Quality & Regulatory Jobs in Pharma & Biotech

We anticipate the application window for this opening will close on - 20 Nov 2025 Position Sr. Quality Engineer for Medtronic, Inc., located in Billerica, MA. Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Navigate various government and industry regulations including ISO 9001. Develop and execute protocols including Installation Qualification (IQ), Operational Qualification (OQ), and...

Purpose The primary focus of this position is the medical review of clinical trial SAEs including causality assessment and company analysis development combined with therapeutic area leadership. Responsibilities Contributes above the level of individual case review through leadership of individual project or initiative. Provides overall leadership to one therapeutic area in primary role; may also serve in secondary role for additional therapeutic area. May have people management responsibilities with one or more direct reports. Performs medical review of clinical SAEs. Develops Company Analysis for SUSARs. Responsible for accurate and timely communication with all clinical trial stakeholders. Performs causality...

Purpose Purpose The QC Validation Manager provides leadership and direction to the Quality Control organization pertaining to new product introduction of clinical and commercial projects. Expectations that the QC Validation Manager will maintain high quality levels on all aspects of their job while achieving high levels of efficiency. Responsibilities Communicates with Management for Quality Management Review, Quality Initiatives, etc. Attends, coordinates and presents at internal and external teleconferences pertaining to new product introductions Responsible for coordinating cross-functional activities to ensure validation timelines stay on target. Leads and influences peers and colleagues within the scope of their work Leads method validation...

Johnson and Johnson is recruiting for a Quality Management Platform Analyst, located in Wilson, NC. We need a forward-thinking, data analyst, to evaluate, road map and construct an area within our workspace in Kneat to house our method verification and transfer execution worksheets protocols and reports. 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...

Cerenovus, Inc ., part of the Medical Devices sector within Johnson & Johnson , is recruiting for an intern/Co-op for its Medical Devices Regulatory Affairs organization . At CERENOVUS, we are proud to be on the front lines of stroke care – where every second counts – and strive to give patients a new lease on life after stroke. 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...

JOB TITLE Validation Manager LOCATION 50 Northern Ave, Boston, MA, 02210 OPENINGS 1 DUTIES Provides direction and technical leadership to validation contractor(s) to achieve effective and efficient resources utilization . Employs a “hands-on approach” to leading the team, managing people, systems and equipment validation activities. Ensures that validation work follows all safety standards, conforms to end-user requirements/specifications, cGMP compliance, and that validation activities are tracked and completed within guidelines and schedule. Expected to execute tasks and responsibilities with minimal guidance demonstrating outstanding multi-tasking, problem solving and excellent communication skills, in a dynamic and challenging internal manufacturing environment....

This position is responsible for providing investigation technical support, supplier process improvement, and scientific expertise and compliance knowledge to fulfill BMS requirements to implement supplier changes. Applicants must comply with Corporate and HR Policies, Security Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function Duties/Responsibilities Perform investigations, using eQMS (Infinity) system, for Supplier Complaints including but not limited to BMS and Supplier’s processes. Create and execute Corrective Actions and Preventive Actions (CAPA) Prepare, submit and discuss finding of the investigation process with key stakeholders. Lead global investigations in collaboration with Global Quality Supplier...

Are you a strategically focused Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! 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. Within Oncology Regulatory Science and Strategy (ORSS) we bring hope and solutions to patients with unmet...

About Cardiovascular Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for...

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 and Johnson is seeking a Senior Investigation Quality Leader, located in Athens, GA. The Senior Investigation Quality Leader is responsible to ensure the generation and completion of robust investigation reports (i.e Nonconformance and Root Cause investigations). This includes,...

As a Quality Engineer, you will be developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. WHAT YOU’LL DO Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements Lead, coach, and mentor non-exempt and entry level exempt personnel Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues Design and conduct experiments for process...

Medtronic is hiring in Woolwich County, here our employees are helping us deliver on the extraordinary. We actively seek a diverse workforce at every level We require fresh ideas and inclusive insights to maintain our position as an innovative industry leader. That’s why we actively seek, attract, and develop employees who are patient-centric, passionate, and who reflect the wide variety of life experiences found among our patients. We’ve been on a three-year journey to modernize our U.S. distribution network and transform how we distribute our products. The Woolwich Distribution site is one of two new U.S. distribution hubs opened within...

Partners closely with the Regulatory Portfolio Manager. Liaises with Global Regulatory Leader and other members of the Regulatory Strategy Team to deliver the asset’s book of work within the overall drug development process. Additionally, collaborate within Regulatory Innovation & Enterprise Delivery on above project initiatives . The full-time internship will take place June - August 2026. Key Responsibilities Responsibilities include but not limited under the direction of the Regulatory Portfolio Manager (Senior Manager I) guidance Global Regulatory Support Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team...

Associate Director, Clinical Regulatory Writing Location Boston, MA Introduction to role Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca’s core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals. Accountabilities As a Clinical Regulatory Writing Associate Director, you will...

Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. 2026 Quality & Compliance Intern- Patient Service (Pharm D) reports to the Associate Director of Quality & Compliance for US Patient Services. This role is responsible for assisting in the development of quality and compliance strategies, methodologies, and roadmaps to enhance process improvements. The objective is to ensure a superior experience for both internal and external stakeholders involved in patient services across all brands. Key responsibilities...

SENIOR REGULATORY AFFAIRS SPECIALIST Location Minnesota Rice Creek East Facility (Minimum of 4 days onsite) In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to provide products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. Saving lives is part of our everyday DNA. Real people with debilitating conditions can now be given back active lives through the restorative therapies that we provide. Therefore, we are looking for a passionate Senior Regulatory Affairs Specialist who has direct...

Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare. Join us for a career in IT that changes lives. Careers that Change Lives A Day in the Life POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY...

International Regulatory Affairs Specialist II 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 are currently hiring an International Regulatory Affairs Specialist I I to work on-site at our Plymouth, MN location. This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission review of documentation for International geographies ( primarily China ) regulatory registration, ensuring products and procedures comply with regul ations . Additionally, w ill support necessary regulatory...

This position works out of our Pleasanton, CA location in under the Medical Device, Heart Failure Division. As the Supplier Development Quality Engineer Lead you will be responsible for implementing and maintaining an effective Quality System, planning, executing, and documenting audits of external suppliers to ensure compliance with FDA, ISO 13485, and internal quality standards. This role drives supplier performance improvements and collaborates cross-functionally to uphold regulatory and operational excellence. What You’ll Work On Work cross-functionally to lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, product and process planning, quality audits, and...

WHAT YOU’LL DO We are recruiting for a Regulatory Operations Specialist I, to join our team in the Sylmar, CA location. In this role, you will be responsible for specialized level work assignments and/or analyses, evaluation, preparation, and management of global regulatory product releases and general support of global regulatory activities. Responsibilities Daily support of product releases by preparing Global Trade Services (GTS) licenses for products, countries and business partners allowing shipment of product to achieve departmental and organizational objectives . Responsible for following SOPs for managing GTS licenses, additional release authorizations (ARAs) and tender support and overall regulatory...

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to Career development with an international company where you 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 a high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path...

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Validation Engineer II will help support the Radiopharmaceutical facility and GMP operations in Indianapolis. The Validation Engineer II will be responsible for the drafting and executing commissioning, qualification, and validation (CQV) documents and protocols which support the...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families The Facilities Compliance Team is responsible for managing change controls, CAPAs and deviation intake and closure across GMP activities in the following areas - Metrology, Engineering, Facilities, Utilities, Validation and Capital Projects. The responsibilities of the team primarily extend to owning deviations relating to facilities, equipment and utilities and their...

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

Customs & Trade Compliance Junior Analyst This position works out of our Columbus, Ohio Easton Square location in the Nutrition Division . Primary Function/Primary Goals/Objectives Provide technical and analytical support for customs and trade compliance matters at the site/division level, ensuring compliance with all relevant customs regulations and trade laws and regulations, including 19CFR, 15CFR, FDA, USDA, and other US regulatory agency requirements. Operates with general direction and supervision from the Manager. Incumbent is accountable for compliant importation of goods and services (including machinery), as well as proper classification and valuation. Failure to comply is a violation of law...

PURPOSE The Supplier Risk Management, Senior Specialist is a member of the Supplier & Vendor Quality group in R&D Quality (RDQ). This role is to assist in the execution of GxP supplier risk management activities to ensure quality of the GxP system, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness. May lead targeted activities as directed by SVQ management MAIN REPONSIBILITIES | DUTIES Main responsibilities will include, but are not limited to Business Advisor & Portfolio Oversight Manage the Janssen R&D Approved Supplier List (ASL) including addition of newly qualified suppliers, maintenance of...

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

This position works out of our Alameda, CA office in the Lingo Division. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. This position is responsible for activities related to design control; qualification; specification and corrective and preventative action of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. What You’ll Work...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Senior Specialist, Associate Process Validation Engineer, Cell Therapy provides process validation support to the Devens Cell Therapy Facility (CTF). The...

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Our Company is currently seeking candidates for the position of Associate Specialist, within the Quality Control team, specifically for the Animal Biologics group at its Elkhorn, Nebraska facility. This position will work,...

The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals Within our Research Labs division, the Quality Assurance group is seeking 1 co-op who will work collaboratively in a team environment to help advance Quality throughout the drug development life cycle. Global Development Quality Co-Op Opportunity (1 position) The role of Global Development Quality (GDQ) within our Company's Research...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. Within our Research Labs division, the Quality Assurance group is seeking 2 interns who will work collaboratively in a team environment to help advance Quality throughout the drug development life cycle. Global Development Quality Intern ship Opportunit y ( 2 position s ) The role of Global Development Quality (GDQ)...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities can provide you with great development and a chance to see if our company is the right company for your long-term goals. Our company's Global Clinical Trial Operations (GCTO) team is currently recruiting for summer 2026 Interns. GCTO is a global organization operating in over 50 countries and is responsible in the delivery of our company's diverse development portfolio. It is critical that for all company-sponsored clinical trials that patient safety, high quality data and compliance with company requirements...

The Data Governance – compliance specialist is vital to ensuring robust governance of consent and sample management for both primary and secondary sample uses across QM&G. This role is responsible for reviewing and optimizing Informed Consent Forms (ICFs), overseeing sample collection, retention, and withdrawal of consent processes, and ensuring adherence to all relevant internal and external regulations. The specialist collaborates closely with Legal, R&D, and QM&G teams to coordinate cross-functional governance projects, facilitate continuous process improvement, and drive operational excellence in sample governance. Additionally, the role provides critical operational and project support across various governance initiatives, aiding in the planning,...

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...

This position, Associate Director Regulatory Affairs , works out of our San Diego, CA location in the Infectious Diseases Division. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs. 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. We are seeking a highly knowledgeable individual to combine expertise in scientific, regulatory, and business issues...

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

This position works out of our Santa Clara, CA location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Sr. Technician , you’ll support manufacturing in the Structural Heart Division of Abbott, reporting to the Manager of Quality. Conduct functional testing as required by component drawings, manufacturing instructions, and/or test instructions Responsible for performing in-process and final components, subassembly and product inspection. Measure component dimensions per requirements or inspection plans. Records inspection and...

About the Role The Quality Engineering (QE) Senior Associate I is responsible for the oversight of key functional, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The QE Senior Associate I will perform all duties in a manner consistent with site and corporate policies, cGMPs, safety, environmental and human resources policies and procedures and be proficient in their understanding of the Biogen Quality Systems and apply that knowledge in coaching and continuous improvement for all Quality Systems cross-functionally. The QE Senior Associate I will provide quality oversight of Engineering, Manufacturing, Maintenance and Facilities...

Summary Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. We are seeking a highly experienced and dynamic Head (VP) of Regulatory Affairs and Pharmacovigilance to lead regulatory and safety strategies at the Biogen West Coast Hub (WCH). This leader will be accountable for shaping and executing comprehensive regulatory strategies to enable timely, successful interactions with global health authorities. You will lead and...

Director, Regulatory Affairs Department Regulatory Affairs Location San Diego We are seeking an experienced and innovative Director in Regulatory Affairs (clinical and nonclinical). This Global Regulatory Lead (GRL) position will report to the Head of Regulatory Affairs and will oversee and/or manage regulatory functions and direct reports within RayzeBio . Responsibility expectations will be commensurate with experience. Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Global Regulatory Lead for a cutting edge RPT program Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products, including timing and nature of global regulatory interactions....

Quality Compliance Manager What you will do Let’s do this! Let’s change the world! We are hiring a Quality Compliance Manager, which will operate within the General Medicine & Obesity Quality Therapeutic Area. In this vital role you will provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program. (protocol development, database lock, and regulatory submissions/ approvals). Reporting to the Quality Compliance Associate Director, you will oversee quality management and ensure compliance for global and local clinical trials by supporting...

You will act as the Global or Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic area. You will typically be assigned a portfolio of products or projects or key Gilead assets to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance...

Job Responsibilities Independently and proactively initiate and drive the planning, execution, and completion of change management projects Develop and implement strategies to mitigate risks within the change management process and change control system. Facilitate and present at cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS and regulatory expectations. Responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals. Develop, deliver, and improve the change management program for various levels of the organization, while also ensuring training...

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 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 teamwork,...

We are searching for the best talent for Senior Regulatory Affairs Program Lead to support our Electrophysiology business. This role will be based in Irvine, CA and work a Flex/Hybrid schedule with 3 days per week in office. Purpose Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. You will be responsible for Ensures compliance with global regulations and regulating agencies. Interpret the intent of regulations and policies and provide such information to project teams and management. Instills and drive a regulatory culture. Establish and support...

Reporting to the VP of Human Biology, the Head of Target Validation is responsible for leading the global Target Validation group within the Target Discovery Department . This team is responsible for designing and executing in vitro biology studies to validate novel targets from functional genomics based approaches linking target modulation to a disease phenotype . This team works in partnership with chemical biology, drug discovery platform teams and the research units to generate target data packages to support C2TV and C2T decisions for our priority disease areas, including respiratory, hepatology, neurodegeneration, oncology, renal and infectious diseases. Responsibilities Leading and...

The Senior Manager, Regulatory Affairs, Device works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research & Development (R&D) organizations. Represents RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. Additional Responsibilities Include Prepares device regulatory product strategies. Prepares and manages regulatory submissions, including new applications...

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 Quality Analyst to be located in Shepherdsville, Kentucky. The Quality Analyst is responsible for the oversight and execution of Quality Management Systems and compliance at the Distribution Center. The Quality...

This position works out of our Santa Clara, CA, location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We are seeking a skilled Quality Engineer to assume primary responsibilities in test method validation. The ideal candidate will possess extensive knowledge in this area. Additionally, the QE may be tasked with equipment/tooling logistics responsibilities, contingent upon their expertise and organizational needs. The role also encompasses supporting receiving inspections, in-house manufacturing inspections, and managing nonconformance reports....

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

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

Purpose Support the AbbVie Technical Operations Functions and the AbbVie Technical Centers worldwide. Resolve analytical issues associated with commercial and research & development API’s and drug products. Provides technical support to cross-functional teams within and outside of MS&T during development, commercial launch or problem solving for a given API or drug product. Accountable for test results, project reports and experiments in support of process development, validation activities and Technical Transfers while maintaining and meeting the highest standards in quality, customer service and regulatory compliance. Responsibilities Maintains and applies state-of-the-art chemical engineering knowledge. Evaluates and integrates relevant engineering advances for improving...

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...

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Position Description This is a day/night shift position, 12.5 hour ( 600 AM - 630 PM; 600PM-630AM) rotation ( 2-2-3). The Vaccine Manufacturing Facility Lead Technician is an excellent opportunity for highly motivated individuals with expertise working in aseptic production and manufacturing operations. The Lead Technician is a...

The primary responsibilities include, but are not limited to General secretarial/clerical tasks including scheduling of complex meetings, management of calendar, filing of monthly expense reports for multiple therapeutic area regulatory liaisons. General support of the Upper Gwynedd‐based staff, as needed, with ordering supplies, ad‐hoc meeting support, good office management practices, etc. to ensure a well‐functioning environment. Scheduling domestic and complex, multi-leg and international travel, including processing of Visas/Passports. Supporting Team Sites, SharePoint Sites, and other communication channels. Coordination and collaboration with other team members across the organization, including coordination of special projects within the division/area. Education High School Diploma required....

Medtronic – Milwaukee, WI manufactures spinal implants and Brain/ENT instrument components. As a member of Supplier Quality Engineering, you will be responsible for management of external suppliers to Medtronic, Milwaukee. You will lead oversight of supplied products, ensuring conformance to purchased material requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations. 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...

Job Tite Summer 2026 Intern - Validation Team Location Swiftwater, PA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Our team is looking for a summer intern to assist in lab experiments, development and validation studies for cleaning and shipping validation with different vaccine products. In addition, the intern will also support collecting and analyzing...

Job Title Quality Assurance Manager This position will work out of our Temecula, CA location in our Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. THIS IS AN ONSITE DAILY REQUIRED POSITION. Manages experienced QA professionals who exercise latitude and independence in their assignments. Often heads one or more sections/functions or a small quality department. Interprets policies , processes and procedures that may affect sections and subordinate work units. Assignments are defined in terms of activities and objectives. Work is reviewed for adequacy in meeting objectives. MAIN RESPONSIBILITIES Interacts frequently...

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...

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Regulatory Affairs Intern will support the Regulatory Affairs team in preparing documentation, tracking submissions, and assisting with project coordination. This internship offers exposure to regulatory processes in the pharmaceutical industry and provides hands-on experience in a cross-functional...

The Senior Specialist, Quality Assurance , is accountable to monitor and track process performance related to key Shop Floor quality assurance quality tasks and other operational tasks through data and analytics; to own, review or approve Floor Quality GxP records including but not limited to procedures, CAPAs, change controls, impact assessments, documentation, or deviations; and represents SFQA at relevant governance forums. Additionally, the incumbent shall to support deviation approval, alarm approval, other Quality System Records, or batch record review as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. The Manager , IT Risk and Compliance is a key member of the Security Risk Compliance (SRC) - DP team and works closely with the legal Privacy & Data Ethics (P&DE) team, and other IT teams to ensure privacy program and controls are in place. They will serve as a subject matter expert on Information Security and Privacy principles; company policies and standards; and regulatory requirements as they pertain to data privacy. The person in this position will be required...

Manager, Quality Assurance Key Knowledge and Skills Proficient in GMPs and/or GLPs. Proficient in application of QA principles, concepts, industry practices, and standards. Demonstrates ability to effectively manage multiple projects/priorities. Has proven analytical and conceptual skills. Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes Demonstrates excellent verbal communication, technical writing and interpersonal skills. Demonstrates working knowledge and good proficiency in Microsoft Office applications. Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is beneficial. Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or...

Job Responsibilities Maintains overall project portfolios across Global Quality Monitors progress, manage risks, and ensure projects are delivered on time Drive end-to-end planning and execution of global quality initiatives, including detailed project plans, timelines, and resource management Collaborate with Project Leads and Quality leadership to monitor progress, manage risks, and communicate outcomes across the network Captures and manages Quality Systems enhancements and integrations to various platforms and ensures timely and effective implementation Support the annual Quality Planning process in alignment with corporate objectives Facilitate regular project updates, steering committee meetings, quality forums, and executive reporting Develop, organize, and maintain comprehensive...

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 Manager, Regulatory Medical Writing to support one or more of our therapeutic areas in within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting (IDAR) business. The position may be in...

At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. 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...

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

Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Supplier Quality Engineer II to be located in Danvers, MA . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at 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...

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

This is a summer internship position on the MSAT Aseptic and Environmental Controls (AEC) Validation team. The primary focus of the MSAT AEC team is to ensure the compliance of aseptic processes and environmental control systems for Cell Therapy Manufacturing Operations at Bristol Myers Squibb’s GMP facility in Bothell, WA. The internship position will focus on creating training tools and job aids for AEC-owned processes such as aseptic process simulation (APS), cleanroom reclassification (CRC), environmental monitoring performance qualification (EMPQ), and non-routine simulation (NRS). The internship will focus on creating educational resources and training tools to enhance cross-functional understanding of AEC...

At Medtronic, we’re on a mission to alleviate pain, restore health, and extend life. As a Senior Quality Systems Specialist , you will play a critical role in ensuring compliance with global regulatory requirements while helping to continuously improve our quality system to support innovation and patient safety. This is your opportunity to apply your quality systems expertise in a collaborative environment where your work truly matters. As a Senior Quality Systems Specialist, you will Lead and support Quality System processes , such as CAPA (Corrective and Preventive Action), Internal Audits, Management Review, and Document Control. Serve as a subject...

The Brooklyn Center facility also known as Medtronic Electronics Components Center (MECC) supports the production of components used in devices for a variety of Medtronic Operating Units (OUs). This role reports to the Operations Quality Manager at MECC. Key aspects of this role include being a Quality team member on multiple new product development projects as well as existing manufacturing lines, collaborating with customer sites (downstream Medtronic facilities), participating in a culture of collaboration and compliance in one of the Components Focus Factory (Includes Connectors/Molding, Capacitors, TDCO, and Feedthroughs), execute day to day operations, and execute continuous improvement to reduce...

Software Engineer - Data Quality This Opportunity Patients, doctors, and medical researchers deserve the same cutting-edge technological innovations that have transformed other industries. We're on the lookout for passionate software engineers who are eager to apply their skills to revolutionize healthcare. If you're excited by the challenge of using technology to improve lives and drive real change, we’d love to have you join our team. In this position, you will be building online services, automation, and tooling to monitor and ensure our data continues to meet Truveta’s high quality standards. This opportunity requires creative problem solving and...

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

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...

This position will support a swing shift of 12 noon to 12 midnight on a rotating 2-2-3 schedule About This Role The Quality Assurance Associate III (Swing Shift) is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. Activities include but are not limited to review of GMP raw data for compliance, review of GMP documentation to support batch disposition, review/approval of GMP procedures, protocols and reports, GxP Quality systems-related training, identify gaps in existing Quality systems and propose solutions to site management. What You’ll...

Johnson & Johnson is hiring for a Quality Technician II – Shockwave Medica l to join our team located in Santa Clara, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment...

Johnson & Johnson is recruiting for a Tax Technology Manager – Tax Reporting and Compliance Solutions to be located in New Brunswick, NJ. Key Responsibilities Lead a team of administrators supporting Tax Reporting and Compliance Tools (e.g. OneSource Tax Provision, Corptax, J&J Audit Manager, etc.) Serve as product owner and administrator for GTW and manage external resource supporting GTW maintenance. Identify, evaluate and execute solutions to transition GTW capabilities to new tools and decommission GTW. Ensure tax tools & infrastructure are sox complaint and operating effectively to support timely reporting and compliance cycles. Evaluate and deploy tax technology and process...

Johnson & Johnson is recruiting for a Sr. Project Manager for Innovative Medicine Quality & Compliance located in Horsham, PA, with considerations given to New Brunswick, NJ, Raritan, NJ and Titusville, NJ. 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 The Sr. Project Manager for Innovative Medicine Quality & Compliance...

Johnson & Johnson is recruiting for a Project Manager for Innovative Medicine Quality & Compliance located in Horsham, PA, with considerations given to New Brunswick, NJ, Raritan, NJ and Titusville, NJ. 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 The Project Manager for Innovative Medicine Quality & Compliance is responsible...

Johnson & Johnson is recruiting for a Project Leader for Innovative Medicine Quality & Compliance located in Horsham, PA, with considerations given to New Brunswick, NJ, Raritan, NJ and Titusville, NJ. 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 The Project Leader for Innovative Medicine Quality & Compliance is responsible...

Quality Engineer This position works out of our Arecibo location in the CRM division and support the first shift (Monday to Friday) . As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. As the Quality Engineer, you’ll Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. What You’ll Do Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Identifies...

Quality Technician I (2nd Shift) This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer Technician I, you will support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong...

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

Technician I Quality Assurance The Incoming QA Specialist will serve as a key contributor to the Princeton Quality Operations team, with the potential to evolve into the Incoming QA Process Owner and Subject Matter Expert (SME). This role is designed to centralize and enhance incoming quality processes, driving operational excellence and sustainable performance. It also serves as a developmental pathway for future leadership opportunities, including succession into the Quality Supervisor role. What You’ll Work On Performs visual, dimensional and functional inspection and testing according to documented policies and procedures and records them as prescribed. Assists engineering in providing manufacturing...

Manager Quality Assurance II (Design Quality) This position works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine (TM) , 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 Manager Quality Assurance II (Design Quality) will provide leadership, oversight, and project management covering new product development and on-market design changes as related to Abbott's Quality System for assays and...

Senior Development Quality Manager This position works out of our Menlo Park, CA 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. We are seeking a passionate Senior Development Quality Manager to lead and develop an engineering team responsible for operations quality, design changes, transfer projects, and post-market surveillance within assigned product areas. The manager will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring...

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 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...

The Senior Director, Regulatory Submission Management champions functional and cross-functional project and submission management excellence. The incumbent is expected to apply deep subject matter expertise in project and submission management to lead and identify opportunities, shape objectives and drive execution of key functional and corporate objectives. This role will be responsible for driving timeline risk mitigation and contingency planning. Key Duties and Responsibilities Provide strategic and operational project, submission and program leadership activities at all stages of the lifecycle (initiation through closeout). Drive communication cross-functionally and with senior leaders on project, submission and program planning topics including timelines, status, risks...

Job Title Customer Quality Statistician This position works out of our Sylmar, CA location. This is an onsite role . As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. MAIN PURPOSE OF ROLE The Statistician performs data analysis according to requirements of statistical plans and seeks to design meaningful studies to assess the performance of implantable products within the Cardiac Rhythm Management business unit (e.g., leadless pacemakers, defibrillators, cardiac leads). The statistician uses statistical software, such as R or Minitab, to...

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 looking for the best talent in Enterprise Quality for 2026. We are seeking highly motivated and meticulous Sophomores, Juniors and rising Seniors for Spring Co-ops within the Enterprise Quality organization. We work on a “hybrid model”. This means that you will be asked to report on site three (3) times a week and can work remotely two (2) times a week. If...

SENIOR REGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR Onsite Position Located at Our UCI Facility with a Minimum of 4 Days Onsite In the Neurovascular Operating Unit, we are committed to delivering meaningful innovation to advance stroke treatment. You can view more about the business and our products at Medtronic Neurovascular. Our goal as an operating unit is to ensure that we utilize the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. Whatever your specialty or ambitions, you can make a difference Provide strategic input and technical guidance...

In Coronary and Renal Denervation, 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. In-person exchanges are invaluable to our work. We’re working a minimum of 4...

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. Learning Center of Excellence (CoE) The CoE is the powerhouse of...

The Senior Manager, Regulatory Affairs, Device works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research & Development (R&D) organizations. Represents RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. Additional Responsibilities Include Prepares device regulatory product strategies. Prepares and manages regulatory submissions, including new applications...

The Logistics, Compliance and Engineering (LCE) intern will be a part of a cross functional team that concentrates on deviation management, change control, cold chain management, technology support, and operational efficiency projects in support of the North America Supply Chain Management (NASCM) organization. The LCE intern will collaborate with Operations, Quality, Automation, and Validation to drive change in a collaborative manner. The candidate will gain some understanding of cGMPs and cGDPs and will be tasked with a problem(s) to solve while contributing to multiple projects and activities across the facility and North America transportation network as required. The individual must...

In partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be accountable for the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach....

This internship position in Research & Development Quality (RDQ) offers education and exposure across various fields, including, Non-Clinical Quality, Product Development Quality, Clinical Quality, Pharmacovigilance Quality, Quality Risk Management, and Innovative Capabilities. We are seeking a self-motivated student eager to gain real-world experience in the pharmaceutical industry. The intern will work closely with professional mentors to hone their skills and build a professional network. Location New Brunswick, NJ and Princeton, NJ area. The starting hourly compensation for this assignment is within the range of $23.00 to $34.00/hr. Please note that the final individual compensation and any applicable benefits will be...

The Coronary and Renal Denervation (CRDN) division is focused on therapies that are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI) while leading the way with the transformational renal denervation therapy, recently approved in the U.S. and which has the potential to be a powerful tool in battling the global hypertension epidemic. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we...

Johnson & Johnson is recruiting for a Manager, Compliance Data Enablement, Global Operations. This position can be located at any US J&J location with a preference for Westchester, PA Titusville or New Brunswick, NJ. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) North America- Requisition #R-030032 Beerse Belgium & High Wycombe, UK – Requisition# R-032583 Bogota Colombia- Requisition#R-032584 Remember,...

Engineer II Quality Systems We are currently seeking a highly capable Engineer II Quality Systems to support Abbott’s Structural Heart (SH) Division at our Westfield, IN location. 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. In this role, you will establish and maintain effective structures to ensure consistent implementation of quality systems at Abbott. Create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidances and standards (LRGS). What You’ll Work On Identify internal requirements...

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

Manager, Quality and Validation This position works out of our Lake Forest, IL location in the Transfusion Medicine 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. As the Manager, Quality and Validation , you’ll have the chance to lead the team of Quality supervisors/engineers/technicians to support Manufacturing, Supplier Development, New Product Development, and Quality Systems. Directs projects to ensure the manufacture of high-quality product and...

Quality Assurance Specialist This position works out of our Dallas, TX location in the Transfusion Medicine , 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 primary function of the Quality Assurance Specialist is to help manage the audit process. Acts as a team member to complete assigned site audit / compliance projects including all interrelated activities. Identifies and elevates critical issues. Participates in...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. Our company's Global Pharmacovigilance Quality (PV QA) team is focused on advancing patient care and promoting safe and effective use of our companies' medicinal products and vaccines. The team ensures that the pharmacovigilance (PV) activities performed by Research and Develpoment and Human Health (HH) comply with the relevant procedures and regulations across...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Manufacturing Division can provide you with great development and a chance to see if we are the right company for your long-term goals. Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality, and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers we create an interdependent global manufacturing network dedicated to delivering a...

The Global Quality Large Molecule Analytical Sciences (GQLMAS) team is responsible for the establishment and performance of commercial large molecule analytical techniques, including method development, validation, troubleshooting, transfers as well as stocking and supplying critical reagents to global laboratories. We collaborate with both internal teams and outsourced partners. Our team is fast paced, highly motivated, and focused on advancing our Company’s large molecule pipeline as well as supporting growth and performance of existing licensed products. Specific job responsibilities could include analytical method development, troubleshooting, validation, sample testing supporting process development/changes, and logistical support for sample management and shipments, all while...

The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals Team Overview The Global Regulatory Affairs and Clinical Safety ( GRACS ) Regulatory Digital Health (RDH) team assists in bringing new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. Join us at our company Research Labs for an exciting summer internship opportunity within the Global Regulatory Chemistry, Manufacturing and Controls (CMC) group. As a summer intern, you'll have the chance to make a meaningful impact on public health by contributing to the regulatory processes of our company medicines and gain comprehensive...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. The Regulatory Data Science Service is part of the Operations, Process and Systems team within Global Regulatory Affairs and Clinical Safety. The Regulatory Data Science Service team employs Machine Learning, AI and advanced analytics and statistics to evaluate large business and regulatory datasets to drive predictive/prescriptive analytics, trend analyses and other strategic...

Our Manufacturing Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time. The 2026 Global Supplier Quality Internship will have a duration of 10-12weeks during the summer months. The Supplier Quality Intern, with guidance from the Director/ Associate Director, will have the opportunity to work on strategic goals for the business. The incumbent will have the opportunity to drive project(s) through the organization, participate on...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. The Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution team is seeking a summer intern. The intern will be a fully-functioning member of the team and will be assigned to lead a variety of process improvement projects within Global Regulatory Affairs and Clinical Safety in support of business development...

The Future Talent Program offers internships lasting up to 12 weeks, featuring one or more projects designed to enhance your skills and provide insight into our company’s culture and long-term opportunities. These internships within our Research and Development Division offer valuable professional development and an opportunity to explore if our company aligns with your career goals. The Regulatory Planning and Publishing (RPP) team is dedicated to driving innovative quality planning, ensuring excellence in publishing and delivery, and maintaining compliance for regulatory submissions worldwide. Regulatory Planning and Publishing drives innovation through collaboration, and a commitment to quality and compliance in alignment...

Specific Education & Experience Requirements 5+ years of experience in Regulatory Affairs or other relevant industry experience. Degree in a scientific field is preferred. Specific Job Responsibilities Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications (e.g. IND, CTAs), and marketing authorizations), original, marketing authorization applications for territories other than the US and EU and for...

Specific Education & Experience Requirements 10+ years of experience in Regulatory Affairs or other relevant industry experience. Degree in a scientific field is preferred. Specific Job Responsibilities Responsible for preparing and/or overseeing the preparation of technically complex regulatory submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. May direct others in accomplishing Corporate Objectives. Responsible for submitting complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original...

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

We empower healthcare professionals with world-class technology to personalize patient care, anytime, anywhere. Through connected solutions seamlessly integrated into clinical practice, we help predict and prevent dangerous and costly complications, from hospital to home. We are the leader in the equitable delivery of care, committed to reducing disparities in outcomes, expanding access, and helping to protect more patients in more places. 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...

Your skills could be critical in helping our teams accelerate progress. The Submission Lead is responsible for the planning, co-ordination and tracking of regulatory submission activities for assigned programs at Sanofi. The Submission Lead is a senior team member with the expectation and accountability to drive Global Simultaneous Submission (GSS) filing execution plans for Sanofi’s priority portfolio. The Submission Lead is also the GRO Submissions Management focal point for Mergers & Acquisitions integration and Joint Venture project teams and is directly involved in relationship building, ensuring achievement of business goals and protecting business continuity We are an innovative global healthcare...

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

Your skills could be critical in helping our teams accelerate progress. The Submission Lead is responsible for the planning, co-ordination and tracking of regulatory submission activities for assigned programs at Sanofi. The Submission Lead is a senior team member with the expectation and accountability to drive Global Simultaneous Submission (GSS) filing execution plans for Sanofi’s priority portfolio. The Submission Lead is also the GRO Submissions Management focal point for Mergers & Acquisitions integration and Joint Venture project teams and is directly involved in relationship building, ensuring achievement of business goals and protecting business continuity. About Sanofi We’re an R&D-driven, AI-powered...

Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. Intern will be joining the Regulatory Affairs U.S. Advertising and Promotion (USAP) Standards Team. The Standards Team leads USAP through department-wide initiatives, influences process improvements and fosters the review of compliant promotional and R&D communications. Key responsibilities may include Learning the FDA Regulations on Drug Advertising & Promotion Understanding the detailed USAP activities Creating reports, including metrics, department highlights and communications Attending meetings Creating presentation materials...

Purpose Promotes risk management strategy excellence through the development and application of a structured, iterative, end-to-end lifecycle risk management framework. Responsibilities Serve as the subject matter expert on Risk Management Strategy, advising and participating in various scientific discussions and activities with internal stakeholders. Advise Product Safety Teams (PST) and relevant AbbVie asset strategy teams on risk management strategies, medication error prevention, and benefit-risk assessments to support product development programs, new marketing applications, and marketed products. Collaborates with the TA leads and PST leadership on early drug development approaches to anticipate and further characterize specific risks for an asset, risks that...

Johnson & Johnson is hiring for a Principal Quality Engineer – Shockwave Medica l to join our team located in Santa Clara, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Manufacturing Operations is responsible for supporting large scale mammalian cell culture and multi-stage large scale chromatography manufacturing operations as part of a 24/7 large-scale therapeutic protein or vaccine manufacturing facility. Operation’s main functions are leading deviation investigations and managing CAPA Implementation, partnering with direct manufacturing staff for enhancing and improving...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Sanofi is an innovative global healthcare company with one purpose to pursue scientific miracles to improve lives. Our team strives to transform the practice of medicine, connecting our science to communities in meaningful ways. Within our Sanofi Manufacturing & Supply Ambition, we’re redefining our strategy, culture, and processes to make...

Careers That Change Lives In this exciting role as a Senior Quality Engineer in Medtronic ’ s Surveillance process within the quality organization s , the incumbent will contribute to the Post Market Surveillance document writing process to ensure compliance to regulations and expectations of Regulatory Bodies. This is a scientific (engineering, technical, medical) writing position. This individual will partner with other teams such as Quality/Reliability, Clinical, Regulatory Affairs, Product Development, Medical Safety, and Statisticians to collaborate and execute tasks in a timely manner. Responsibilities may include the following and other duties may be assigned. Contributes and authors Post...

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. Leading product escalations across cross functional groups Responsible for monitoring product performance, complaint investigations, and evaluating quality issues impacting released product Responsible for Design Assurance activities supporting changes to commercial products. Mentor team members through technical problem solving including CAPA investigations...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities can provide you with great development and a chance to see if we are the right company for your long-term goals. Our company's Global Clinical Trial Operations (GCTO) team is currently recruiting for summer interns. GCTO is a global organization operating in over 50 countries and is responsible in the delivery of our company's diverse development portfolio. It is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are...

Quality Technician I As the Quality Technician I, you will support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This role is for the 2nd shift. What You’ll Work On Ensures that all evidence documentation complies with governing procedures. Audits and verifies processes such as line verification or...

Quality Technician I As the Quality Engineer Technician I, you will support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. What You’ll Work On Ensures that all evidence documentation complies with governing procedures. Audits and verifies processes such as line verification or environmental conformity to prevent quality system...

About BioLife Plasma Takeda offers a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. We are certified...

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

Purpose Primarily responsible for the execution of the Pharmacovigilance (PV) audit program, including scheduling, planning, reporting and resolution of PV audits. Ensuring alignment with RDQA policies and procedures wherever possible and leading the development and implementation of the AbbVie quality system. Leadership and oversight of key audit program (system, process or affiliate) level risk-based decision making to assure a comprehensive audit program. Provision of advice and support on PV and quality topics to business partners to ensure compliance with worldwide PV requirements and expectations. Responsibilities · Assures quality and compliance in a regulated environment that includes worldwide regulations, country specific...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Senior Specialist, QC Compliance is responsible for leading QC deviation, laboratory investigations, CAPAs and change control. Shift Available Sunday -...

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 Manager, Regulatory Program Manager - Oncology. This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; Horsham, PA; or Spring House, PA. The Manager,...

Digital Chemistry, Manufacturing, and Controls ( dCMC ) is a cross-divisional digital transformation initiative that will enable the pipeline by establishing a digital continuum of data from development through manufacturing for our products and processes . dCMC intends to deliver Increased productivity and speed to clinic/market Accelerated timelines for site, filing, and launch readiness Improved access to product and process data Streamlined transfer of process and product knowledge with reduced error rates A key enabler of these outcomes is implementation of digital solutions that will install the foundational capabilities needed to realize dCMC’s vision of frictionless flow of data from...

Responsibilities may include the following and other duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property. Performs a variety of qualitative tests or qualitative assays on samples, and to aid in maintenance and certification of test instruments and apparatus to ensure compliance. Performs required inspections, checks, analysis and documentation of studies. Prepares and monitors quality statistics and reports. Reviews production records for conformance to procedures. Conducts...

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

This position works onsite in our Sylmar CA location in the Cardiac Rythym Management Division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. The Software Quality Engineer II is responsible for Software Quality relative to the design and development of company products, software reliability, developing and maintaining processes and procedures, and assuring adherence to the software development lifecycle across Abbott. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting...

About the Role As a Quality Control (QC) Supervisor at Takeda, you will lead daily QC laboratory operations with a focus on microbiological testing, compliance, and process excellence. You will help ensure product integrity through method execution, investigations, and project leadership—directly supporting Takeda's mission to deliver high-quality therapies to patients. We ask that you have hands-on microbiology expertise, method troubleshooting, and leadership in regulatory environments. Swing Shift Monday – Friday 200 PM – 1030 PM How you will Contribute Oversee routine and complex laboratory testing to support manufacturing operations, validation studies, and batch release—especially in microbiology. Perform and support microbiological...

Beam is seeking a self-motivated Quality Control Co-op to join our Quality team from January through June 2026 . The Quality Control Co-op will learn and explore in the field of cell and gene therapy. The Co-op will support building assay automation capabilities using liquid handlers for programs in clinical development. These workstreams encompass, but are not limited to, product quality release testing assays such as next-generation sequencing and functional bioassays. The Co-op will be expected to support feasibility testing of methods on the liquid handlers and compile data for analysis. In this role, you will gain insights into industry...

The Senior Quality Specialist will provide QA support for manufacturing operations, analytical laboratory operations, and materials management for the internal programs at Vertex Manufacturing Center (VMC), Boston, MA. The position will be a part of the QA operation floor support team. This role will review & support activities related to product disposition, including batch data, batch records, deviations, in-process data, EM data, QC release testing, and other quality systems documentation. The Senior Quality Specialist supports or executes daily activities related to equipment or instrumentation supporting Facilities, Utilities, Manufacturing, and Labs. The position will support multiple production functions (from Quality operations...

About This Role The Executive Assistant (EA) to the Chief Quality Officer plays a pivotal role in ensuring the seamless operation of the leadership office. As a key member of the team, you will manage complex calendars, coordinate high-impact engagements, and foster proactive communication across the organization. This role requires exceptional organizational skills, discretion, and the ability to operate independently in a fast-paced environment. You will collaborate closely with the Strategy & Operations Lead to align priorities, support leadership forums, and drive strategic initiatives. Additionally, you will act as a central point of contact for stakeholders across Biogen and externally,...

About This Role As a Sr. Associate II, Quality Assurance (Quality Systems), you will play a pivotal role in ensuring the compliance and efficiency of quality systems at our Biogen RTP facility. Your expertise will be vital in overseeing Quality Control compliance of exceptions and CAPAs, contributing to the issuance and management of GMP documents, and supporting internal operations. This role is integral to maintaining GMP standards and will involve collaborating across functions to drive continuous improvement and global alignment. You'll be responsible for authoring key site reports and facilitating critical meetings and governance boards. Your contributions will support regulatory...

Responsibilities 1. Strategy and Roadmap Development Define and continuously refine a CMC RA Digital Enablement roadmap aligned to organizational priorities and enterprise platforms. Prioritize use cases across submission acceleration, regulatory intelligence, authoring automation, and knowledge reuse. Translate CMC-specific digital needs into business cases for enterprise-level investments. Lead the business case development and ROI analysis for new digital investments, effectively communicating trade-offs between speed, cost, and scope to leadership. 2. Program Delivery and Vendor Coordination In partnership with IT, identify, evaluate, and create strategic partnerships with established and emerging technology providers to bring cutting-edge solutions and expertise into the organization In...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of assigned product(s) in various stages of drug development, which may include products of medium complexity and updates to TLP, CCDS, USPI and EU SmPC. You...

We are searching for the best talent for a Manager, Health Care Compliance to be based in Santa Clara, CA; New Brunswick, NJ; Raritan, NJ; West Chester, PA; Irvine, CA; or Danvers, MA. Purpose The Healthcare Compliance Manager will support Shockwave Medical, and play a key role in ensuring the Company meets statutory and regulatory requirements relating the health care fraud and abuse; as well as advertising and promotion laws governing commercial and scientific activities. This role will also support Shockwave’s health care compliance integration activities. You will be responsible for Partner with business and functional stakeholders and provide compliance...

We are searching for the best talent for Manager, Regulatory Affairs to support the Power Tools team within our Orthopaedics group. The preferred location for this role is Palm Beach Gardens, FL but candidates in Zuchwil or Oberdorf, CH will also be considered . This role will work a Flex/Hybrid schedule with 3 days per week on-site There is NO remote option . 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...

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 is currently seeking a Facilities Management Compliance Lead to join our team. The role will be located in Wilson , North Carolina . As the FM Compliance Lead you will be responsible for the compliance and...

We are searching for the best talent for a Principal Regulatory Compliance Specialist to be located in Danvers, MA. 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 The position of the Principal Regulatory Compliance Specialist is responsible for establishing and maintaining robust Compliance Programs at the designated Abiomed sites in order to ensure compliance to local, national and international regulatory requirements, company policies and procedures and J&J corporate requirements. The Principal...

Careers that Change Lives Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. Agility and responsiveness are critical to our success with remote monitoring, wearables, robotics, AR/VR, telemedicine, and more. Experience what it’s like to work at a company with an exciting product pipeline entire of patented inventions driving innovation in the healthcare space. The Ear, Nose, and Throat Operating Unit is a global leader and trusted partner for innovative ENT solutions that improve patient access, outcomes, and customer satisfaction. We partner with the ENT community to understand the needs of customers...

Careers that Change Lives Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. Agility and responsiveness are critical to our success with remote monitoring, wearables, robotics, AR/VR, telemedicine, and more. Experience what it’s like to work at a company with an exciting product pipeline of patented inventions driving innovation in the healthcare space. The Ear, Nose, and Throat Operating Unit is a global leader and trusted partner for innovative ENT solutions that improve patient access, outcomes, and customer satisfaction. We partner with the ENT community to understand the needs of customers and...

The Diabetes Group The Sr Program Manager - Development Process & Compliance will be responsible to lead/co-lead the Product Development processes encompassing design controls. Responsibilities may include the following and other duties may be assigned Leads or leverages cross functional teams to evaluate, develop and manage projects for existing product development processes and ongoing PDP lifecycle process management. Identifies and leads PDP improvement initiatives including stakeholder management, driving vision to implementation and training strategies. Oversees and manages the operational aspects of ongoing projects and serves as liaison to project teams to represent the PDP process. Manages the development and...

In this exciting role as a Compliance Manager, you will have responsibility for leading the compliance audit program for the Medtronic Diabetes business. The Compliance Manager is responsible for managing the compliance audit program, for internal, external and supplier audits at the Diabetes sites. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash...

This position works out of our Alameda, CA office and is responsible for ensuring that Abbott and Lingo product software and computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements. This is an individual contributor position which may have responsibilities to monitor and direct the work of contractors/temporaries. What You’ll Work On Participates as a member of the project team for Lingo products that incorporate software/firmware into their system. Completes SWQA tasks in accordance with current Quality System Requirements. Works independently with objectives given by SWQA Manager....

Job Title Quality Engineer This position works out of our Houston, TX location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. THIS IS AN ONSITE DAILY REQUIRED POSITION. What You’ll Work On This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within manufacturing, or system/services support. MAIN RESPONSIBILITIES Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements Lead in the implementation of assurances, process...

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, Global Regulatory Affairs, Global...

Purpose The Quality Systems Specialist is responsible for providing quality assurance support for some or all of the following manufacturing processes pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations. Responsibilities Assist with proper integration and support of quality regulations drug, biologics, device and/or combination products. Assist project teams in planning, preparation, review and approval...

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

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

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

Johnson & Johnson is hiring for a Manager, Regulatory Affairs – Shockwave Medica l to join our team. The position is FULLY REMOTE and can sit anywhere in the US . Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local...

Johnson & Johnson is recruiting for a Senior Director, BWI Quality & Compliance to support our Cardiac Electrophysiology business. The role is based in Irvine, CA. POSITION SUMMARY Head of Quality, responsible for ensuring effective implementation of BWI Quality Management System. RESPONSIBILITIES In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position Leads BWI Worldwide Quality functions, setting the strategies and goals in accordance with applicable regulatory requirements. Johnson and Johnson Enterprise, Medical Device and CSS policies and goals. Product Quality – Oversees directly and indirectly organization of Quality professionals,...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. This is a key role on the Shop Floor Quality Assurance team. As Manager, Shop Floor Quality Assurance, Cell Therapy ,...

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our team is looking for a Customs and Trade Compliance Analyst to be based out of our office in Irving, TX or North Chicago, IL. This new team member will provide technical and analytical support for customs and trade compliance matters at the site/division level, ensuring compliance with all relevant customs...

This position works out of either Abbott Park, Illinois or Willis Tower, Chicago, IL location within the Global HR Services Team as a HR Data Privacy and Compliance Analyst. This position offers high visibility to senior HR leadership and provides a strong foundation for future growth into broader Security, Compliance, or HR roles. The HR Data Privacy and Compliance Analyst will collaborate closely with HR colleagues, affiliate teams, and technical partners to drive the strategy, execution, and continuous improvement of data privacy and compliance practices across the HR technology ecosystem. This role plays a critical part in safeguarding employee data...

This position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. We are seeking a passionate Manager in Quality Engineering to lead and develop an engineering team responsible for operations quality, design changes, transfer projects, and post-market surveillance within assigned product areas. The manager will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited...

The Associate Director, CMC Regulatory Affairs, Biologics executes multi-product global regulatory CMC strategies for investigational and marketed products, with a focus on biologics. This role leads the preparation and filing of regulatory CMC submissions and manages the interactions with Health Authorities for CMC topics. This role also provides regulatory guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial products. This role may supervise or mentor other regulatory staff. Key Duties and Responsibilities Leads the preparation and review of CMC sections of regulatory submissions, as well as the interactions...

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 Quality Control Engineer Co-Op to be in Gurabo, PR . The typical Co-op term is from January, 2026 to January, 2027 Full time requirement (40 hours per week) Purpose The incumbent...

OBJECTIVES (Briefly summarise the overall purpose of the position. Objectives should be written in 3 – 4 bulleted statements). Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorisation activities in the commercial business units and affiliates. Contributes to and implements the engagement strategy among R&D, Business Units and affiliates and Quality to ensure a global framework and robust quality systems are in place for the transition of R&D pipeline to the commercial space. Drives a fit-for-use global Quality framework that elevates the capabilities in the business units and the affiliate and enables them to deliver their clinical...