This is a subject matter expert role wiht no direct reports, though there will be mentoring, training and team leadership opportunities. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s...

As Regulatory Affairs CMC Project Lead within our R&D team , you will serve as a strategic regulatory expert who coordinates multiple cross-functional projects, provides senior-level CMC regulatory guidance, mentors team members, drives accountability for deliverables, and influences decision-making while ensuring regulatory compliance and alignment within Sanofi's "Take the Lead" values. This role offers a dynamic opportunity at the intersection of regulatory expertise and innovative drug development. As part of this pioneering function, you'll provide strategic regulatory leadership across multiple projects, leveraging cutting-edge AI and digital platforms to accelerate development timelines. Working collaboratively with cross-functional teams, you'll influence critical decisions...

In this exciting role as the Senior Quality Systems Specialist, you will use data analysis skills and CAPA experience to support the quality function completing audits at the Mystic, CT facility. 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...

QA SR MANAGER EXTERNAL SUPPLY QUALITY (ESQ) - SUPPLIER QUALITY MANAGEMENT What you will do In this vital role you will serve as the quality lead and subject matter expert for critical global suppliers of GMP raw materials, specifically Single Use, Resins, and Filters (SURF). You will own the end-to-end quality oversight of assigned suppliers—from onboarding through ongoing performance monitoring to disengagement—ensuring compliance, reliability, and continuous improvement. You will also act as the primary quality contact for internal stakeholders, supporting issue resolution, supplier strategy, and cross-functional initiatives. This role offers a unique chance to make a global impact while...

Quality Assurance Senior Manager What you will do In this role of Quality Senior Manager you will be responsible for quality oversight of multiple secondary packaging components external suppliers which provide global goods and services to Amgen. You will be part of a multifunctional team and work within the Quality organization to ensure appropriate scientific, regulatory, and quality standards are followed to assure product quality and compliance. You will work closely with External Supply, Process Development, Combination Product Quality, and various other parts of Operations. This role also has regional responsibilities across multiple manufacturing sites. The Quality Senior Manager...

This is not a remote opportunity Qualified candidates must currently live in the Chicagoland area. What You’ll Work On Individual contributor that works under limited supervision. Applies subject matter knowledge. Requires capacity to understand specific needs or requirements to apply skills/knowledge. Primary responsibility is ensuring implementation of quality plans at every stage of the manufacturing process. Implement quality assurance regulations. Write and revise standard operating procedures. Support and facilitate audits and regulatory inspections. Ensure that standards are met and report potential issues either with quality or reliability of testing procedures. Visually and dimensionally testing of sampling material Required Qualifications Minimum...

Job Title Sr. Supplier Development Quality Engineer We currently have an opening for a Sr. Supplier Development Quality Engineer for the CRM division. This role can be located at our Sylmar, CA location. As a global leader in Cardiac Rhythm Management, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. What you’ll do Assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety 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. About Lilly Eli Lilly and Company is a global pharmaceutical leader...

DePuy Synthes is recruiting for a Director, FM Risk & Compliance. This Hybrid position will be located in Raynham, MA, West Chester, PA, Warsaw, IN, Palm Beach Gardens, FL or Loughbeg, Ringaskiddy, Ireland. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) US - Requisition Number R-072512 Ireland - Requisition Number R-073610 Remember, whether you apply to one or all...

Responsibilities Sets up, leads and develops a team responsible for Quality Control Coordination, Quality Compliance, Exception and Change Management, Qualification and Maintenance and, analytical Outsourcing. Develops and implements short and mid-term strategy for the Compliance group and manages effectively local and global interfaces (within PDS&T, with Operations QC, R&D and Ops QA, Development Sciences, Regulatory, etc.). Develops/aligns local processes/workflows and GMP approaches within PDS&T LC Develops/aligns in close cooperation with other PDS&T sites and partner organizations global lean processes/workflows and GMP approaches cross-functionally. Manages effectively local/global interfaces (Operations QC, R&D and Ops QA, Development Sciences, Regulatory, etc..) and drives cross-functional...

The Senior Manager, IT Quality is responsible for elevating AbbVie’s IT operations and software quality practices by ensuring full compliance with regulatory requirements and corporate standards, while providing advanced strategic leadership across process improvement, risk management, and validation strategies. This role leads the development and implementation of quality systems and processes by leveraging digital enablement, data-driven methodologies, and emerging technologies including automation, AI, and advanced analytics. Collaborating directly with cross functional teams, the Senior Manager provides audit and inspection support, Corrective Action and Preventive Action execution in the Business Technology Solutions Quality area, and adoption of vendor documentation, strengthening operations...

The Associate Director, Customs Valuation Compliance & Reporting, is a critical compliance role that actively partners across the enterprise and leads the operations and strategic design of the end-to-end customs valuation and reconciliation process. Responsibilities include leading the financial planning and reporting of customs tariff impact to AbbVie’s imports (primarily focused on the Americas region) by conducting relevant variance analyses, scenario modeling and developing executive-ready reports; leading customs valuation initiatives in collaboration with stakeholders from other departments; and ensuring accuracy and predictability of tariff costs and other customs reporting metrics. Responsibilities Ensure compliance with U.S. Customs and Border Protection laws...

Responsible for assisting with the internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards. Responsibilities Assists with planning and conducting internal compliance audits of all operations within the facility. Helps the team to become more proactive in preparing for audits. Provides support with company and regulatory agency (i.e. DEA, FDA) inspections. Follow up on audits to assure that action plans are developed and completed in a timely fashion. Assist with management review and associated metrics for the plant. Creates compliance performance metrics. Provides support...

The Director, Regulatory Affairs Advanced Technology Enablement is responsible for shaping, owning, and executing the Regulatory Affairs (RA) AI roadmap, driving strategic initiatives that embed artificial intelligence and automation within the global RA organization. This leader will serve as the key subject matter expert for regulatory AI, guiding the practical and future-focused application of AI technologies to enhance regulatory efficiency, enable organizational transformation, and foster a culture of innovation. The Director will actively bridge enterprise-level AI directives into actionable RA strategies, partnering closely with Communications & Change Management and Training teams to ensure effective knowledge transfer, change enablement, and continuous...

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. This...

The Associate Director, International Regulatory Affairs Advertising & Promotion safeguards products and practices to adhere to the highest quality and regulatory standards. The Associate Director will design and deliver optimized global regulatory strategies, plans and dossiers that align with AbbVie’s overall business strategy. This individual is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds. The Associate Director will interface with International Marketing, Global Legal and Office of Ethics...

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...

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. The Senior Director, Regulatory Affairs Strategy is a senior individual contributor and people leader responsible for shaping, influencing, and executing global regulatory strategies across one or more complex development programs. This role serves as a critical bridge between program-level execution and portfolio-level strategic alignment. The Senior Director will provide deep regulatory expertise, lead health authority interactions, mentor regulatory...

Location Raritan, New Jersey, West Chester, Pennsylvania, Palm Beach Gardens, Florida, Raynham, Massachusetts, Warsaw, Indiana DePuy Synthes is recruiting for a(n) Sr. Manager, Regulatory Affairs . Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics 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...

DePuy Synthes is recruiting for a Sr. Director, Regulatory Law, located in Raynham, MA, New Brunswick, New Jersey, West Chester, Pennsylvania. Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed sometime in 2027, 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...

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....

DePuy Synthes is recruiting for a Supervisor, Quality/Compliance . This Hybrid position will be located in Raynham, MA (USA). Alternate Hybrid locations maybe considered at Raritan, NJ (USA); West Chester, PA (USA); Palm Beach Gardens, FL (USA). Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics 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...

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,...

The Associate Director, GMP Operational Quality is responsible for quality oversight of QC data review for both non-routine and routine cGMP process testing and in support of stability testing of Cell & Genetic Therapy products. The role will also oversee team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates...

We are seeking an experienced, detail-oriented Associate Director to join the Biologics Pilot Plant (BPP) Operations team within Vaccines and Advanced Biotechnologies Process Research and Development (VAXPR&D). In this role you will lead, author, document, and drive formal investigations of process deviations, non-conformances, and incidents to determine root causes and ensure compliance with regulatory requirements and internal standards. You will partner closely with process development, manufacturing, and quality colleagues to implement corrective and preventative actions, support investigation governance, and improve operational robustness across upstream and downstream pilot operations. The position will be temporarily based in West Point, PA for approximately...

This position is located in Lafayette, CO and supports the Acute Care & Monitoring (ACM) operating unit. The Principal Regulatory Affairs Specialist (Pr. RAS) provides regulatory leadership and strategic direction for the Core Respiratory product portfolio within ACM. This role is responsible for collaborating with cross-functional partners to develop, plan, and execute global regulatory strategies across early development, commercialization, lifecycle management, and business transition activities. This position is suited for a high-performing individual contributor who operates with a high degree of autonomy on moderately to highly complex programs. With limited supervision, the Pr. RAS sets objectives aligned with broader business...

Schedule This onsite position operates on 10-hour shifts from Sunday through Wednesday during the first shift (8AM-6PM), with some occasional support required outside of those hours. About This Role We are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at RTP drug substance manufacturing facility. The Sr. Associate I is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Associate I performs and trains other team members on the microbial testing of all in-process drug substance, EM/UM, and raw materials samples. Additionally this...

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

The Robotics and Digital solutions (RAD) group, part of the Johnson & Johnson family of companies, is recruiting for a Staff Image Quality Engineer. This position is located in Santa Clara, CA. Robotics and Digital Solutions, is part of Johnson & Johnson Med Tech. At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms...

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...

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

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

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...

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...

As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs. Your Role You will serve as CMC-regulatory lead for assigned projects. Develop and execute CMC global submission plans and timelines in accordance with project goals You will lead the preparation/plans, review, and on-time submission of CMC sections for IND/IMPD/CTA, NDA/MAA and other global regulatory filings including IB, DSUR, annual updates, briefing books etc. in conjunction with regulatory affairs and CMC/Pharmaceutical Development leads/SMEs. You will be responsible for coordination of responses to CMC...

Quality Manager, Portfolio Expansion This position works out of our Columbus, OH location in the Nutrition Division . This position is responsible for supporting the expansion of Abbott Nutrition (AN’s) Third Party Manufacturer (TPM) portfolio through all stages of qualification. This requires collaboration with cross-functional personnel to lead and actively support activities through TPM selection, evaluation, approval, and first commercial run. The position also acts as the main AN Quality point of contact during the entire qualification process. This requires establishing a robust long-term working quality relationship with the TPM and ensuring that start-up project activities are carried...

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...

Corporate Facilities and Engineering Quality Manager What you will do In this vital role you will be responsible for ensuring compliance and operation excellence within the Global Facilities Operations organization. You will also use data analytics to drive process improvements and alignment opportunities. Activities include Coordinates, leads, participates and responds in internal and external audits from Quality and regulatory agencies in facility scope managed by integrated service providers. Assists with audit programs and activities, ensuring relevant data is correct and available, when necessary. Assesses state of compliance with appropriate integrated service provider quality leads and form action plans to...

We are searching for the best talent for an Innovation Excellence Quality Engineer to be based in Danvers, MA. 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 Purpose This person will have the opportunity to perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products! Activities will include risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support statistical analysis...

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

As US Regulatory Strategist in the Innovation Franchise Therapeutic Area - General Medicines GBU within our R&D team , you will serve as a key member of the Global Regulatory Team (GRT) and strategic partner to the Global Regulatory Lead (GRL). You will leverage your regulatory expertise to contribute to the definition of the global regulatory strategy and drive the execution of aligned US or global regulatory strategies for projects under development, including Health Authority interactions. In this role, you will provide regulatory expertise and guidance on procedural and documentation requirements to cross-functional teams, contribute to the development of a...

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

Join a Culture of Collaboration and Innovation. The Opportunity The Medtronic Mindset calls on leaders to act boldly, move with urgency, collaborate effectively, and deliver results—the right way. At Medtronic, our most impactful leaders are those who step into complexity, set clear direction, and elevate teams through strong communication, accountability, and purpose. We are seeking a hands-on Supplier Quality Engineering Manager to lead a critical turnaround at our Grand Rapids, MI manufacturing site. This role is designed for a proven people leader who brings energy, decisiveness, and a track record of driving results through others. The successful candidate will quickly...

Position Senior Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am-6pm) Manager Manager, Quality Assurance Shop Floor The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position will oversee and partner with operational areas to ensure GxP compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. In the capacity of QA Shop Floor, the Senior Specialist shall serve as one of the Quality Representatives interacting with Manufacturing, Supply Chain, Quality Control and other supporting functions. The...

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

Thank you for considering a future opportunity with our company! We are not currently hiring for this specific role, but we would love to connect with talented individuals who are interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise. In this talent pipeline requisition, we are not actively recruiting for this position at the moment. However, we are building a network of exceptional individuals who possess the skills and experience required for future openings. By submitting your application to this requisition, you will be added to our...

The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant. The Senior Quality Engineer will provide Quality support for projects related to core production, new software/computer systems, new products/technologies/Automation systems. As part of the project team, the Senior Quality Engineer will ensure all activities including Qualification/Validation Strategy, Deviation Investigation and Resolution, Risk Management activities, etc. meet applicable Quality and Regulatory requirements. Additionally, the Senior Quality Engineer supports on-going production including by working with operations/quality teams for deviation resolution, auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation...

Purpose Assumes ownership of the Office of Ethics & Compliance (OEC) Business Requirements management processes, including Jira (IT development task management system) and Compliance Demand Generation, in support of the OEC’s Global Strategic Solutions (GSS) program. Responsible for analyzing, refining, and translating stakeholder requirements into actionable opportunities for global analytics program improvement and AI enablement. Integrates GSS compliance programs with broader compliance initiatives and systems. The manager performs the following with moderate to significant supervision from the Compliance Director Responsibilities Assumes end-to-end ownership of Jira (IT development task management system) and the Demand Generation process, managing the intake, prioritization, and...

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and...

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

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

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and...

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

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

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and...

The Senior Quality Engineer, Risk Management has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending,...

The Manager Regulatory Affairs US Advertising & Promotion, combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The Manager is responsible for 1-2 of the following therapeutic area, products or multiple driver indications for a product; develops and supervises regulatory professionals as needed. The Manager has department/group/site level influence and is generally recognized as an expert and resource within the department; supports the Director in efforts to influence the regulatory environment; shares knowledge and expertise with others in support of team activities; and analyzes broad scope implications of...

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

The QA Validation Analyst/Engineer is responsible for planning and overall approval of validation tasks. Responsibilities may also include executing validation activities. Under the direction of the Validation Section Manager, this individual will participate in the implementation of the Validation quality program at the plant under minimal supervision. Level of responsibility and performance is commensurate with grade level. The Validation Engineer responsibilities may include the review of commissioning and validation documentation completed by others, leading, authoring or reviewing investigations and implementation of preventive and corrective action, review and authoring of plant standard operating procedures, review and approval of critical planned maintenance...

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

Lead AbbVie's global Regulatory Policy & Intelligence function, overseeing Senior Director and Director-level leaders. Set strategic direction, drive organizational awareness and alignment, and ensure proactive, compliant engagement with evolving regulatory environments governing medicinal products and medical devices. Serve as executive sponsor and internal/external ambassador to influence worldwide regulatory and policy standards. Set vision and strategy for AbbVie's Regulatory Policy & Intelligence portfolio, ensuring alignment with business goals and compliance obligations. Lead, coach, and develop a high-performing team of Senior Directors and Directors, fostering cross-functional collaboration and talent development. Oversee monitoring and analysis of global regulatory landscapes, anticipating trends and guiding...

The Manager Regulatory Affairs US Advertising & Promotion, combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The Manager is responsible for 1-2 of the following therapeutic area, products or multiple driver indications for a product; develops and supervises regulatory professionals as needed. The Manager has department/group/site level influence and is generally recognized as an expert and resource within the department; supports the Director in efforts to influence the regulatory environment; shares knowledge and expertise with others in support of team activities; and analyzes broad scope implications of...

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

The Manager Regulatory Affairs US Advertising & Promotion, combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The Manager is responsible for 1-2 of the following therapeutic area, products or multiple driver indications for a product; develops and supervises regulatory professionals as needed. The Manager has department/group/site level influence and is generally recognized as an expert and resource within the department; supports the Director in efforts to influence the regulatory environment; shares knowledge and expertise with others in support of team activities; and analyzes broad scope implications of...

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

Lead AbbVie's global Regulatory Policy & Intelligence function, overseeing Senior Director and Director-level leaders. Set strategic direction, drive organizational awareness and alignment, and ensure proactive, compliant engagement with evolving regulatory environments governing medicinal products and medical devices. Serve as executive sponsor and internal/external ambassador to influence worldwide regulatory and policy standards. Set vision and strategy for AbbVie's Regulatory Policy & Intelligence portfolio, ensuring alignment with business goals and compliance obligations. Lead, coach, and develop a high-performing team of Senior Directors and Directors, fostering cross-functional collaboration and talent development. Oversee monitoring and analysis of global regulatory landscapes, anticipating trends and guiding...

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. Eli Lilly RTP is a new state of the art Parenteral,...

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Our location in Sylmar, CA , currently has an opportunity for a Staff Engineer, Customer Quality. WHAT YOU'LL DO The Staff Engineer, Customer Quality is responsible for understanding and representing the customer experience for...

Senior Technology Specialist, Veeva Quality Vault Location Lawrenceville, New Jersey At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology, and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. The primary focus of this role is the delivery of the Veeva Quality Vault portfolio and operational sprints. A secondary focus will...

Job Title External Quality Small Molecule Americas Lead Job Purpose This position is responsible is for the Quality oversight of assigned Contract Manufacturing Organisations (CMOs) in an External Manufacturing specific Region to ensure MAH’s product quality, compliance and reputation is protected. This role will be accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned CMO(s) and with internal stakeholders. These include Procurement, Technical, Supplier Relationship, Regulatory, Business Development, Production, Site Management and other related GSK functions. Key Responsibilities Lead Quality Agreement negotiations with CMOs and implement Quality Systems performance management,...

Johnson & Johnson MedTech is recruiting for a Quality Engineer , located in San Angelo, Texas . 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 In collaboration with Operations and Engineering functions the Quality Engineer will be responsible for ensuring production of safe and effective products, while maintaining health authority and regulatory compliance. Key Responsibilities Partners with business stakeholders using Quality Engineering tools to support new product development and sustain...

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...

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...

As the Senior Manager, Regulatory Affairs Advertising and Promotion within our GRA Advertising and Promo Team, you will be responsible for conducting the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns. Ready to get started? With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. As the product A&P expert, contribute to the development and implementation of...

Bristol Myers Squibb es un empleador que brinda igualdad de oportunidades. Las personas que apliquen para cualquier vacante, y que estén calificadas para la misma recibirán consideración para el empleo sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, nacionalidad, edad, discapacidad, condición de veterano protegido, embarazo, ciudadanía, estado civil, expresión de género, información genética, afiliación política o cualquier otra característica protegida por la ley. De acuerdo con las Buenas Prácticas de Fabricación (BPF) vigentes en Argentina, alineadas principalmente con la Disposición ANMAT 2819/2004 y su actualización Disposición ANMAT 3827/2018 – Guía de BPF, así como con...

Position Overview The Technical Business Analyst serves as a vital link between Digital Technology teams and business stakeholders, ensuring that business needs are accurately translated into effective technical solutions. This role involves guiding moderately complex technology initiatives, with a strong emphasis on delivering impactful business outcomes and exceptional user experiences. The ideal candidate will have the capability to contribute to and drive mid-scale digital programs from concept to execution. Working closely with business partners, the Technical Business Analyst is responsible for gathering, analyzing, and clearly communicating requirements to ensure that digital solutions align with strategic goals and meet the expectations...

Job Title Manager, Quality This position works on site out of our Plano, TX site supporting the Neuromodulation division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. The Quality System Manager is responsible for developing, maintaining, and continuously improving the company’s Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable global regulatory requirements. This role serves as the quality system owner and...

Director Quality Assurance Responsibilities The Director Quality Assurance is r esponsible for ensuring the quality of licensed and clinical products manufactured at the facility. Oversees teams focused on quality oversight of day-to-day site operations, raw material release and drug substance lot disposition. Responsible for ensuring the quality of licensed and clinical products manufactured at the facility. Provides leadership and guidance to other functional areas in areas of regulatory compliance, quality practices, and quality systems. Communicates company goals, safety practices, and deadlines to the team. Motivates team members, provides guidance and leadership, assesses performance, and helps with the development of direct...

Specialist II Quality Control Must be available to work - Wednesday through Saturday, 2PM to Midnight Responsibilities Good organizational skills, basic first-line management skills for daily operation, Situational Leadership, decision making skills Responsible oversight for the testing of raw materials, in process samples, and finished product testing according to standard operating procedures. In-direct supervision of lower level personnel. Investigate and resolve problems. Clear and concise communication to Management. Coordination of tasks to meet assigned schedule Audit support, including presenting information to regulatory agencies, and performing laboratory tours. Coordination of projects and project management. Develops solutions to complex problems requiring ingenuity...

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

Johnson & Johnson is hiring for a Principal Quality Engineer (Design Assurance) to support the Shockwave Reducer business located in New Brighton, MN . Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the innovative Shockwave Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina – long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide. To support the growing Shockwave Reducer business, we are establishing a facility in New Brighton, MN focused...

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....

Associate Vice President, Quality What you will do In this vital role as Associate Vice President, Quality you will report to the Vice President Research and Development Quality (RDQ) Organization (a team of 30-40 staff will be built to serve Amgen’s Research Development Organization). The Associate Vice President, Quality will lead and provide proactive end to end quality strategies globally for therapeutic areas Oncology, Inflammation, Cardiovascular, Neuroscience and others. This role will drive the transformation of clinical quality oversight in compliance with ICH E6R3 and enable embedded quality oversight into clinical development teams. Incorporate quality by design principles to...

The Quality Assurance Specialist participates the day to day management and operations of the facility, products and vendors. Through outstanding communication, effective problem solving, and active management of ambiguous situations, the Quality Specialist 3 ensures safety, quality and compliance with all relevant procedures, state and federal regulations and customer expectations. Ensures smooth and safe operations of the storage facility through stakeholder and vendor engagement. PRIMARY RESPONSIBILITIES Oversight and Ownership of a Quality System (e.g. Change Control Lead including system and board lead) Collecting and trending quality metrics Assistance and leadership in CCRS, CAPAs, Deviations, SCAR, Complaints, and NCRs and filing...

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

This position works out of our Plymouth, MN location in the Electrophysiology Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Performs visual, dimensional and functional inspection and testing according to documented policies and procedures. Records inspection and test data as prescribed by written instructions and procedures. Operates all associated test and measurement equipment as instructed and as documented in procedures. Recommends changes to policies and procedures. May prepare and submit change requests....

We anticipate the application window for this opening will close on - 2 Jul 2026 Position Sr. Design Quality Engineer for Covidien, LP (a Medtronic company), Perform Quality engineering activities in support of new product development. Work cross-functionally to review requirements and identify and assess product risks, and mitigation strategies, as well as review protocols and reports to support product validation. Support Systems NPD Quality team in performing engineering analysis to ensure design quality, analyzing system, and sub-system risk, technical writing, resolving high-profile quality issues, and product improvements for robust design. Utilize Medical device design controls, product risk files,...

The Senior Engineer (2nd Shift) in our Company's Research Labs (Pharm Ops Engineering) provides engineering and compliance support for the FLEx (Formulation, Laboratory & Experimentation) Center in Rahway, NJ. This role supports non‑sterile process equipment and utilities used in the manufacture of oral solid dosage (OSD) products across clinical, developmental, and commercial programs. The position operates with minimal supervision and serves as a key technical and compliance resource during second‑shift operations. Education Bachelor’s degree in engineering with a minimum of 5 years of experience supporting pharmaceutical manufacturing operations for oral solid dosage (OSD) formats Required Experience and Skills Demonstrated commissioning...

Specialist, Metrology and Validation, Pharmaceutical Analysis & Digital Technologies The Pharmaceutical Analysis & Digital Technologies (PADT) External Capabilities, Validation, and Compliance (ECVC) department of our company Research Laboratories Division is seeking applicants for a Metrology and Validation Specialist position available at the Rahway, New Jersey research facility. The Metrology and Validation Specialist will work as part of the integrated US Metrology and Validation team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The role oversees and supports the onboarding, qualification, validation, and routine maintenance of analytical equipment and instrumentation...

The Pharmaceutical Analysis & Digital Technologies (PADT) External Capabilities, Validation, and Compliance (ECVC) department of our company Research Laboratories Division is seeking applicants for a Validation Specialist position available at either the Rahway, New Jersey research facilities. The Analytical Instrument Validation Specialist will work as part of the integrated Validation and Compliance team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The Analytical Instrument Validation Specialist role oversees and/or supports the validation of novel computerized analytical instrumentation within the GMP environment for multiple sites (Pennsylvania, New Jersey, and Schachen,...

Quality Technician II This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer Technician II, you will support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership...

This is an add position with a special focus on developing clinical strategies and clinical study support worldwide. This individual will also perform other regulatory duties. PRINCIPAL REGULATORY AFFAIRS SPECIALIST – Global Clinical Trial s (High-Risk Devices) Pelvic Health 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 long-term outcomes—helping improve confidence, independence, and quality of...

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. Join Medtronic as a Senior Quality Program Manager – Quality Core Team Member (QCTM) and be at the forefront of transforming lives through advanced medical technology. In this highly visible role, you will serve as the Quality Core Team Member for...

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are currently seeking a Quality Director to join the Quality Team in Wilson, North Carolina. While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both...