Quality & Regulatory Jobs in Pharma & Biotech

The Director, Regulatory Affairs Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for products in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Continuously expands TA knowledge in obesity and ensures strategic messaging and content of global regulatory dossiers. Proactively anticipates and mitigates regulatory risks. Ensures compliance with Global regulatory requirements. Manages compounds in the obesity TA through all phases of development, including post approval and through the...

Leads the Branchburg Quality Control Laboratories and serves as integral member of the Quality leadership team. The role is accountable for ensuring compliance with all applicable regulatory and compliance requirements and must ensure the site is anticipating and building capabilities in-line with regulatory expectations and trends. Provides strategic, scientific, and operational leadership for all QC testing activities supporting the commercial manufacturing of tissue products. This role oversees laboratory functions, personnel and budget management, method validation and transfer, regulatory compliance, and continuous improvement initiatives. The Senior Manager will partner cross-functionally to maintain reliable product quality and throughput. Responsibilities Lead a team...

Responsible for managing and implementing quality compliance programs and measures to ensure AbbVie medicines and ingredients are safe, effective, and of appropriate quality. Initiates and leads high impact, global, cross-functional projects as response to complex large scale external compliance standard updates and changes. Benchmarks and participates in industry interest organizations, representing AbbVie’s interests, and influences regulation modification and establishment when possible. Responsibilities Owns external compliance standard updates, from identification of the change through assessment and implementation for assigned scope Manages the assessment and implementation of compliance related changes according to official timelines, acting as the event owner in the corporate...

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

The Director, Regulatory Affairs Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for products in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Continuously expands TA knowledge in obesity and ensures strategic messaging and content of global regulatory dossiers. Proactively anticipates and mitigates regulatory risks. Ensures compliance with Global regulatory requirements. Manages compounds in the obesity TA through all phases of development, including post approval and through the...

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. Find...

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...

Position Overview - Basic Functions & Responsibility Essential functions include, but are not limited to Operational shift team lead, responsible for daily emergency response, safety, and security functions. Provides site-wide fire protection, emergency medical, and hazardous materials response coordination. Conducts scheduled and random inspections of all production, business, and operational support areas for fire, life safety, and security concerns. Daily functions include responsibilities for loss prevention, security, emergency response, project support, facilities, maintenance, and other service areas. Conducts fire and security audits, surveys to test existing controls, and evaluates risks involving protection of tangible and intangible company property. Enforces company...

Job Summary The Asset Quality Lead, GCP Inspections (AQL) is responsible for driving GCP Quality by maintaining ‘quality’ line-of sight for assigned clinical trial programs/protocols. With this focus, the AQL role brings deep knowledge of GCP quality and risk management principles to asset and study teams. In partnership with the cross functional study team and functional lines in Clinical Development & Operations, the AQL will ensure program and study level quality oversight, drive quality risk management and inspection readiness activities and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS. The...

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 Senior Director/Executive Director, Global Regulatory Affairs,...

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...

The Serialization Senior Manager contributes to the design, implementation and maintenance of global serialization / track and trace at Vertex. The Serialization Senior Manager acts as a primary serialization contact on new product launch working teams, creates and maintains serialization SOPs and troubleshoots serialization related operational issues to ensure no disruption to commercial supply. The Serialization Senior Manager independently manages multiple projects or phase(s) of a larger project related to serialization and master data management and builds relationships with internal and external stakeholders to ensure seamless product launch and uninterrupted commercial supply. Key Duties and Responsibilities Oversee alert management processes...

We are seeking a highly skilled and experienced Compliance Associate Director to support in leading and executing compliance audits and monitoring across our organization. The ideal candidate will ensure adherence to regulatory requirements, internal policies, and industry standards while identifying areas for improvement and mitigating risks. This role requires a strategic thinker with strong leadership skills, exceptional attention to detail, and the ability to collaborate across departments to maintain a culture of compliance and integrity. The Compliance Associate Director will support the OBIE Assurance program, interacting with business colleagues across all regional Commercial, Medical, Clinical, Research, Development, and support functions....

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Sr. Manager, Quality, Development Packaging at Gilead you will provide quality review and ensure compliant execution of packaging development activities....

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 with internal cross‑functional teams,...

2026 Summer Intern - Research and Early Clinical Development(ECD) Quality, Compliance & Clinical Capabilities (QC3) Department Summary The Quality, Compliance & Clinical Capabilities (QC3) group is the backbone of quality oversight and management in Genentech Research & Early Development’s (gRED) Early Clinical Development (ECD). Our mission is to be a trusted strategic partner to gRED. We enable a proactive compliance approach, ensuring successful delivery of quality and compliance programs enterprise-wide. We engage, educate, and empower gRED teams to effectively execute risk-based quality and compliance solutions. This internship position is located in South San Francisco, on-site. The Opportunity As an intern...

If you have experience in regulatory compliance and enjoy working with cutting-edge medical technologies, we’d love to hear from you. Join us as a Senior Regulatory Affairs Specialist. Our products include different technologies (active and non-active, hardware and software) and are sold in more than 30 countries. The Senior Regulatory Affairs Specialist will be part of the US Regulatory team, reporting to Regulatory Affairs Manager, supporting a wide range of activities with frequent interactions with corporate teams in US and globally. Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document...

Sr Supplier Quality Engineer Cranial & Spinal Technologies Onsite We are seeking a committed professional to join our team. This position is onsite in Fort Worth, TX to support collaboration with local teams and global suppliers. We value what makes you unique. Together, we can change healthcare worldwide. In this exciting role as a Senior Supplier Quality Engineer, you will have responsibility for supplier quality activities for the CST O perating Unit (O U ) . The Supplier Quality team primarily supports NPI (New Product Introduction) projects and supplier management activities and processes for the OU. Cranial and Spinal...

Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. In this dynamic role as a Senior Quality System Specialist, you will play a key role in overseeing the development, implementation, and maintenance of quality systems, programs, processes, and procedures that ensure compliance with company policies and regulatory standards. You will work both independently and collaboratively across teams and functions to uphold the highest standards of...

Location Durham, NC 3 Days in office/week The role is responsible for supporting quality partnering across BioPharmaceuticals R&D, providing data-driven insights to inspection readiness, regulatory compliance, and empowering study teams to deliver clinical studies. The Associate Director, Clinical Quality is responsible for facilitating the delivery of Quality Management activities related to Clinical Operations within R&D working with partners across the business to embed quality/compliant practices while leading and guiding proactive inspection readiness activities. They are also accountable for identifying and sharing industry trends in quality for the new business area(s), in their scope, through benchmarking with industry peers, and collectively...

Job Title Quality Manager Our location in Temecula, CA, currently has an opportunity for a Quality Manager (Development) in our Vascular Division. This is an onsite role. This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. 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...

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. WORKING AT ABBOTT At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your...

This Regulatory Affairs Manager – International Compliance Operations will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This Regulatory Affairs Manager – International Compliance Operations will provide end to end support for the regulatory department to ensure efficient and compliant business processes and environment. This position has responsibility for compliance activities for products and processes. The individual may execute tasks and...

Component QA Engineer Develops, supports and approves acceptance criteria for materials and component qualification at the supplier including all applicable validation activities. Supporting improvement and corrective action in the quality of components sourced from outside suppliers. Provides quality input in the selection of suppliers. Provides technical and quality support to drive supplier corrective action, manufacturing yield issues and process improvements. Project focused, specifically on components for NPI, supplier resilience, GMI. Component QA Engineer role is integral to new supplier/component development. Supports component risk management processes with suppliers. What You'll Work On Support New Product Introduction (NPI) and components projects,...

Quality Assurance Manager As a Quality Assurance Manager for Complaint Investigations, they will be responsible for sustaining the complaint investigation operation, while developing a team and leading projects to advance the lab for future expectations with regards to compliance, capabilities, and workforce output. This role oversees engineers and leads for direct and indirect labor to sustain complaint investigations, and complaint returns. This role is responsible for establishing an operation that performs consistently to maintain requirements for investigation timeliness, and develop processes for new or updated products, while ensuring ongoing compliance and audit readiness per Abbott's Quality Policies and Global...

Job Title Quality Engineer Our location in Temecula, CA, currently has an opportunity for a Quality Engineer in our Vascular Division. This is a fully onsite role. The Quality Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. 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...

This position is on site at our Research Triangle Park, NC facility, and would include 20-30% travel, domestic and internationally About This Role The Senior Manager reports to the Global VTR Leader and is responsible for leading the VTR Biochemistry team at our biologics site, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products at internal/external sites and contract labs. The Senior Manager will prepare and review regulatory filings and respond to health agency requests (RtQs) using a risk-based approach. The senior manager...

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 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...

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

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity, and innovation. Abiomed is recruiting for an Entry‑Level Supplier Quality Engineer — Electronics to be located in Danvers, MA. About MedTech...

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....

We are searching for the best talent for a Design Quality Engineer II, Lifecycle to be based in Danvers, MA. Purpose This person will have the opportunity to perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products! Activities will include risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support statistical analysis and more! This role’s emphasis will be in support of Abiomed’s existing single-use heart pumps. You will be responsible for Support and lead Design Assurance engineering activities in support of Abiomed’s Life Cycle processes including design controls,...

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s). USA Req# R-062461 Switzerland Req# R-063952 Belguim/Netherland Req# R-063958 The Senior Director, Risk Management & Regulatory Intelligence has oversight for the Risk Management and Proactive Quality Planning functions for Innovative Medicine Quality & Compliance as well as the Regulatory Intelligence Programs across GxPs. This position is critical to the strategic design...

Regulatory Strategist - VIE Contract Location United States of America, Morristown Target start date 01/07/2026 iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28. PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship. PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure...

General/ The Senior Director, Manufacturing Technical Sciences QA is accountable for end-to-end technical quality oversight of cell and genetic program throughout clinical development, commercialization, product launch and post approval lifecycle management activities. This includes quality oversight of new process and product development, establishing relevant quality standards, ensuring internal and cross-functional alignment with industry and regulatory expectations, and identifying quality risks and mitigations throughout the life cycle for the assigned programs. The role will lead a team of process and analytical QA personnel and closely partner with operational stakeholders to participate in Cell & Genetic therapies projects, quality oversight of technical...

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

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

About GenerateBiomedicines GenerateBiomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform...

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...

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. The Senior Quality Control Laboratory Technician is responsible for performing advanced laboratory procedures independently for the testing of veterinary biologicals...

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...

Position Overview Maintains final retention of all manufacturing and packaging documentation and samples. Coordinates and prepares documentation for shipment of raw material and finished goods retention sample shipment to and from Wilson and other plant sites. Receives production samples for use in retention program, and enters sample information into Trackwise system Completes annual inspections of retained samples Tracks sample levels Coordinates the archival and retrieval of batch record documentation Primary Responsibilities Ability to perform routine assignments and develops competence by performing structured work assignments. Ability to use existing procedures to solve routine and standard problems. Requires knowledge and exposure 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. The Analytical Technology Solutions (ATS) team in De Soto, KS oversees the qualification and stability monitoring of reference standards for...

The Sr Director, Quality Systems and Compliance, is a full-time position located at the BMS Bothell Manufacturing Plant (JuMP) located in Bothell, Washington. The primary focus for this role is to lead the Quality Systems and Compliance teams to ensure site level Quality Systems (Deviation, CAPA, Change Control, Complaints, Data Integrity, Quality Risk Management, and Document Control) are appropriately designed, implemented, and measured for cGMP compliance and effectiveness. This position is also responsible for ensuring site compliance to health authority regulations and current good manufacturing practices ensuring site inspection readiness. The position leads the management of health authority (surveillance and...

The Associate Director, Audit Strategy and Vendor Quality supports the development and execution of risk-based audit strategies across Therapeutic Areas, R&D processes, and external vendors. This role focuses on operationalizing risk-based audit plans, delivering effective audit execution, supporting quality investigations and CAPA management, as well as proactively identifying and escalating quality risks. The Associate Director will lead and support maintaining and applying the vendor quality management framework such as vendor oversight plans, quality agreements, and governance metrics and supports inspection readiness and product submission activities through consistent, risk-based quality execution in partnership with RDQ Development Quality and business stakeholders. R&D...

The Associate Director, Audit Strategy and Vendor Quality supports the development and execution of risk-based audit strategies across Therapeutic Areas, R&D processes, and external vendors. This role focuses on operationalizing risk-based audit plans, delivering effective audit execution, supporting quality investigations and CAPA management, as well as proactively identifying and escalating quality risks. The Associate Director will lead and support maintaining and applying the vendor quality management framework such as vendor oversight plans, quality agreements, and governance metrics and supports inspection readiness and product submission activities through consistent, risk-based quality execution in partnership with RDQ Development Quality and business stakeholders. R&D...

The Associate Director, Audit Strategy and Vendor Quality supports the development and execution of risk-based audit strategies across Therapeutic Areas, R&D processes, and external vendors. This role focuses on operationalizing risk-based audit plans, delivering effective audit execution, supporting quality investigations and CAPA management, as well as proactively identifying and escalating quality risks. The Associate Director will lead and support maintaining and applying the vendor quality management framework such as vendor oversight plans, quality agreements, and governance metrics and supports inspection readiness and product submission activities through consistent, risk-based quality execution in partnership with RDQ Development Quality and business stakeholders. R&D...

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

The Director, GCP Audit Strategy and Vendor Quality is accountable for designing and executing a global, risk-based audit strategy to ensure compliance with Good Clinical Practice (GCP) requirements. This role will drive robust vendor quality oversight across all clinical trial service providers in close partnership with Development Quality. Key responsibilities include leading strategic planning for audits, managing vendor-related quality investigations, CAPA development, and ensuring timely resolution of quality issues. The Director will establish and maintain a comprehensive vendor quality management framework for CROs and other external partners. This includes oversight of vendor quality programs and collaboration with cross-functional teams within...

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 be responsible for supporting and maintaining quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency regulations. Uses problem solving, technical writing, and communication skills to gather cross functional buy in for improvements...

Personalized healthcare is the future. Bio-wearable technology will digitize, decentralize, and democratize healthcare, enabling consumers to take control of their own health. Diabetes is a growing problem worldwide, and at Abbott Diabetes Care (ADC) we are helping people with diabetes lead healthier, happier lives. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, and we‘re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels. ADC is responsible for the development and launch of new digital products based on the FreeStyle Libre platform, the world’s #1 continuous glucose monitoring (CGM)...

Supplier Quality Engineer I The Supplier Quality Engineer will support in the evaluation, selection, approval and maintenance of the division's approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities. What You'll Work On Ensures that the division’s approved supplier list is maintained and accurate. Assesses potential new suppliers and service providers for quality and quality system capabilities through the execution of on-site or desk top audits, and review of other objective evidence, as required. Communicates division’s approval requirements to supplier and monitors feedback per project timelines. Performs on-site quality...

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...

Senior Quality and Compliance Specialist This position works out of either our Abbott Park, IL or Irving, TX locations in the Transfusion Medicine business unit. 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 a Senior Quality Assurance Specialist , you’ll have the chance to support site compliance activities, including both external and internal audit management....

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...

The Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs (1) in emerging disease areas, (2) for additional development of registered Vertex medicines, and/or (3) for the support of Vertex marketed products. This incumbent will play a major role in shaping cohesive regulatory strategy across the assigned programs and ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy. This roles responsibilities may be global, regional or...

Quality Technician (Process Monitoring) III This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission Why We Exist Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. This position provides technical assistance to engineering to support manufacturing efforts by implementing corrective and preventative actions. Assists engineers in developing methods and procedures to control or improve manufacturing processes. What You’ll Work On Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Assists engineering in...

Job Title Compliance Manager This position works out of our Sylmar, CA location. This is an onsite role . Sets strategy for internal, clinical, and external audits (Regulatory Agencies, Corporate, Certification bodies, and major clients) ensuring sites are audit ready at all times. The incumbent manages a team of auditors across the sites and acts as a change leader, responsible for management of major global improvement activities to improve quality systems, audit readiness, and compliance. Represents the division within Abbott through Corporate based advocacy forums as well as external Regulatory Intelligence Forums such as the Notified Body Audit Coordination...

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

The Director, GCP Audit Strategy and Vendor Quality is accountable for designing and executing a global, risk-based audit strategy to ensure compliance with Good Clinical Practice (GCP) requirements. This role will drive robust vendor quality oversight across all clinical trial service providers in close partnership with Development Quality. Key responsibilities include leading strategic planning for audits, managing vendor-related quality investigations, CAPA development, and ensuring timely resolution of quality issues. The Director will establish and maintain a comprehensive vendor quality management framework for CROs and other external partners. This includes oversight of vendor quality programs and collaboration with cross-functional teams within...

The Medtronic Grand Rapids Manufacturing site is a key facility focused on the production of high-quality medical devices and components related to Cardiac and Vascular Group. Here, you can build a lifelong career rooted in exploration, innovation, and purpose—while helping advance healthcare access and equity for patients around the world. At our Grand Rapids site, you will lead nonconformance investigations, drive continuous operational improvements, collaborating with a highly engaged cross‑functional team at one of Medtronic’s most dynamic manufacturing locations. Together, we deliver life‑changing products that break down barriers to innovation and help create a more connected, compassionate world. As part...

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 Manufacturing Quality Assurance Specialist 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...

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 Analyst, Regulatory Policy and Intelligence (RPI) support the US RPI function by conducting research on regulatory intelligence questions and topics within assigned areas and regions. Responsibilities include analyzing and utilizing relevant regulatory approval databases, as well as preparing and delivering regulatory intelligence summaries both orally and in writing. The Analyst should be comfortable working in a dynamic environment and proactively contributing new ideas and process improvements that enhance assigned projects. The Analyst also serves as the office manager for the Rockville MD location and should be comfortable assisting with general office duties. This includes oversight of rental and service...

Position Principal Compliance Engineer, ECQ Location Summit West, NJ Purpose and Scope of Position The Principal Compliance Engineer, Equipment Commissioning & Qualification (ECQ), supports the successful operation of facility, laboratory, and business functions at Summit, NJ. This role involves interaction with internal team members, peer-level customers, and external service providers. The Principal Compliance Engineer will lead a team of contract or full-time personnel responsible for performing periodic reviews of equipment, policies, and procedures to ensure they remain in a validated state. Responsibilities include performing gap analyses, and leading small and large-scale projects to achieve departmental objectives. Required Competencies Knowledge,...

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. 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...

The Sr Quality Engineer role is essential to maintaining compliance with internal quality system requirements and supporting manufacturing operations. This position is responsible for critical activities including Developing and maintaining quality standards and protocols Performing statistical analyses to assess product and process compliance Supporting investigations, nonconformance resolution, and risk assessments Collaborating with Engineering and Manufacturing to ensure control over product quality Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality...

Location Louisville, Colorado and Parker, Colorado (will alternate between sites throughout the week) Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working 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 Supplier Quality organization at the Louisville, CO and Parker, CO manufacturing facilities. As a Sr. Supplier Quality Engineer, you will serve as...

The Quality Software Engineer II is an established individual contributor responsible for ensuring software systems meet rigorous quality standards throughout the development lifecycle. This role involves defining, implementing, and maintaining quality processes, conducting evaluations, and supporting verification and validation activities to ensure compliance with project, process, and contractual requirements. A strong background in robotics and experience analyzing software logs for quality and reliability are highly valued. Responsibilities Perform detailed software log reviews to identify anomalies, ensure compliance, and improve system reliability. Collaborate with cross-functional teams, including robotics engineers, to achieve quality objectives and project milestones. Develop, modify, apply, and maintain...

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

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U. S. without Abbott sponsorship. Independently contribute to Quality System processes...

The Principal Regulatory Affairs Specialist will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors has revolutionized the way roughly 6 million people worldwide manage their diabetes. This is an exciting opportunity with responsibilities for US submissions for new product introductions, which include breakthrough advancement in diabetes management and digital health technology solutions to address...

This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout division. What You’ll Work On Develop and conduct training of company personnel for the divisional software development and validation program. Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes. Create and execute or direct software validation protocols traceable to system/software requirements. Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems. Assist in the completion and maintenance of risk analysis, focused on software related risks....

We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Specialist, Quality Assurance will manage purchasing controls and supplier quality activities related to commodities and consumables used within the manufacturing of Core Dx final material. The role conducts supplier evaluations, approval of design changes/verifications, specifications and material qualifications. This individual will sit at our Lake Forest, IL office. What You’ll Work On Contributes to defining and timely achievement...

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...

Gilead Sciences is seeking a highly motivated and experienced Sr. Quality Assurance Specialist to join the Corporate Engineering and Facilities (CEF) team in Foster City, CA. This role is responsible for providing quality oversight and hands-on ownership, authoring, and execution for GxP quality records associated with CEF activities including facilities, utilities, equipment, instruments, and engineering systems. The Sr. Quality Assurance Specialist is responsible for ensuring compliance with applicable quality objectives, regulatory requirements, and current Good Manufacturing Practices (cGMP), and serves as the primary owner for applicable deviation investigations, corrective and preventive actions (CAPAs), effectiveness checks, and related change controls. This...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Global Support Function Division can provide you with great development and a chance to see if we are the right company for your long-term goals. The Company’s Legal Regulatory Group is seeking one intern for 8 weeks (June-July 2026) in our Upper Gwynedd site. The intern should expect to be working on-site at least three days per week and will have the option to work remotely up to two days per week. The Company's Legal Regulatory Group...

We are searching for the best talent for Principal Quality Engineer to join our DePuy Synthes Quality organization located in Palm Beach Gardens, Florida. The Principal Quality Engineer provides overall quality assurance leadership of on-site manufacturing areas engaged in the production of Johnson & Johnson products. Ensures manufacturing areas are meeting good manufacturing practices, international organization for standardization and any other applicable standards. The Principal Quality Engineer prepares, conducts, monitors and reports on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards; applies extensive and diversified knowledge...

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, Regulatory Policy - North America. This position is a hybrid role and can be located in Raritan, NJ or Washington, D.C. The Director, Regulatory Policy - North America,...

Purpose The Compliance Manager is responsible for the management and coordination of project and departmental support with a focus on activities linked to compliance to FDA compliance and other applicable Regulatory bodies and AbbVie requirements. Participates in maintaining quality system documentation including but not limited to Quality Manuals, AMED Standards, Global Quality Policies, and departmental SOPs. Provides necessary support for product field actions. Responsible for Product Surveillance local management review and participates in quality system management review. Oversees Global Product Surveillance CAPA program and is responsible for the site’s internal audits. Oversees internal, supplier and regulatory audits and preparation activities....

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

The Director Regulatory Affairs, US Advertising and Promotion is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching regulatory strategy and brand plan. The Director will contribute to strategic planning for the department (and departmental achievement of initiatives to meet goals and plan), manage assigned projects, and develop individual and team performance within the assigned franchise. The Director will also network and benchmark outside of AbbVie to provide for best practices and processes. Responsibilities Advise cross-functional teams on content and message consistency and best practices regarding planning and execution...

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 currently constructing an advanced manufacturing facility for production of...

Johnson and Johnson is recruiting for a Quality Operations Lead located in Irving, TX. Leads Quality Operations group to ensure that performance and quality of products conform to established company and regulatory standards. Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards. Establishes and maintains quality assurance programs, procedures, and controls. DUTIES & RESPONSIBILITIES In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position Responsible for oversighting quality engineering group in collaboration with other functional areas to ensure effective & efficient...

POSITION SUMMARY The Senior Director, Next Gen CAR-T Quality Leader is a strategic Quality leadership role responsible for shaping, executing, and overseeing the end-to-end Quality strategy for Johnson & Johnson’s next-generation CAR-T manufacturing and QC testing platform. This leader will guide the design, implementation, and commercialization of highly automated, robotics-enabled manufacturing and QC testing systems to support a transformative new cell therapy product. The role serves as the primary platform Quality responsible leader, accountable for end-to-end Quality oversight from clinical development through full commercial launch of two global manufacturing locations (US and Europe), representing a combined investment of $2.2B. The...

As an QA Technician I you will provides independent evaluation of materials, components, and products per specific instructions, and work process within the quality system. Quality and production support resource to ensure compliance with policies and procedures within an atmosphere of error prevention and continual improvement. This position is for the third Shift, Sunday to Thursday from 900pm to 500am. (Availability to work Friday or Saturday as business necessity) Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. What You’ll Work On Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Review material,...

Job Title Quality Technician We currently have an opening for a Quality Technician for the Vascular division. This role can be located at our Houston, TX location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. WHAT YOU'LL DO MAIN PURPOSE OF ROLE Performs inspection and testing of purchased materials, components and products in accordance with policy and procedures. Assists Supplier Quality Engineering with...

**Candidates must live in or near San Diego California** The Quality Planner plays a critical role within the Quality organization, ensuring high‑quality data and documentation are established to support compliant, reliable manufacturing and supply chain operations. This position focuses on the creation, maintenance, and continuous improvement of Quality Info Records, First Article Inspection (FAI) data, and Master Inspection Characteristics (MICs). The ideal candidate brings strong analytical skills, a process‑oriented mindset, and the ability to collaborate effectively across Quality, Supply Chain, and Engineering functions. Key Responsibilities Develop, review, and maintain Quality Info Records, First Article Inspection documentation, and Master Inspection...

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. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionizing the way we do R&D. We’re uniting science, technology and talent to get ahead of...

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

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

We are seeking a Senior Manager, Full Stack engineer, to serve as a technical leader in an AI first, agile product environment supporting Global Regulatory Sciences (GRS) technologies. This role is accountable for the end-to-end build and run of AI-native technology assets supporting Global Regulatory Sciences, ensuring solutions are reliable, accessible, secure, compliant, and cost-effective. The Senior Manager designs, builds, and operates AI native products where large language models, agentic workflows, and data-driven intelligence are the default paradigm—not an addon. The role blends hands-on full-stack engineering, AI product thinking, and operational ownership, with responsibility for both delivery and long-term‑ sustainability...

The Regulatory Site Office, Vaccines will work closely with the Manufacturing and Supply teams and CMC colleagues on Vaccines based projects to achieve submissions and approvals in key markets and to maintain regulatory compliance for License registrations. The RSO management and position are based in Swiftwater, PA USA. This is a hybrid position. About Sanofi We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope...

The Regulatory Site Office, Vaccines will work closely with the Manufacturing and Supply teams and CMC colleagues on Vaccines based projects to achieve submissions and approvals in key markets and to maintain regulatory compliance for License registrations. The RSO management and position are based in Swiftwater, PA USA. This is a hybrid position. About Sanofi We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope...

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. As a Senior Manager within our Global specialized Regulatory Science expert unit, you'll play a crucial role in developing innovative regulatory strategies that accelerate drug development through Model-Informed Drug Development (MIDD), Real World Evidence, and novel endpoint approaches. Working directly under Global Head, Regulatory Science — Model-Enabled Development, Real World Evidence & Novel Endpoints, you'll be responsible for hands-on project delivery, regulatory strategy submission, and direct engagement with health authorities on technical...

We are searching for the best talent for Senior Manager, Quality Assurance to join our DePuy Synthes Quality organization located in Palm Beach Gardens, FL. Responsible for the overall management and effectiveness of the key Site Quality Management Systems (Training, CAPA and NR) and risk management processes. At this level, the position has a greater degree of impact on the business results and typically, responsibility for managing a group of professionals. Key Responsibilities Implements the continuous improvement of quality systems to facilitate business and quality objectives, and compliance review and resolution processes. Alerts the organization to issues in time to...

We are searching for the best talent for Manager, Quality Engineer to join our DePuy Synthes Quality organization located in Palm Beach Gardens, Florida. The Manager, Quality Engineer is responsible for the overall management and effectiveness of Quality and Compliance execution of NPD Integrations into the Manufacturing environment, QA continuous improvement projects and risk management processes. Key Responsibilities Implements the continuous improvement of quality systems to facilitate business and quality objectives, and compliance review and resolution processes. Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business. Leads...

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

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

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

In this exciting role as a Principal Supplier Quality Engineer in Cardiac Surgery (CS), you will develop supplier quality strategies and lead supplier control activities for new product development programs based in Brooklyn Park, MN and Dexter, MI. Cardiac Surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this operating unit provides an intimate relationship with the Cardiac Surgeon and Cardiac Operating Room by offering an unparalleled depth and breadth of portfolio. Key Technologies Surgical heart valves Cardiac OR solutions (e.g., blood management, cannulae) Extracorporeal life support Coronary artery bypass grafting...

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

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...

Supplier Quality Engineer II 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. The Supplier Quality Engineer II role will drive 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...

Validation Technician - Nutrition Manufacturing - Casa Grande, AZ We are seeking a detail‑oriented Validation Technician to support validation and change control activities across equipment, systems, utilities, and processes in a regulated manufacturing environment. This role ensures that all systems meet defined requirements, comply with cGMP standards, and maintain audit‑ready documentation. 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 bodies strong and active. Millions of people around the world count on...

Senior Quality Engineer 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. We have an opening for a Sr. Quality Engineer at our Minnetonka, MN site within our Electrophysiology division. This position will provide Process/Quality Engineering support to manufacturing for commercially released product, helping to ensure delivery of highest quality product to the customer. What You’ll Work On Reduces and controls manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary...

About This Role As a Senior Associate III in Inspection Management within our Quality Assurance team, you play a pivotal role in maintaining and enhancing quality systems at the RTP facility. Your expertise in GMP activities ensures that our quality systems remain compliant with industry standards. You will lead the charge in managing site inspections, regulatory requests, and overseeing the creation and approval of GMP documents. Your ability to balance departmental workload, mentor team members, and manage key projects will significantly contribute to our team's success. This position not only ensures compliance but also drives continuous improvement, reinforcing our commitment...

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...

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Staff Compliance Engineer located in Santa Clara, CA. At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics and Digital Solutions was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in...

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. The Global Head, Regulatory Science — Model-Enabled Development, Real World Evidence & Novel Endpoints serves as a specialized center of excellence within Sanofi's Regulatory framework, driving innovation in regulatory science through advanced model-informed approaches, real world evidence and novel endpoint development. We accelerate drug development timelines by providing expert guidance on Model-Enabled Drug Development frameworks, regulatory validation of new endpoints, real-world evidence data and cutting-edge regulatory strategies across therapeutic areas. We bridge...

Join AstraZeneca as a Lead Quality Advisor, Site Quality (Development Quality). At AstraZeneca, quality is how we deliver on our mission to transform patients’ lives. We’re seeking a Lead Quality Advisor to provide GMP leadership across our development value chain—from internal Drug Substance and Drug Product to Pack & Label and clinical trial supply. In this high‑influence role, you will Build and translate robust, risk‑based cGMP standards into practice across Development Provide QA oversight of manufacturing documentation, deviations, risk assessments, and SOPs Release internal Drug Substance, Drug Product, and IMP for clinical trials (DevQ release) Lead/host regulatory inspections and contribute...

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. ...

The New Product Introduction (NPI) Engineer – Equipment Validation is responsible for supporting and executing equipment validation activities to support the successful introduction of new products into manufacturing. This role ensures that production and test equipment are properly specified, installed, qualified, and validated in compliance with internal procedures, quality system requirements, and applicable regulatory standards. The NPI Engineer partners cross-functionally with R&D, Manufacturing, Quality, and Suppliers to drive robust validation strategies, mitigate risk, and ensure equipment readiness for launch, scale-up, and sustained production. Key Responsibilities Work closely with internal Manufacturing, Quality Control, and Equipment Validation teams, as well as external...

Senior Manager, Computer Systems Validation (CSV) – Cell Therapy Location Summit, NJ Department Equipment Commissioning and Qualification Organization The Senior Manager, Computer Systems Validation (CSV), Equipment Commissioning & Qualification supports design, development, delivery, validation, maintenance, and support of GMP computerized systems at multi-use sites. This individual interacts with internal team members, peer-level customers, and external service providers, supporting multiple projects and ongoing activities to ensure regulatory compliance. The Senior Manager supervises contract and/or full-time staff to facilitate departmental deliverables and directly supports CTDO Summit. Key Responsibilities Management Lead a team of up to 9 people. Interview and hire internal/external...

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. As GRA CMC Lead within our GRA CMC & GRA Device Organization, you’ll drive global regulatory strategies for pharmaceutical and vaccine products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of drug approvals through strategic negotiations with health authorities worldwide. Ready to get started? Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the opportunity to...

Senior Quality Professional Validation At Molecular Diagnostics, we realize the potential of personalized care as the laboratory’s most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics. Position Senior Quality Professional – Validation Location Molecular Diagnostics Business Unit, Des Plaines, Illinois The Senior Quality Professional – Validation is responsible for ensuring compliance with applicable Corporate and Divisional policies and procedures. This role manages all validation activities, including protocol development, document review, controlled document storage, and resolution of problem reports....

In this exciting role as a Quality Engineer I, you will help support manufacturing validation, quality systems, product quality, and manufacturing site transfer at the Rice Creek Pharma Operations Manufacturing site in Fridley, MN. The product portfolio includes new technologies and next-generation products in the combination drug/device product space. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration...

Sr Supplier Quality Engineer Pre-Market for Cranial & Spinal Technologies Remote We are seeking a committed professional to join our team. This position is remote within the U.S., with a strong preference for candidates located in the Midwest (ideally Indiana) to support collaboration with regional suppliers. The role requires approximately 50% travel throughout the Midwest to engage directly with suppliers and support quality initiatives. Must have a valid driver's license. We value what makes you unique. Together, we can change healthcare worldwide. In this exciting role as a Senior Supplier Quality Engineer, you will have responsibility for leading a...

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...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at About 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 Regulatory...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way! Learn more at We are searching for the best talent for a Process Validation Engineer II to join our Team! This is an onsite/hybrid role. The Process Validation Engineer II will support and drive the initiative to establish a robust and...

Johnson & Johnson is currently recruiting for QA Validation Specialist II LVV! .This position will be located in Raritan, NJ. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.Janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies....

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 Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for Compliance Lead to be located in Athens, GA. This position will be accountable for the site internal quality program and external GMP audit and inspection management programs, lead and/or coordinate team...

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

This position works out of our Atlanta,GA 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. As a Senior Quality Manager, the individual will play a crucial role within Abbott’s Heart Failure organization with primary focus to maintain overall Quality Management System compliance to internal policies, applicable standards and external regulatory requirements. What You’ll Work On The incumbent defines and develops strategy for external and internal audits (Regulatory Agencies, Corporate, Notified Bodies, Certifications etc) to...

Supplier Quality Engineer This position works out of our Pomona, CA location in the Toxicology Business Unite , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Supplier Quality Engineer is part of the product development core team responsible for quality engineering deliverables including specification development, risk management, process and test method characterization and control plan development. What You’ll Work On Plans and perform...

Senior Quality Engineer This position works out of our Barceloneta location in the Vascular division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. The Senior Quality Engineer provides 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. Shift 1st- Monday to Friday 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 material, leads identification of primary root causes...

This position serves as a critical role to ensure that Alto GXP employees have the procedural tools and training to perform their job. Heavy collaboration with functional area management to create/revise Controlled Documentation, review necessary training and other procedural tools. Responsible for implementing GxP training across the Alto organization. Owns the GxP systems across the organization and works with the functional area representation to maintain CFR Part 11 Compliance and associated system validation. Assist with Inspection Readiness and have key role in supporting Regulatory Agency inspections. WHAT YOU'LL DO Lead the Quality onboarding / offboarding mandatory of Alto employees, including...

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

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

We are seeking an experienced Senior Quality Engineer who will play a pivotal role in maturing Element’s Quality Management System (QMS) towards ISO 13485 compliance and provide quality engineering expertise on Element’s on-market products. This is an incredible opportunity for someone who is passionate about being a leader that can work with significant autonomy and independent judgement to achieve our Quality goals and lead continuous improvement projects with cross-functional teams. We are looking for candidates with a solid background in medical devices (Class I-II). Experience with developing strong working relationships with both internal and external customers to influence and enable...

Quality Compliance External Affairs, Senior Specialist Quality What you will do Pharmacopeial Program Management Lead project management of major global pharmacopoeias (USP, Ph. Eur., JP, ChP), ensuring structured review and implementation of periodic updates. Coordinate cross-functional teams and site points of contact at global manufacturing sites to execute required changes in alignment with compliance timelines. Ensure all pharmacopeial changes are appropriately assessed, documented, tracked, and maintained in a current state within Amgen systems. Author compendial assessments within Amgen’s documentation management systems for audit readiness purposes. Regulatory Intelligence & Industry Engagement Proactively monitor early signals, emerging trends, and evolving regulatory...

The Director, Quality Assurance will be responsible for team leadership and subject matter expertise in Quality Operations, Facilities and Validation at the our Company's Rahway, New Jersey site. This position will serve a critical role in supporting the expansion of clinical development activities at the site with responsibilities including, but not limited to the following Execute GMP quality assurance activities directly related to facilities, equipment, and automation for clinical trial material supply capabilities. Support the design phases and operational readiness of multiple significant cross-modality capital projects that are aligned with the expanding site mission. Drive quality from design through qualification,...

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 Sr. Design Quality Engineer role to be located at Danvers, MA. The ideal candidate for the 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 embraces...

Position Senior Manager, Quality Assurance Shop Floor 2nd Shift Location Devens, MA The Senior Manager, Quality Assurance Shop Floor (QASF) 2nd Shift is a key people leader. The incumbent manages front line managers, and their teams, and will play a pivotal role in ensuring the highest quality standards in our cGMP Cell Therapy processes. The QASF organization is responsible for quality oversight of shop-floor activities at the Devens Cell Therapy Facility (CTF) including the manufacturing, release testing, and packaging of autologous drug product. The incumbent will be at the forefront of our night shift operations, fostering a culture...

In this cross-functional quality role, you will actively participate in design control activities, including research and diagnostic applications. You will ensure product and process conformance to applicable safety and quality system regulations and standards (e.g. FDA (820), ISO 13485, ISO 14971, IVDR). You will be responsible for guiding teams through the execution of design control activities in alignment with quality system requirements and current best practices to ensure the company's products and processes are safe, effective, and meet customer performance needs. You will represent quality on cross functional project teams. Position Responsibilities - Provide Quality oversight to ensure Illumina’s products...

Join a talented global team that's powering AstraZeneca to better serve patients, every day. As a Reasonable Accommodation & Employment Compliance Specialist, you will administer the full lifecycle process associated with medical and religious accommodations. This includes reviewing ADA requests for accommodation, engaging with employees in the interactive process, and providing an organizational decision on the accommodation to the leave and disability vendor and employee. You will manage complex ADA requests and maintain compliance with federal, state, and local laws related to job protection and accommodating employees with disabilities. This role will also lead US employment compliance programs and serve...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Manager, Quality Assurance at Gilead you will provide Quality Assurance leadership and oversight for Gilead’s Global Logistics operations supporting...

The Cardiac Surgery Operating Unit is a highly specialized, multidisciplinary environment dedicated to the surgical treatment of complex heart and great vessel conditions. The unit brings together cardiac surgeons, anesthesiologists, perfusionists, nurses, and technologists who work in close coordination to deliver procedures such as coronary artery bypass grafting, valve repair and replacement, and advanced structural heart interventions. Equipped with state-of-the-art technology and supported by rigorous safety and quality protocols, the unit operates with a strong focus on precision, efficiency, and optimal patient outcomes. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything...

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

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

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

The Senior Manager, GxP Strategic Document Partner supports the Associate Director of GxP Quality Document and Records Management by managing, assessing, and delivering high-impact, compliant documents and records management solutions in alignment with quality objectives, regulatory standards, and business priorities. The Senior Manager serves as a strategic document partner for assigned area(s) and/or quality system(s), leading document impact and needs analyses and partners with the business to lead Global document initiatives, supporting a functional document hierarchy which integrates the development, maintenance, and distribution of critical documents that support the organization’s strategic goals and initiatives. This role requires expertise in consulting,...

The Director, Quality Analytics is accountable for advancing the Quality Analytics Center of Excellence by delivering trusted, decision‑grade insights across Quality and GxP domains. This role leads a team that designs and scales metrics, dashboards, and advanced analytics to strengthen quality governance, operational oversight, and continuous improvement across modalities and product lifecycle stages. This role is a people manager, responsible for building and developing a high‑performing team, establishing clear priorities and operating rhythms, and ensuring analytics and AI solutions are implemented in a controlled, compliant manner suitable for regulated environments. The role partners cross‑functionally to improve data quality and reliability,...

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. Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company,...

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

Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working 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. Careers that Change Lives LOCATION This position will support the Advanced Surgical Instruments Manufacturing business 5 days onsite within Medtronic’s Surgical Innovations group located in Boulder, CO. This is an on-site role supporting the Global Operations & Supply Chain organization at the...

Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. The Sr Design Quality Engineer will play a critical role in supporting the Neuromodulation and Pelvic Health business by developing, implementing, and maintaining quality standards for new product development. This position requires close collaboration with R&D engineering and manufacturing teams to ensure compliance with regulatory and internal requirements, emphasizing the inspection, testing, and evaluation of product...

We are searching for the best talent for a Senior Supervisor, Quality Control to be based in Jacksonville, FL. About Vision Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life....

J&J MedTech is recruiting for a Senior Quality Engineer, New Product Development , located in Cincinnati, OH! At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at In this role you will be responsible...

We have an immediate opportunity for a Controls & Compliance Supervisor - CFS Americas Hub in our Lake County, Abbott Park, IL location. Abbott Park is the global corporate headquarters of Abbott Laboratories and the base in which the US Finance Shared Services center maintains operations. From this location, Finance Shared Services provides processing and expertise to Abbott divisions and affiliate companies across the Americas. The core services are in Record to Report, Order to Cash, Source to Pay and Master Data Management. The Financial Shared Services hub is part of Corporate Finance and has regional counterparts in EMEA and...

We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Jr. Customs Trade Compliance role reports to the Customs & Trade Compliance Manager and is accountable for engaging Abbott CoreDx and Transfusion's Trade compliance operations with an emphasis on Import/Export compliance and department operations while ensuring the utmost compliance with U.S. Import and regulatory requirements related to 19 CFR and 15 CFR and established internal policies and procedures....

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. The Opportunity The position of Quality Control Technician is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will perform work required to ensure Company product quality is maintained at standards set forth by Company Quality System and mandated by regulatory agencies such as the FDA, ISO, and CMDR What You'll Work On Perform testing...

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

We anticipate the application window for this opening will close on - 7 May 2026 Position Sr. Regulatory Affairs Specialist for Medtronic, Inc. located in Mounds View, MN. Responsible for developing regulatory strategies, preparing U.S. regulatory submissions, and obtaining and maintaining approval for products and therapies to markets worldwide. Assess the regulatory impact of changes to cleared & approved products and processes and coordinate the implementation of any resulting regulatory strategy. Prepare document packages for regulatory submissions from all areas of company and inspections for Food and Drug Administration Quality Systems Regulation (QSR). Compile all materials required in submissions,...

AbbVie’s diversified portfolio provides a unique mix of pharmaceutical products and direct-to-consumer aesthetic products and devices. This allows for distinct opportunities for AbbVie professionals to learn and operate in both spaces, gaining an understanding of the different industries and associated business models. The Global Compliance Audit Associate Director has the primary function to lead/manage global sales and marketing, corporate functions, and other healthcare compliance audits. The role will assist the Director with annual risk assessments and be expected to form relationships with a broad spectrum of stakeholders to understand business risks for US/International locations and recommend a thoughtful audit approach....

The Program Compliance Senior Analyst (PCSA) is responsible for monitoring and reconciliation to ensure data is accurate and compliant with 60+ individual country policies; and Abbvie’s OPPFs, procedures, and CFMs for all activity including top tier Congress activity . The PCSA is also responsible for the successful close-out of activities, ensuring financial, transparency and compliance accuracy of all costs and activity associated with events planned within AbbVie’s Business Service Group or by Third Party Vendors, as required by country specific, federal and state government reporting and regulations. The PCSA role includes the continued enhancement of Cross Border Transparency requirements by...

Our Coronary & Renal Denervation group is looking for their next Senior Principal Quality Systems Specialist. In CRDN, we love what we do. That's because we're passionate about the patients we serve around the globe and the "second life" and improved health we can give to those with Coronary Artery Disease, High Blood Pressure, and other conditions. We're also driven by the promise of Renal Denervation and its potential to change the way patients around the world manage their uncontrolled hypertension. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do....

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...

Job Summary Vertex is seeking a highly motivated and experienced Associate Director, Quality Control to join our External Manufacturing, Cell and Genetic Therapies (CGT) team. This role is pivotal in driving quality excellence and operational efficiency across our commercial CGT manufacturing sites and testing facilities. The successful candidate will lead key quality initiatives, develop and execute lifecycle management (LCM) strategies, and champion digital transformation within the Quality Control (QC) function. This is a hybrid role, offering a dynamic and collaborative work environment. Key Responsibilities Develop and execute Lifecycle Management (LCM) strategies to ensure continuous improvement, scalability and compliance across QC...

Associate Director, Patient Safety Technical Solutions Location Wilmington, DE The Patient Safety Technical Solutions Team is accountable for managing the information assets and systems owned by the Chief Medical Office (CMO), ensuring they are effectively supported and governed across the enterprise as well as for deploying system analytics and informatics expertise to meet Global Patient Safety’s (GPS) scientific, business and compliance needs. Reporting to the ‘Director; PS Technical Solutions’, the ‘ Associate Director; PS Technical Solutions ’ provides Information reporting and technical expertise across AstraZeneca’s enterprise business-critical Patient Safety Pharmacovigilance (PV) reporting systems. The role holder works within a team...

The Senior Source Quality Development Engineer (Sr. SQE) leads source quality for Direct Material suppliers that make Johnson and Johnson Electrophysiology (EP) components, putting supplier quality strategies, standards, and processes into practice. Key responsibilities Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management. Support supplier selection, qualification, ongoing monitoring, and orderly disengagement when needed. Support component qualification for NPI projects at EP with cross-functional teams and suppliers Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision. Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the...

This is a full time on-site position with M-F business hours About This Role The Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. This individual has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. The Sr. Associate II provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in a manner consistent with site and Corporate policies, cGMP, safety,...

The Manager Labeling Regulatory Affairs Strategic Labeling, develops and maintains US/EU package inserts and Company Core Data Sheets and coordinates review and approval of these documents with changing regulatory environments. The Manager leads discussions to ensure global consistency of labeling and educates team members concerning global consistency of labeling. Responsibilities Leads teams on labeling decisions based on knowledge of processes and regulations. Educates others as to new labeling regulations regarding Company core Data Sheet (CCDS), US Package Insert (USPI), Summary of Product Characteristics (SmPC), Structured Product Labeling (SPL) , or Instructions for Use ( IFUs) Reviews and assesses data to...

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

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. by The Associate Director / Director is responsible for managing the...

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...

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...

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...

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 regulatory issues with the manager as necessary and support resolution of submission issues with engineering partners, geography regulatory partners, and regulatory agencies. Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls. Provide...

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...

Senior Supplier Quality Engineer 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 a Senior Supplier Quality Engineer, you'll have the chance to be part of a team of Engineers responsible for activities related to supplier quality management, qualifying purchased materials, investigating supplier performance issues, evaluating opportunities with incoming material, and managing supplier change notifications. This position contributes to the development, establishment...

The Opportunity We are seeking an experienced Quality Systems Auditor with expertise in medical device and software auditing to support internal audit program required for compliance with global regulatory standards and collaborating with Abbott Medical Device Business Units for external inspection preparation and support. This role will s upport M edical D evice Products . What You’ll Work On I nternal audit planning, developing audit schedules and plans, performing and documenting audits and managing related following up activities including related KPI and metrics reporting. Support the development, training, and supervision of auditors to improve their ability to provide inspection readiness...

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

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

Position We are seeking an experienced Director, Regulatory Affairs to support and execute regulatory strategy across our clinical-stage development programs. In this role, you will play a key role in both shaping regulatory strategy and driving hands-on execution across assigned programs. You will provide regulatory guidance throughout the development lifecycle, ensure alignment with FDA and international regulatory requirements, and partner closely with cross-functional teams to advance programs in a compliant, efficient, and high-quality manner.This role will report directly to the SVP, Regulatory Affairs and requires a minimum of 3 days per week onsite (or more as business needs require) in...

Leads and manages Risk Based Quality Management (RBQM) activities for assigned clinical studies across all phases and various clinical development therapeutic areas. Activities include but are not limited to development and oversight of study risk management plans, collaboration with cross functional study team members and relevant stakeholders to apply RBQM principles in support of study oversight, issue resolution, and central monitoring activities. _ Your Contributions (include, but are not limited to) Acts as the Risk Management Lead at the study level and is responsible for leading the cross functional study team through the development, execution and oversight of study level...

Senior Director, Global Regulatory Strategy - Early Development & Business Development Location Boston, MA At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week . Our head office is purposely designed with collaboration in mind, providing...

Johnson & Johnson is currently recruiting a Staff Regulatory Compliance Specialist! This position can be located in Santa Clara or San Jose, California. The Staff Compliance Engineer (Senior Analyst, Enterprise Compliance) will support, maintain, and lead when necessary, the Internal Audit Program to help the site sustain a state of readiness to applicable regulatory requirements. Leads and maintains the assigned Compliance functions to ensure compliance to applicable regulations and directives such as 21 CFR 820, 21 CFR 4, ISO 13485/EN ISO 13485, ISO 14971/EN ISO 14971, European Medical Device Directive and European Medical Device Regulation, Canadian Medical Devices Regulations...

About This Role The Director of SABR Submissions Sciences is responsible for leading Global Delivery Management (GDM) function This role is globally accountable for the operational leadership of GDM function. GDM function delivers timely and quality submissions to global regulatory authorities for both major submissions and Lifecycle management. This role provides strategic leadership, optimizes resource allocation, develops initiatives, and drives operational excellence for entire GDM function. Cross functional collaboration and building trusted relationships (with Regulatory, Reg CMC, Portfolio Management etc) Leads the planning, preparation, and submission of regulatory documents (e.g., eCTD, IND, NDA) to health authorities, ensuring compliance and strategic...

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