Quality & Regulatory Jobs in Pharma & Biotech

Objective / Purpose The Director, Target Validation Sciences will lead a next-generation, automation-enabled assay hub for human disease–relevant target validation. Working closely with the Lab of Tomorrow (Takeda’s lab automation and digitalization initiative), this role will transform how target validation is conducted by integrating advanced 3D disease models, organ-on-a-chip technologies, automation, and AI-enabled data analytics into scalable, decision-driving platforms. This role will contribute to and help shape the scientific direction of target validation across therapeutic areas, modernize workflows through digitalization, and support assay transfer across functions while driving the standardization and centralization of assay platforms, accelerating portfolio progression. Accountabilities Establish...

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...

POSITION SUMMARY Quality Engineer supports the quality system processes of the Natera CLIA laboratories and activities associated with clinical trials. The QE works with senior level QE’s and management to address GCP compliance, supplier issues, non conformances and corrective actions that impact the CLIA laboratory operations. PRIMARY RESPONSIBILITIES Support internal and external audits (GCP sponsor, CLIA/CAP, ISO 13485) Under limited supervision, collect and trend quality metrics for clinical trials per pre-defined parameters and/or upon request; provide partnered oversight (with QEII or higher) of CAPAs, deviations, and NCRs associated with clinical trials; Write/revise procedures and forms; submit to Document Control and...

The Regulatory Labeling Senior Manager, Rest of World (ROW) is responsible for development and maintenance of product labelling for ROW markets across all therapeutic areas. This includes prescribing and patient information and associated business processes. Key Duties and Responsibilities Provides individual contribution in development, submission, negotiation and approval of ROW labelling. Ensures compliance with labelling governance requirements and associated business processes. Participates in label working groups and representing labelling at labelling governance meetings. Works with Labelling Operations to ensure alignment with Package Component Labelling Provides input into strategy for health authority interactions and advises stakeholders of regulatory labelling requirements regarding...

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,...

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...

Quality Engineer I- 2nd Shift 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. As the 2nd shift Quality Engineer I , you will assure new or modified products conform to requirements and establish compliance with the quality system. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs....

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

Plant Quality Compliance Manager The Plant Quality Compliance Manager leads all plant‑level quality and compliance activities to ensure alignment with GMPs, FDA regulations, and applicable regulatory standards. This role provides leadership to plant teams, ensures effective execution of CAPAs, maintains audit readiness, and serves as the SQF Practitioner and HACCP Coordinator. The position also supports continuous improvement initiatives and elevates compliance risks and trends to plant and divisional leadership. This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies...

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned...

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....

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. Responsibilities Lilly is actively growing its manufacturing footprint globally to meet...

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...

Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions Location US Remote About the role As an Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions, you will p rovide oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business units and affiliates. You will drive a fit-for-use global Quality framework that elevates the capabilities in the business units and the affiliate and enables them to deliver their clinical research and pharmacovigilance-related regulated activities with high compliance and agility. You will also establish and maintain relationships with key stakeholders outside R&D such...

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. In this exciting role as a Quality Technician III supporting the Cardiac Ablation Solutions organization, you will have responsibility for the inspection and testing of returned products as part of the complaint handling process. The Technician will be capable of supporting...

We are looking for a detailed, organized, customer-focused Grants & Donations Compliance Specialist for Medtronic’s Cardiac Rhythm Management (CRM) business, the largest business within our Cardiac & Vascular Group (CVG). In this role, you will serve as the primary liaison among CRM business partners, health care organizations and societies, and the CRM Grants & Donations Committee. In addition, you will serve as a liaison with the CVG field organization regarding the grants and donations process. Conduct prompt, in-depth analyses of funding requests received from health care professionals and related organizations/societies Proactively communicate with requesters and business partners to obtain...

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 on LinkedIn Medtronic CST Onsite At Medtronic, we bring bold...

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 NIGHT shift available, Panama schedule ( 12-hour shift patterns with a 2-2-3 work cycle including weekends and holidays) 6 pm to 6am 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...

The Director, Quality Compliance and Audits (QCA ) reports to the Executive Director, Quality Compliance & Audits and provides strategic leadership and governance for Gilead’s global GMP and GDP audit program. This role leads and develops a team of auditors and ensures consistent, high‑quality audit execution across Gilead’s global manufacturing and supply network, including internal manufacturing facilities, external contract manufacturers, laboratories, suppliers, distributors, and other third‑party partners. The Director is accountable for oversight of the end‑to‑end audit lifecycle, including development and execution of the annual audit plan, and ensures audits are performed as systematic, independent, and objective assessments of compliance...

The Executive Director, Risk and Proactive Quality is a senior enterprise Quality leader responsible for defining, governing, and advancing the global strategy for Quality Risk Management and Proactive Quality across the organization. This role serves as the Global Business Process Owner (BPO) for Risk and has direct leadership accountability for the Change Control, Medical Device & Combination Product Risk, and Proactive Human and Organizational Performance (HOP) global process owners. This leader provides strategic direction and oversight to ensure that risk‑based thinking, proactive quality practices, and human‑centric performance principles are deeply embedded across the Pharmaceutical Quality System (PQS) and operations. The...

The Senior Director, Proactive Human & Organizational Performance (HOP) is a senior global Quality leader responsible for defining, governing, and deploying proactive quality approaches that strengthen human‑dependent processes and system reliability across the Pharmaceutical Quality System (PQS) and operations. This role serves as the Global Business Process Owner (BPO) for Proactive HOP, accountable for global standards, performance management, capability building, and continuous improvement of the Proactive HOP program. The role reports directly to the Executive Director of Risk and Proactive Quality and partners closely with other Quality GPOs, Local and Functional Process Owners, and site leadership teams to embed Human...

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

This is a remote-based position, candidate must be located within the USA Must be available to start work daily by 9AM EST About This Role The Medical Writing Redaction/Regulatory Response Specialist leads and executes redaction activities for clinical documents intended for public disclosure, ensuring compliance with global requirements and supporting Medical Writing in delivering high-quality redacted packages. The role also provides essential support for regulatory responses by organizing background materials, drafting and formatting response documents, coordinating cross-functional reviews, and ensuring alignment with internal standards and health authority expectations. The Specialist reports to the Associate Director of Medical Writing Operations and...

We are seeking a strong Full Stack Developer to join an AI-first, Agile product team supporting Global Regulatory Sciences (GRS). This role will develop and operate AI-native regulatory products, where large language models, agentic workflows, and data-driven intelligence are the default approach to solving business problems—not an add-on. The ideal candidate brings deep, hands-on software engineering experience delivering generative and agentic AI solutions in a regulated environment, with a focus on building production-grade platforms, integrations, and data-connected applications that can scale. Key Responsibilities Rapidly prototype AI solutions, validate hypotheses with users and data, and iterate from proof-of-concept to MVP and...

The Validation Engineer will play a critical role in ensuring compliance with all regulatory requirements and industry standards related to GMP asset management and validation in a regulated GMP manufacturing facility. This position requires a hands-on validation engineer with experience in GMP, an understanding of lab/manufacturing equipment, and a proven track record in validation processes. Key Responsibilities Establish validation protocols, risk assessments, and qualification plans to support GMP operations. Acts as a validation Subject Matter Expert (SME) providing support to multi-function teams, advises operations on validation matters, and potentially serves as the point of contact to present validation programs and...

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

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. 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 regulatory strategies for labeling, product defense, and development projects. Serve as the primary liaison with FDA, for assigned products, on...

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 together. ...

About Cell Therapy In Operations we turn molecules into medicine and are unified in our commitment to deliver more medicines to more patients more quickly. In essence, we are the critical link that brings innovation from our science labs to patients around the world. From our quality labs to commercial manufacturing, we share a common purpose to ensure our high-quality medicines reach patients when and where they need them, with the ultimate goal of improving their daily lives. We’re achieving all of this while continuing to accelerate our operational excellence through innovative science, Lean ways of working, and evolving digital...

Summary The validation engineer 2 works as an integral part of the validation team supporting new product introduction, sustaining manufacturing, computerized system introduction / sustaining. Collaborate in a dynamic team-oriented environment and lead the effort for defining, implementing and maintaining validation for manufacturing processes and systems. Become highly proficient in use of Validation Life Cycle Management System. Key Responsibilities Develops and articulates robust strategies for validation of processes/systems and generate validation plans Develops validation protocols for and oversee execution of IQ, OQ, PQ and manufacturing processes, systems and equipment in collaboration with end users and process owners Writes reports summarizing...

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. Purpose The purpose of the Associate Director / Director, Global Medicines...

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...

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. Defines appropriate measures to ensure product quality. Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. Reviews software systems design, change specifications, and plans against contractual and/or process requirements. Reviews include applicable...

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...

Quality Engineer I This position works out of our Plymouth, MN location in our Structural Heart Division. In Abbott’s Structural Heart (SH) business, our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. As the Quality Engineer I , you will assure new or modified products conform to requirements and establish compliance with the quality system. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. You will support...

Abbott Nutrition in Casa Grande, AZ is seeking a Quality Engineer. The Quality Engineer is involved in all aspects of the manufacturing operation from assessing equipment needs, to documenting installation, qualification, and ongoing validation of equipment and processes. The Quality Engineer is also expected to assist in the identification and resolution of quality related issues and work with other areas to resolve issues. This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult...

Johnson & Johnson is currently recruiting for a Senior Quality Operations Manager! This position can be located in Cornelia or Athens, Georgia. Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinates. At this level, the position has a greater degree of impact on the business results and typically, responsibility for managing a group of professionals. Implement and lead the quality operations organization for the Ethicon Cornelia, Georgia site by Planning, coordinating, and directing quality assurance programs designed to ensure continuous production...

About the role The Strategy Lead (Director) drives strategic planning for GLEC by translating senior leadership priorities into clear, actionable plans and measurable objectives. The role oversees annual planning, maintains strategic roadmaps, manages OKR/KPI frameworks, and supports operating reviews and governance processes. It includes leading strategic analyses, partnering with program and change management teams, and ensuring strong alignment, execution quality, and visibility across teams and regions. The Strategy Lead also serves as a strategic advisor to senior leaders, ensuring the function stays coordinated and focused on enterprise priorities. How you will contribute Lead all core annual planning workstreams, including calendar...

About the role The Learning & Development Lead (Director level) is responsible for creating and executing the global strategy to build both current and future capabilities across the Function. This includes designing an integrated learning roadmap that strengthens functional excellence, supports career development, embeds DE&I principles, and improves manager and team effectiveness. The role partners closely with GLEC Leadership, HR, Talent Development, and DE&I teams to ensure the Function is inclusive, high‑performing, and offers clear pathways for growth and advancement. How you will contribute Develop and own the L&D strategy and multi-year capability roadmap aligned to the Function’s priorities, risk...

Job Title Associate Quality Engineer We currently have an opening for an Assoc. Quality Engineer for the Vascular division. This role is located at our Westford, MA location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. WHAT YOU'LL DO Provide Process/Quality Engineering support to manufacturing and sustaining engineering teams, helping to ensure delivery of highest quality product to the customer. Participate in problem...

The Manager, Quality Assurance is responsible for supporting and maintaining compliance with the Quality Management System (QMS) and applicable regulatory requirements. This role ensures that manufacturing, testing, and release activities for cell therapy products are conducted in accordance with cGMP standards and company procedures. The position provides day-to-day oversight of Quality Assurance activities, supports cross-functional teams, and contributes to risk assessment and continuous improvement initiatives. This role supports operations across the Santa Monica, CA and Tarzana, CA sites and reports to the Director of Quality Site Head. Key Responsibilities Support management of the Quality Assurance team, including training, scheduling, 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. Patients are at the center of everything we do at Lilly....

The Senior Quality Engineer – Combination Products External Quality is responsible for the quality of assigned suppliers/contract manufacturers to ensure business objective are me with regards to on time delivery of product while assuring compliance to AbbVie requirements, applicable external regulations, and standards. Products include injection molded components, and critical device components used to manufacture AbbVie On Body Injection Delivery Systems. Responsibilities Support supplier quality development projects and continuous improvement activities. Investigate/coordinate supplier quality issues resolution with the appropriate department, including the dispositioning of non-conforming product, event, deviation, and market complaints. Initiate and follow up on Supplier Corrective Action...

JOB TITLE Quality Systems Manager LOCATION 50 Northern Ave ., Boston, Massachusetts 02210 OPENINGS 1 DUTIES Collaborate with internal and external business partners and cross-functional teams to resolve complex quality and operational issues, ensuring compliant and efficient solutions. Draft, review, and maintain process-specific Standard Operating Procedures (SOPs) and Work Instructions to ensure they remain compliant and up to date. Analyze workflows, quality systems, and production processes to identify inefficiencies, compliance gaps, and areas for continuous improvement. Develop and implement effective solutions, encompassing enhancements to cross-functional quality systems and operational processes, ensuring adherence to industry standards and regulations...

General/ The Director, Clinical Quality Program Lead (CQPL) is responsible for the quality oversight across a range of study phases within assigned disease area(s) to ensure that trials are conducted in accordance with GCP requirements. The CQPL has oversight of real-time inspection readiness, risk management and quality health of programs in their assigned disease area(s). This position reports directly to the Senior Director of Global Clinical Quality (GCQ) and will sit on the GCQ Leadership Team. This position will have line management responsibilities. Key Duties & Responsibilities Partner with business stakeholders across Global Clinical Operations, Clinical Development, Regulatory, etc. for...

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. This position reports to the Shift Manager, Quality Assurance Shop Floor. This position works a rotating 2-3-2 Panama schedule (6am to 6pm) Day shift. Key Responsibilities Provide Quality on-the-floor oversight to Manufacturing/QC/Warehouse/ Packout operations. Identify departures from approved procedures & responding to complex issues independently and escalating critical issues...

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...

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...

We are searching for the best talent for a Senior Design Quality Engineer I 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...

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 Software Design Quality Engineer role to be located at Danvers, MA. The ideal candidate for the Software Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a role in product risk management, cybersecurity, change controls, and design controls. This engineer should excel in an environment that...

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 Software Design Quality Engineer II role to be located at Danvers, MA. The ideal candidate for the Software Design Quality Engineer II position will support various New Product Development and sustaining activities as well as play a role in product risk management, cybersecurity, change controls, and design controls. The engineer should have the ability...

Employer Medical Device Business Services, Inc. Quality Engineer II Job Code A011.10114.6 Job Location Palm Beach Gardens, FL Job Type Full-Time Job Duties Ensure manufacturing areas are meeting good manufacturing practices, international organization for standardization and any other applicable standards. Support day-to-day manufacturing operations in areas such as nonconformance review and evaluation, process verification and validation, process risk assessments, inspection methodology and acceptance criteria for inspection sample plans, root cause investigations, and collaboration on corrective actions (CAPA). Provide leadership in understanding QSR and ISO 13485 regulations, both within the Quality team and across other departments, and help represent Quality...

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

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

The Cardiac Rhythm Management operating group is a division within Medtronic focused on developing and manufacturing medical devices and solutions for the management of cardiac arrhythmias and heart failure. This group’s product portfolio includes implantable pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, and remote monitoring systems. CRM’s mission is to improve patient outcomes and quality of life by providing innovative therapies for the detection, prevention, and treatment of abnormal heart rhythms. The group collaborates closely with healthcare professionals and leverages advanced technology and data-driven insights to drive improvements in cardiac care. At Medtronic, we bring bold ideas forward...

The Associate Director, Operational Excellence – Internal Quality is a people leader who owns the vision, strategy, and operating model for Operational Excellence across Internal Quality. This role ensures strong strategy‑to‑execution alignment, delivering sustained improvements in compliance, efficiency, cycle time, cost, and right‑first‑time outcomes across Quality Assurance and Quality Control while maintaining inspection readiness and patient safety in a GxP environment. The role serves as the enterprise Operational Excellence leader for Internal Quality, aligning priorities to Quality and enterprise strategy, governing delivery, enabling the OE network, and ensuring measurable value realization across a portfolio of initiatives. This role will sit...

Senior Compliance Manager Strategic Mission The mission of Medical Operations Quality & Compliance (MedOps Q&C) is to be the best-in-class Local Quality organization that enables and empowers the U.S. Affiliate to do what’s right for patients by guiding the business through the medical quality and compliance and healthcare compliance landscape. We achieve this by leveraging our unique business, medical quality and compliance knowledge and fostering broad enterprise collaboration with key organizational partners to navigate the regulatory landscape while promoting a culture of quality and compliance. The Opportunity The Senior Compliance Manager is a specialized strategic advisor and key contributor within...

Senior Compliance Manager Strategic Mission The mission of Medical Operations Quality & Compliance (MedOps Q&C) is to be the best-in-class Local Quality organization that enables and empowers the U.S. Affiliate to do what’s right for patients by guiding the business through the medical quality and compliance and healthcare compliance landscape. We achieve this by leveraging our unique business, medical quality and compliance knowledge and fostering broad enterprise collaboration with key organizational partners to navigate the regulatory landscape while promoting a culture of quality and compliance. The Opportunity The Senior Compliance Manager is a specialized strategic advisor and key contributor within...

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

Director of Project Controls - Capital Planning, Engineering Project Delivery and Compliance What you will do Let’s do this. Let’s change the world! This role is a key leadership position within the Global Engineering Organization, supporting our aspiration to be Front Office for Operations. The Director is responsible for managing Amgen’s capital portfolio, ensuring consistent and compliant project execution, and advancing transformation initiatives aligned with Engineering’s strategic vision. This leader will drive cross-functional collaboration, align business priorities with investment decisions, and promote continuous improvement to maximize value delivery. This position will be located within driving distance from Amgen sites in...

Quality Engineer I 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. As the Quality Engineer I , you will assure new or modified products conform to requirements and establish compliance with the quality system. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. You will support new...

Quality Engineer This position works out of our Barceloneta location in the Abbott Vascular division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. This is an exempt role First shift (Monday to Friday) . As the Quality Engineer, you’ll Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. What You’ll Do Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Identifies manufacturing process defects (scrap, nonconforming material, customer complaints), dispositions non-conforming...

Senior Manager, Quality Engineering - Minnetonka MN This position works out of our Minnetonka , MN location in the Electrophysiology business. 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 Senior Manager Quality Engineering , you’ll provide leadership and guidance for the quality engineering department supporting commercial products and new product development. This role is responsible for developing goals, objectives, procedures, policies, and systems that are in line with company goals and objectives, mission and...

Are you looking for a patient-oriented, innovation-driven role that inspires you and promotes your career? Then take your future in your hands and become part of our team as a Associate Director Clinical Program Quality This role combines global strategic influence with meaningful impact on patient safety, data integrity, and the successful delivery of complex clinical programs across multiple therapeutic areas. It offers you a unique opportunity to lead high-visibility inspections, shape risk-based quality strategy, solve complex challenges, and act as a trusted advisor to senior stakeholders while driving continuous improvement across the organization. How you will contribute Provide quality...

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

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

PRINCIPAL OBJECTIVE OF THE POSITION The Senior Specialist, Validation Engineer II supports the successful implementation of manufacturing, and laboratory equipment alongside facilities and utilities at multi-use sites through interaction with internal customers and external service providers. The incumbent is tasked with qualifying new equipment, facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of low to moderate complexity. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve...

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

Job Title Associate Quality Engineer This position works out of our Arecibo location in the CRM division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. As the Associate Quality Engineer, you will provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. The Associate Quality Engineer will work with line supervisor, manufacturing engineer, and other team members, to address all opportunities...

OBJETIVES Ensure the physicochemical quality of pharmaceutical products through relevant quality controls. Ensure compliance with applicable national and international standards and regulations, as well as internal quality standards. Promote a culture of continuous improvement, identifying opportunities for optimization in the laboratory's processes and procedures. ACCOUNTABILITIES Perform physicochemical analysis of finished drug products. Control stock of reagents, solutions and titrated solutions. Knowledge and management of laboratory equipment HPLC, Karl Fischer, dissolutor test, UV spectrophotometer, coagulometer, SDS-Page, ELISA, etc. Prepare solutions and reagents from the Quality Control lab. Verify analytical related documentation. Support the Analytical Services team in the development and transfer...

About the role As a Quality Assurance Inspector II, you are responsible for inspection activities for all chemicals and components used in the manufacturing process. You will ensure raw materials meet specifications and reject those that fail to meet quality expectations. How you will contribute Perform sampling of chemicals in a classified room using appropriate gowning and safety measures. Perform routine cleaning of classified room used for chemical sampling. Conduct physical analysis on incoming chemicals as required per material’s specification. Responsible for the quarantine and/or destruction of nonconforming materials. Responsible for inspection and release of production materials, components, and chemicals...

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. Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through robust QA processes and systems. Our approach is agile,...

Key Responsibilities Serve as a Lead Quality Engineer for medical device combination product development programs, with a strong focus on design controls, risk management, and lifecycle quality oversight . Partner closely with Device Engineering on new combination product development, supporting design verification, design validation, and technology transfer activities. Ensure compliance with applicable regulatory requirements and standards , including FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971 , and Gilead Quality System requirements. Plan, implement, and track approved quality improvement initiatives , ensuring timely execution of action items and deliverables. Interface...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. The Associate Director / Auditor, a member of the Quality Compliance and Audits (QCA) group, is responsible for providing independent quality oversight...

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. This is an on-site role supporting the Global Operations & Supply Chain organization at the Boulder, CO manufacturing facility. As a Quality Engineer, you will serve as a key member of a cross-functional core team responsible for supporting the production of Class II medical...

The Medtronic Clinical and Regulatory Solutions (MCRS) organization is seeking a Senior Program Manager to serve as the execution enablement lead for regulatory real estate initiatives, including site exits, consolidations, and footprint optimization. This role supports global real estate strategy by partnering directly with regional and local Regulatory Affairs (RA) teams , who retain execution ownership. The role accelerates progress by improving data readiness, structure, coordination, and early issue resolution—ensuring site exits with regulatory impact move forward efficiently and predictably. This role will partner closely with regulatory affairs professionals across the globe, especially in Europe and Asia. The individual operates...

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. Responsibilities The QC Laboratory Technician (Lab Tech) is responsible for supporting...

Business Introduction Part of the GSK global network of 37 manufacturing sites that produce high-quality medicines and vaccines, GSK Marietta makes a positive impact on the health of millions of people every year. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We seek the very best minds and capability to help us deliver world-class performance with our current business and shape best...

Abbott Molecular Diagnostics is a leader in molecular diagnostics to deliver best-in-class innovative testing solutions for people around the world for answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics. We have an opportunity for the Technician Quality role based in the Des Plaines, IL location. Shift Monday to Friday 200 PM-1030 PM What You’ll Work On Support audits, regulatory inspections, and global quality compliance requirements. Perform Quality Control...

Abbott Molecular Diagnostics is a leader in molecular diagnostics to deliver best-in-class innovative testing solutions for people around the world for answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics. We have an opportunity for the Senior Technician Quality role based in the Des Plaines, IL location. Shift Monday to Friday 200 PM-1030 PM What You’ll Work On Support audits, regulatory inspections, and global quality compliance requirements. Perform Quality...

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...

The primary focus of the Specialist, Quality Control (QC) role will be to perform GMP testing to support product release and in-process testing. This role will also provide technical support and troubleshooting for analytical or microbiological tests. Perform or support cGMP activities, such as but not limited to, sample management, product testing, raw material release, environmental monitoring sample collection and processing, and system and equipment maintenance support. Support assay transfer and method validation. Identify and facilitate continuous improvement projects. Identify and initiate Deviations, CAPA’s and Laboratory Investigations. Perform data verification, data review and review of GMP documentation for general methods....

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,...

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...

Introduction to role Are you ready to set the global agenda for cyber governance and regulatory adherence within a firm where trusted, protected technology accelerates life-changing medicines to patients? Can you translate complexity into crucial action that protects trust while enabling ambitious innovation and speed? As Executive Director for Global Cyber GRC, you will lead the enterprise approach to information security. You will coordinate technological risk and ensure our most critical data, platforms, and partners operate with resilience, regulatory confidence, and clear accountability. You will connect cyber risk to strategic decisions, equipping the company’s leadership team and Board with sharp,...

Software Quality Director Careers that Change Lives Transforming Patient Management with Smart Technology! The Software Quality Director will lead our software quality organization within CRDN supporting both current products in the markets, ensuring ongoing reliability, performance and customer satisfaction as well as new product development and release initiatives. This role is accountable for managing and developing a high-performing quality Engineering team, defining the long-term quality strategy, and ensuring the delivery of reliable, high-quality software across our product portfolio. The Software Quality Director will balance strategic vision with operational excellence- driving quality initiatives across the organization while overseeing day-to-day...

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

The QA Analyst position supports the activities and initiatives of the Quality Manager to implement and manage the Quality System. This includes support on policy &procedure, program management, patient record review, internal/external audit, and metrics and trend analysis and reporting. Responsibilities Responsible for implementing and maintaining the effectiveness of the quality system. Provides effective quality controls to the referral management, call center and fulfillment operations. Monitors compliance with all AbbVie and Pharmacy Solutions policies and procedures in addition to all federal/state/local governmental and pharmacy laws and regulations. Develops QA training programs and materials and provides training to departmental personnel. Evaluates,...

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 Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and AbbVie policy compliance for the manufacturing plant. Responsibilities Assist Validation Engineer in the validation and certification of all new process equipment and periodically review all certified systems to assure the capability of meeting quality requirements. Responsible for implementing and maintaining the effectiveness of the Quality...

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. Associate Director - Global Patient Safety About Lilly At Lilly,...

SENIOR REGULATORY AFFAIRS SPECIALIST Onsite Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare FDA, European, and Canadian submissions for product changes to ensure timely approval for market release. Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed. Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product...

We are searching for the best talent for Sr. Validation Engineer. 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 Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more...

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 About Oncology 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. Our Oncology team is focused...

The Manager, 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 complex investigations/ CAPAs / effectiveness checks associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems. Author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program....

This position will develop comprehensive internal and vendor quality oversight strategies for In Vitro Diagnostics (IVD), Companion Diagnostics (CDx), and Digital health assets within a regulated environment. The Director will serve as a key collaborator across external partners, internal R&D, Regulatory, Clinical, IT/Digital, and Quality organizations, ensuring fit-for-purpose, risk-based quality oversight aligned with a rapidly evolving global diagnostic and digital health regulatory landscape. This role is accountable for the development, implementation, and continuous improvement of QMS processes and oversight, including global audit strategy, vendor quality oversight, inspection readiness, and regulatory intelligence for IVD, CDx and Digital health programs. This position...

Join Early Oncology’s Translational Medicine (TM) Global Operations team to drive on quality across our Translational Medicine and Biomarker Science & Technology (BST) organizations, including Labs, Biomarker Operations, and Translational Strategy. As a key quality partner , y ou will advise on compliance and risk, lead continuous improvement, and champion a culture of quality excellence that delivers high-quality science to patients . Key Responsibilities Review, assess, and communicate the status of the Quality Management System (QMS) for TM and BST teams, partnering with stakeholders and business process owners to recommend continuous improvements aligned to AZ Global Standards, ICH GCP and...

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

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety...

Quality Compliance Senior Manager, GMP/GDP Inspections Global Process Owner (GPO) What you will do As part of the GxP Quality Management System (QMS) architecture, the GMP/GDP Inspections Global Process Owner (GPO) leads the design, governance, and continuous advancement of the end‑to‑end GMP/GDP inspection lifecycle , from inspection readiness and preparation through inspection execution, outcome management, and regulatory commitment tracking. This role is a critical leader within the Inspection Lifecycle Management organization , ensuring consistent, compliant, and inspection‑ready practices across the global network for Health Authority, Notified Body and Business Partner inspections of Amgen. This role is accountable for establishing...

Quality Technician - Microbiology This position works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. As the Quality Technician - Microbiology , you’ll undertake the role of as Technician Quality with minimal supervision. Execution of daily activities with minimal supervision. Perform microbiology...

Quality Engineer This position works out of our Barceloneta location in the Abbott Vascular division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. This is an exempt role First shift (Monday to Friday) . As the Quality Engineer, you’ll Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. What You’ll Do Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Identifies manufacturing process defects (scrap, nonconforming material, customer complaints), dispositions non-conforming...

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....

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 Senior Manager of Quality System will report to the Director of Operations, Quality and Compliance within the Strategic Operations function of AbbVie Patient Services. This role is responsible for supporting the established Quality Management System, including Training, Document Management Systems, Quality Processes utilized across our patient support programs. In addition, this role will have BSO responsibilities of the Quality & Compliance Platform (GxP) housed by approved third party to ensure innovation, advancement of capabilities, reporting needs and alignment with functional program owners while ensuring SLC and Data Protection and Privacy enforcement. Responsibilities Be a champion of establishing the environment...

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. Lilly is looking for experienced quality assurance associates to support our...

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 Sr. Principal Associate QA Authorized Quality Representative - AQR is...

We're seeking a driven and talented Validation Engineer to support manufacturing operations through close collaboration with cross‑functional partners. This role is critical in defining, implementing, and maintaining validation activities that ensure robust, compliant manufacturing processes and systems. The ideal candidate brings experience in quality engineering, process development, or process engineering, and can quickly develop while working independently within a fast‑paced, team‑oriented environment. As a Validation Engineer, you will play a key role in driving overall quality performance and compliance by leading validation deliverables and activities across manufacturing systems and processes. Responsibilities Represent the Consumable Validation group as the validation subject...

The Director, Clinical Quality & Development Operations (CQDO) Inspection Excellence is a key contributor in Global Clinical Operations (GCO’s) audit and inspection management program, focusing on GCP health authority inspection planning, logistics, pre and post inspection support, ensuring all activities are conducted in compliance with health authority regulations (e.g. FDA, EMA, etc.). In addition, the Director will also contribute to regulatory intelligence activities, partner with local R&D functions and study teams to create a quality culture within Vertex and help reach a sustained state of inspection readiness. Key Duties and Responsibilities Lead inspection readiness and inspection preparation activities for GCO,...

At Medtronic, quality is at the heart of everything we do—it’s how we fulfill our Mission to alleviate pain, restore health, and extend life. As a Quality Engineer II at our Nathan Lane Manufacturing site, you will be at the forefront of driving excellence in our products and processes. You’ll leverage your experience to ensure our life-changing therapies meet the highest standards of quality, compliance, and reliability. This role requires you to be onsite Monday through Friday, providing you the opportunity to collaborate closely with cross-functional teams in a fast-paced, hands-on environment. If you’re ready to take on a meaningful...

Our Vascular business develops innovative, minimally invasive, and cost-effective products for the treatment of coronary and peripheral vascular disease. Quality Engineer I is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What You’ll Work On Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements Assist in the implementation of assurances,...

This role is critical to turning strategy into action, helping drive business goals, regulatory compliance, and continuous improvement. We’re looking for a motivated, detail-oriented professional to join our team and lead the preparation and approval of key quality documents, including Annual/Periodic Quality Reviews, Quality Agreements, and technical reports and memos. In this role, you will serve as the site lead for center of excellence teams and partner cross-functionally with Quality Control, Product Quality Assurance, PDST, Validation, and Compliance to drive document alignment and approvals. You will also work directly with third-party clients, suppliers, and other network sites to ensure timely...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

Employer Biosense Webster, Inc. Staff Quality Engineer - Quality LCM Job Code A011.5768 Job Location Irvine, CA Job Type Full-Time Rate of Pay $125,000 - $150,000 Job Duties Plan and coordinate quality assurance projects and activities throughout lifecycle of BWI's products, primarily electrophysiology catheters, cables, and systems. Serve as subject matter expert on Quality LCM (Life Cycle Management) matters. Use Quality Engineering tools/processes in the development and implementation of practices for effective and efficient development, transfer, and maintenance of products, including manufacturing transfers, project management, shelf life evaluations, and compliance. Collaborate with QE-NPD, R&D, PMNPD, Operations/Supply Chain, BWI-Israel and...

Analyst, Quality Control (P-23_E4) Entry to developing individual contributor, who works under close supervision. Assists staff in various processes in the Quality Control function. Supports day-to-day laboratory activities such as sample management, supply ordering and receipt, and general housekeeping. Assists with analysis, qualification/validation activities, and lab investigations. Supports data review and metrics reporting. Executes continuous improvement projects with supervision. May execute testing under supervision. Assists laboratory staff with sample receipt, management of reagents and supplies, and general housekeeping. Tests samples of finished goods under general supervision. Applies developing knowledge of Quality Control standards to review results of quality analysis...

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

This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Supplier Quality Enginee r II drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You’ll Work On Assess potential new suppliers for technical, quality and...

The Quality Assurance Engineer II position works 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 position is responsible for activities related to design control; qualification; specification and corrective and preventative action of medical devices, including software as a medica device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. Lead/support design planning efforts to include heading CFTs; establishing deliverables and tracking completion...

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...

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

Director, Global Regulatory Lead – Obesity & Related Conditions What you will do The Director, Global Regulatory Lead (GRL) provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions—a rapidly evolving therapeutic area requiring sophisticated scientific, clinical, and regulatory assessment. The GRL is accountable for developing and executing global regulatory strategies, shaping cross-functional decision-making, and leading global interactions with Health Authorities and external partners. This role ensures regulatory strategies fully reflect the unique scientific, mechanistic, and clinical complexities of metabolic disorders. Key Responsibilities Regulatory Strategy & Scientific Leadership Develop and lead global regulatory strategy for obesity...

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

Director, Global Regulatory Lead – Obesity & Related Conditions (Chronic Weight) What you will do The Director, Global Regulatory Lead (GRL) provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions—a rapidly evolving therapeutic area requiring sophisticated scientific, clinical, and regulatory assessment. The GRL is accountable for developing and executing global regulatory strategies, shaping cross-functional decision-making, and leading global interactions with Health Authorities and external partners. This role ensures regulatory strategies fully reflect the unique scientific, mechanistic, and clinical complexities of metabolic disorders. Key Responsibilities Regulatory Strategy & Scientific Leadership Develop and lead global regulatory strategy...

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 have an exciting opportunity within US Medical Affairs for a Senior Manager in our Patient Access and Quality of Care (PAQ)...

About the Role This application is for a 6-month student role from July - December 2026. Resume review begins in January 2026. The Global Trade Compliance team’s mission is to enable Biogen’s purpose and commitment to patients, shareholders and communities by managing risks, creating values, driving excellence in execution and critical capabilities. We do this by ensuring that all our products (finished drugs, drug substances, clinical samples, etc.) move across multiple countries in compliance with international trade regulations and without delays. Global Trade Compliance also pays a key role across Biogen’s end to end business planning by completing due diligence...

Your skills could be critical in helping our teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU, and/or global regulatory strategy for assigned projects, including Health Authority (HA) interactions. The RS provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives....

OBJECTIVES/PURPOSE Advance strategic quality leadership by embedding global standards across Clinical, Pharmacovigilance, and Medical Quality (CPMQ), ensuring regulatory alignment and operational excellence. Drive innovation and transformation through organizational planning, digitalization, and capability building—enhancing systems, analytics, and process efficiency across CPMQ and R&D. Strengthen quality oversight and risk management, leading compliance strategies, monitoring systems, and continuous improvement initiatives that mitigate systemic risks and foster resilience. Serve as a strategic partner and change agent, shaping clinical trial delivery transformations, guiding GCP strategy, and aligning quality initiatives with enterprise priorities and a culture of learning. ACCOUNTABILITIES Identify and lead innovative transformation initiatives across...

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...

Sarepta is searching for an experienced professional to lead and support critical activities related to Sarepta’s Regulatory Information Management System (RIMS), which is used to develop regulatory submissions for dispatch to health authorities globally. The Senior Manager, RIM will have responsibility for assuring that RIMS is used in an effective manner across the organization in adherence to applicable internal procedures and guidelines, that users have the knowledge, skills, and training to use RIMS effectively for their needs, and that RIMS is monitored from a data perspective. The Opportunity to Make a Difference Engage with stakeholders to define and improve internal...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As an Associate Director, CMC Regulatory Affairs for Biologics, at Gilead you will be responsible for defining regulatory strategy for one or...

About the role The Head of Regulatory Legal is responsible for developing and leading the global legal strategy supporting Global Quality (GSQ), Research & Development (R&D), Regulatory Affairs, and Plasma Derived Therapies (PDT) across the enterprise. This role provides high-level legal counsel on regulatory matters (FDA, EMA, and other global agencies), manufacturing, supply chain, and the product development lifecycle from research through clinical trials. As a trusted advisor to senior leadership, the Head of Regulatory Legal leads a team of legal professionals, ensures compliance with all relevant laws and regulations, mitigates legal and regulatory risks, and collaborates across business units....

Under general supervision, participate in new and sustaining product/process teams to support design verification tests, process validations, quality processes. Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards. As needed, assists to develop quality-engineered systems and products, and support qualification and validation activities. Will work on complex problems and projects. Will show leadership by innovating compliant approaches and solutions to problems. Will receive technical guidance on sophisticated problems, but independently develops...

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control Analytics - CAR-T in Raritan, NJ! This shift is going to be scheduled 400pm - 200am through Sunday - Wednesday. 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...

The Associate Director of Regulatory Strategic Writing (RSW) is responsible for providing leadership and direction for clinical and regulatory writing projects for one large or multiple compounds within a therapeutic area within budget, with quality, and in accordance with timelines. Responsibilities Directly leads multiple individual contributors located in geographically disbursed locations with oversight of both internal and external staff. Assists in the selection of freelance consultants or other vendors. Participates in continual improvement across Strategic Medical Writing best practices, processes, and performance. Leads execution of cross-functional initiatives. Effectively utilizes project management tools/techniques to drive multiple projects; responsible for overall project...

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. Open to our Newton, MA or Mounds View, MN offices. Join Medtronic as a Software Reliability Engineering Program Manager - Quality Core Team Member and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll...

Position Overview The VP Global Patient Safety & Global Safety Therapeutic Area Head - Oncology will be responsible and accountable for the definition and execution of the worldwide pharmacovigilance strategy for all investigational and marketed products in their Gilead Therapeutic Area. The VP will lead broadly in a cross-functional and multi-cultural environment and leverage extensive scientific and pharmacovigilance experience to represent Global Patient Safety in discussions with senior leadership, Executive Management and regulatory authorities and lead benefit/risk efforts for the specific therapeutic area across the company. Key Responsibilities Strategic Thinking Set the overall safety strategy for a specific therapeutic area...

Essential functions include, but are not limited to Requires knowledge and experience in the Quality Control discipline and solves a range of straightforward problems. Analyzes possible solutions using standard procedures. Builds knowledge of the company, processes, testing and customers. Receives a moderate level of guidance and direction and also proactively seeks advice/information from others when addressing serious business issues that may impact other functions. Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group while contributing and adding value to the achievement of team goals. Demonstrates a deep understanding of customer needs, requirements, and expectations. Continuously...

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director of Quality Control, CAR-T Manufacturing! This position will be located in Raritan, NJ. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone...

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 Director, Global Regulatory Leader. This position is a hybrid role and can be located in Spring House, PA; Titusville, NJ; or Raritan, NJ. Remote work options may be considered...

Johnson & Johnson is hiring for a Sr. Quality Engineer, Design Assurance – Shockwave (Reducer) to join our team 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, Vision Jacksonville, FL is recruiting for a Senior Software Validation Quality Engineer, Quality Operations, location in Jacksonville, FL. The Senior Software Quality Engineer is primarily responsible to manage the development & implementation of software validation policies and procedures. They will manage and conduct software validation projects in support of existing computerized systems in the Jacksonville campus. Project responsibilities will be focused on medium to large validation projects. This position may also oversee software qualification activities related to contract repackaging and contract manufacturing projects. Key Responsibilities Facilitates and leads software validation activities/projects with specific focus to manufacturing systems....

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 Lilly is currently constructing an advanced manufacturing facility for...

This Regulatory Affairs Specialist will work out of our Alameda, CA location in the Diabetes Care Division. As an individual contributor in the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department to ensure efficient and compliant business processes and environment are followed. With limited supervision you will execute tasks and partner across business functions. The individual will be reviewing Labeling, Advertising and Promotional materials, determining risk, identifying data needed, obtaining data, and ensuring that the information is reliable and effectively presented to substantiate claims. You may also have opportunities to participate in...

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

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Quality Assurance Specialist What you will do In this vital role you will serve as Quality Assurance...

As the Executive Director, Strategy & Program Excellence for the Compliance & Ethics (C&E) department, you will report directly to the SVP, Chief Compliance & Ethics Officer (CCEO) at Bristol Myers Squibb. You will serve as a senior strategic advisor and program leader, driving the ongoing assessment, innovation, and continual enhancement of BMS's healthcare compliance program. You will be a member of the Compliance & Ethics Leadership Team (CELT), partnering closely with all verticals of the C&E organization — both locally and globally — as well as key enterprise stakeholders across Legal, Finance, Internal Audit, Corporate Communications, and beyond. The...

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

Head of Clinical, Regulatory, Quality & Therapeutic Area Unit (TAU) Data, Digital & Technology (DDT) Location Cambridge, MA (Hybrid) Level Vice President I Job code DD_TGM_J_DDA_P Reports to Head, R&D and Global Medical Data, Digital & Technology (DD&T) Role on Leadership Team Member, R&D and Global Medical DD&T LT Role Overview Takeda is recruiting an accomplished executive to serve as Vice President and Head of Clinical, Regulatory, Quality & Therapeutic Area Unit (TAU) Data, Digital & Technology (DDT). This strategic leadership position requires partnering closely with Clinical Development, Regulatory Affairs, R&D Quality and Therapeutic Area Units to advance business-facing technology...

Expected Areas of Competence Develop and lead Global and US Regulatory activities for a Development Team (s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement. Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans Provide leadership to resolve critical regulatory project issues, bring the appropriate regulatory experts together as needed Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders Develop registration strategy for a product, and translate that into operational...

The Senior Director, Global Logistics, Warehousing and Trade Compliance is responsible for defining and executing the global strategy, operational leadership, and compliant storage and movement of materials supporting R&D, Clinical, and Commercial programs across Beam. This role provides end‑to‑end leadership across global logistics operations, warehousing networks, and trade compliance, ensuring reliable supply, regulatory adherence, and scalable infrastructure to support pipeline growth and commercialization. This position reports to the Vice President, Supply Chain and serves as a key member of the Supply Chain Leadership team, partnering closely with Technical Operations, Quality, R&D, Finance, Legal, Procurement, Clinical Patient Supply and Commercial Patient...

Staff Quality Engineer for TRB & Change Control SME for JJV. Primary Focus Position Overview This role combines Technical Review Board leadership with Global Change Control governance in Johnson and Johnson Vision (JJV &JJSV). The position is responsible for leading TRB discussions, ensuring compliant and efficient change management, and driving continuous improvement across quality systems. Exceptional communication skills, the ability to facilitate challenging conversations, and a strong leadership presence are required for this role. In-depth knowledge of medical device Quality Management Systems (QMS), Risk Management, and Change Management processes is expected, along with the confidence to challenge assumptions and guide...

About Cardiovascular 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 Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for...

Join Medtronic as a Sr. Engineering Program Manager - Quality Core Team Member and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to support design and development of cardiac surgery products. By blending technical expertise with a passion for quality, compliance, and improving patient outcomes, you'll have the opportunity to impact global healthcare. Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to...

About BioLife Plasma Services BioLife Plasma Services, a subsidiary of Takeda Pharmaceutical Company Limited, is an industry leader in the collection of high-quality plasma, which is processed into life-saving plasma-based therapies. Some diseases can only be treated with medicines made with plasma. Since plasma can’t be made synthetically, many people rely on plasma donors to live healthier, happier lives. BioLife operates 250+ state-of-the-art plasma donation centers across the United States. Our employees are dedicated to enhancing patients' quality of life and ensuring that the donation process is safe, straightforward, and rewarding for donors who wish to make a positive impact....

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

Regulatory Affairs Manager Our location in Lake County/Abbott Park, IL, currently has an opportunity for a Regulatory Affairs Manager . WHAT YOU’LL DO The Latin America Manager of the Regulatory Affairs Innovation oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports for pediatric nutritional products distributed in Latin America. Interacts with Affiliate Regulatory, Division Regulatory, international manufacturing plants, and other Divisional functional areas. Serves as regulatory liaison throughout product lifecycle. Participates in some of the following Innovation product plan development and implementation, regulatory submission strategy, risk management....

This position works out of our Alameda, CA location in the Diabetes Care division where 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. As the Quality Engineer II you will be responsible for activities related to design control; qualification; specification and corrective and preventative action of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. You will lead/support design planning efforts to include heading CFTs; establishing...

Ready to redefine what's possible in molecular diagnostics? Join a team of brilliant, passionate innovators determined to transform healthcare. At BillionToOne, we've built a category-defining, publicly traded company on Nasdaq where transparency fuels trust, collaboration drives breakthroughs, and every contribution moves the needle on our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we build products that are 10x better than anything that exists today. With over 700 employees, half a million patients helped, and one of the most successful IPOs in medical diagnostics history behind us, we're just getting started. Our scientists,...

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. This position works out of our Westford, MA location in the AVD Vascular division. Supplier Quality Engineer is r esponsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers. Must be able to handle supplier audit situations and interactions in a tactful, professional and effective manner. What You’ll Work On Supplier Audits Develop and execute to a supplier audit schedule per current requirements. Develop audit plans and associated supplier communications. Approve and monitor Supplier CAPA plans and activities to closure...

The Cardiovascular portfolio delivers innovative therapies and technologies to diagnose, treat, and manage cardiovascular disease. It spans solutions for coronary and peripheral artery disease, structural heart and aortic conditions, cardiac rhythm management, and hemodynamic monitoring. The portfolio focuses on improving clinical outcomes, enabling less invasive care, and supporting physicians and health systems with integrated, evidence‑based solutions that enhance patient care and procedural efficiency. 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...

Are you ready to shape how we communicate life-changing science to patients and healthcare professionals—safely, compliantly, and with impact? This role leads the US advertising and promotional compliance strategy for assigned products, ensuring our external communications are scientifically rigorous, fair-balanced, and fully aligned with FDA requirements. You will partner closely with cross-functional colleagues in medical, legal, regulatory, commercial, and regulatory operations to drive high-quality promotional and scientific materials from concept to submission. Can you anticipate regulatory risk and translate complex guidance into clear, actionable direction for teams? Your work will enable timely launches, confident market presence, and consistent, ethical engagement...

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...

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 The Quality engineer facilitates and enforces compliance with Good...

(This position is part of our Corporate Legal Compliance team). Plays a key role in strengthening and enhancing the Company’s compliance monitoring and analytics capabilities by leading data-driven monitoring initiatives and translating risk into practical, measurable monitoring processes and reporting mechanisms. _ Your Contributions (include, but are not limited to) Independently scope, design, and implement data-driven compliance monitoring initiatives in alignment with Compliance leadership priorities. Translate compliance requirements into measurable monitoring frameworks, dashboards, and key risk indicators (KRIs). Develop, maintain, and enhance compliance dashboards and reports to support leadership oversight. Identify opportunities to strengthen monitoring and analytical processes. Conduct risk-based...

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...

About the role As a Quality Associate II at the Takeda Round Lake aseptic pharmaceutical manufacturing facility, you will work to perform review and approval of released raw material documentation. You will focus on product quality and compliance through Documentation review (Batch records, electronic batch records, etc.), Investigation/Change control approvals and Quality oversight of manufacturing processes. How you will contribute Responsible for raw material and bulk container receipts, release, and investigation if any issues are found. Follow-up with appropriate Takeda facilities for documentation correction in timely manner. Manufacturing support activities including batch record documentation, issuance of Batch record, approval of...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will p rovide strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative, robust, fit-for-phase regulatory strategies for small molecule and biologic products for FIH to pre-pivotal development, maximizing global regulatory success and minimizing time to...

This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This position is responsible for activities related to design control, qualification, specification, and corrective and preventive action (CAPA) of medical devices, including software as a medical device (SaMD), digital platforms, and globally deployed web‑based systems supporting regulated products. The role will have a particular emphasis on governance, design control,...

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. MAIN PURPOSE OF ROLE We are seeking a high caliber Software Quality Engineer supporting the design and development of company products ( mainly mobile apps) , software reliability , developing and maintaining processes and...