Quality & Regulatory Jobs in Pharma & Biotech

Use Your Power for Purpose This position will oversee the Quality Control Laboratory in Rochester, MI. The Rochester Quality Control Laboratory performs Assay, Viscosity, Breakloose & Extrusion, Sterility, Gas chromatography, pH, LOD, Bacterial Endotoxin, Karl Fischer, and multiple other analytical technologies used to determine quality attributes for Rochester manufactured Drug Products. The selected candidate will lead the laboratory to meet defined quality standards and QO objectives. Ensures cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes. Fosters teamwork and colleague development, as well as change management, within the laboratory and department. Provides guidance and...

As a Senior Quality Systems - CAPA Specialist, you will have responsibility for coordinating the Medtronic Energy and Component Center (MECC) Quality CAPA Portfolio. Coordination includes partnering with those team members to define, investigate, execute, and resolve product and quality systems issues to ensure they don’t recur. By supporting the Quality Function, you will provide critical compliance guidance and direction for CAPA impacting battery and component nonconformances, complaints, regulatory reporting, PHO, and FCA. Responsibilities will include additional Quality Management System project work as needed. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in...

The mission of Quality Assurance is to safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies. This position reports to the Director, Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies follow current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas...

The Laboratory Operations Quality Specialist- AVS provides quality oversight of the Airflow Visualization Studies at the West Point vaccine manufacturing site. The Specialist, with guidance from the Associate Director of Environmental Monitoring Site Support, ensures AVS are performed per the required schedule; meeting the necessary acceptance criteria. The individual will be responsible for scheduling, written documentation, video recording, and video editing of the studies. This position works closely with the vaccine manufacturing departments and Engineering/Maintenance to ensure timely completion of tasks with emphasis on right first time. The specialist will become knowledgeable in regulatory requirements and cGMPs to assure the...

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

Your skills could be critical in helping our teams accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other product and disease-related materials for assigned products. As the product expert, this individual helps to develop and implement regulatory strategies related to promotional and advertising campaigns for marketed products and development projects. Provides input into labeling strategies for investigational and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB). We are an innovative global healthcare company with one...

Sr Associate QA Plant Quality Assurance (PQA)- Night shift What you will do Let’s do this! Let’s change the world! In this vital role Amgen North Carolina (ANC) Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching,...

Johnson & Johnson is currently recruiting a Quality Engineer II - PMS may be based out of Warsaw, IN, Raynham, MA, or West Chester, PA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more...

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

The 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. Our Company's Research Lab's Quality Assurance department is seeking a co-op student who will work collaboratively in a team environment to help advance Quality throughout the drug development life cycle. Our Company's Research Lab's Quality Assurance department is comprised of various teams that maintain quality focus at each critical...

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

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 Core Lab team is looking for an Operations Quality Engineer out of our Irving, TX office. They will be responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. Heavy focus on the operation side, mostly with quality inspections. Responsibilities Responsible for...

Your skills could be critical in helping our teams accelerate progress. Our team is involved in developing regulatory product strategies for the Immunology and Inflammation therapeutic area, leading regulatory efforts in the development stage of drug products. The Regulatory Strategist 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. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career,...

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

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...

In this exciting role as Senior Engineering Director - Supplier Quality, you will have responsibility for leading a team of Supplier Quality Directors, Managers, and SQE’s located in the Orange County Campus, Tijuana Campus, Colorado Campus, and Tempe Manufacturing Site. You will develop long term strategic relationships and alliances with key internal and external stakeholders and communicate and conduct briefings with senior or executive leadership regarding ongoing operations and strategic initiatives. Your team will be accountable for changes to existing supplied products and processes, as well as oversight of performance and improvement activities. At Medtronic, we must work with a...

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...

The Regional Distribution Quality Specialist is responsible for ensuring the quality of distribution operations across the Americas, focusing on warehousing, order fulfillment, product returns, and value-added services such as labeling, boxing and recharging. This role will provide quality support and oversight to ensure compliance with internal and external regulations, standards, and guidelines, specifically ISO 13485, and 21 CFR 820, across multiple 3PL distribution centers in the Americas in support of Medtronic Minimed. 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...

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

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Associate Quality Assurance Engineer, Supplier Quality will provide support to the Supplier Quality Engineering team. The position may lead or assist in developing and documenting new procedures for Supplier Quality Engineering. This position will operate independently with...

Development Quality Engineer 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 Development Quality Engineer, you’ll assure new or modified products conform to requirements and establish compliance with the quality system. This position is 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 position will support the...

The Design Quality Engineer position is one of development, improvement, and innovation, through cross functional collaboration. If you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you. You will be tasked to provide quality engineering support in design and development of medical device products across the Acute Care and Monitoring [ACM] portfolio of products. Facilitate the application of design controls, Risk Management and Change Control processes in the evaluation and release of product changes. As our Design Quality engineer, your Key responsibilities will include Critically review new...

Purpose The Quality Associate supports the Quality Function that they are responsible for within Operations. This could include Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance. Expectations that the Quality Associate will maintain high quality levels on all aspects of their job while achieving high levels of efficiency. Responsibilities Responsible for various aspects of quality assurance and quality control related to their functional area. Ensures that product within the plant is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements. Support troubleshooting and resolution of...

Purpose Safety Compliance drives excellence in global pharmacovigilance (PV) quality standards and policy, through the establishment, maintenance and monitoring of the PV quality management system; providing the framework for the Global Patient Safety (GPS) organization to enable operational excellence in compliance with legal requirements worldwide and pragmatic risk-taking in PV policy decisions and process design. The Safety Compliance Analyst is responsible to gather and analyse data to support robust decision making and evidence the state of compliance of the AbbVie PV system. This position will support the Safety Compliance Oversight and Improvement team leader in the execution of PV system...

We are seeking a strategic and experienced Senior Manager, Quality Systems to lead our global internal audit and compliance programs across multiple divisions and global sites. This role is pivotal in ensuring consistent adherence to external laws, regulations, guidance, and standards (LRGs Local and Reginal Governments Standards), while driving continuous improvement in quality systems, regulatory compliance, and operational excellence. You will lead a team of professionals responsible for internal audits, investigations, audit execution, and quality system enhancements. This role is pivotal in mitigating risk, supporting external audits, and fostering a culture of compliance and performance across Abbott’s global operations. This...

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

Program Manager – Pleasanton, CA, Burlington, CA, or Atlanta, GA Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure (HF) division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in heart failure, allowing people to restore their health and get on with their lives. We are recruiting for a Program Manager- Global Quality to join our Heart Failure (HF) Quality Assurance Team working out of our locations in Pleasanton, CA, Burlington, MA or Atlanta, GA. This is a high growth business division working on Mechanical Circulatory Support...

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

Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical device, combination product, digital health and in-vitro diagnostic (IVD) products within the Sanofi portfolio of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance...

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. This position supports the execution of routine testing in the Quality Control Microbiology laboratory while strictly adhering to site work instructions, Federal Regulations, cGMP, and Sanofi Pasteur policies and procedures. This position requires the individual to perform route testing as scheduled to support production, method validation as well as the...

Quality Control Manager What you will do In this vital role you will be responsible for on-site management of Quality Control Bioanalytics team (Monday - Friday). Responsibilities include leading and supervision of staff, maintenance of the weekly lab schedule and prioritization of daily work tasks. Providing Quality oversight to ensure that processes are followed in accordance to current Good Manufacturing Practices (cGMP). The Manager will ensure that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations. Perform review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited...

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

Quality Control Associate I What you will do In this vital role you will complete and review analytical testing in our cGMP laboratory. The role will be on-site based out of Amgen Rhode Island and will work under the mentorship of the front line manager. The Bioanalytics team provides analytical expertise in testing in-process, release and stability samples. The laboratory employs a variety of test methodologies that uses sophisticated equipment including HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as Appearance, Color, Clarity, pH, Osmolality, Polysorbate testing. Responsibilities Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory...

About the role The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of processes and product outputs. This role involves defining and specifying activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's mission to provide better health and a brighter future. This role can be located in Cambridge, MA or Zurich, Switzerland and is Hybrid (not remote). R elocation Benefit is available to support your transition. How will you contribute Ensure compliance to Regulatory Intelligence Procedures...

Johnson & Johnson is currently recruiting for a Manager External Clinical Supply Quality! This position can be located in New Jersey, Pennsylvania or Beerse, Belgium. The Manager, External Clinical Supply Quality, role is responsible for the quality and compliance in the selection, qualification, monitoring and management for external suppliers used for the packaging, labeling, over-encapsulation, and distribution of Investigational Medicinal products. Additionally, this individual will support the coaching and development within the team of employees supporting these functions, as well as continuous improvement for proactive quality and/or business needs. Key Responsibilities This position will serve as a Quality contact...

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 dedicated to delivering a high-quality, reliable supply to customers and patients on time, every time. The Quality organization ensures all products meet regulatory and company standards through robust testing and continuous improvement. We are looking for talented and motivated students for a 6-month Quality Control Co-op, and will include one or more projects. This opportunity in our Quality organization can provide you with significant development and a chance to see...

The Manager, Quality Assurance - Distribution (US market), a member of the Global Product Distribution & Affiliates (GPD&A) group, supports distribution of Gilead products (including prescription samples) within the US market. This role acts as Designated Representative (DR) for Asegua Therapeutics LLC’s (Asegua), a wholly owned subsidiary of Gilead Sciences Inc, and works closely with the Director QA as well as with internal & external stakeholders, to ensure quality requirements are met and compliance to Good Distribution Practice (GDP) is adhered to for Gilead products, throughout the US distribution network to patients. Key Responsibilities Act as Designated Representative (DR), for...

Purpose Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports. Requires knowledge and technical expertise of Microbiology, regulatory requirements and Global TrackWise system. Responsibilities Responsible for microbiology lab investigations. Extensive knowledge of Global TrackWise System and lab procedures, processes and methods. Performs, coordinates and supports method validations and prepares final reports documenting the validation findings. Receives and interprets the results of bioburden, microbial limits, environmental monitoring, growth promotion testing and sterility testing. Investigates all out-of-limit conditions and with the direct support from the QC Lab Manager implement a corrective...

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

The Compliance Associate Director assists in implementing and further enhancing the anti-corruption/anti-bribery Compliance program. Reporting to the Executive Director Head of Global Compliance Program Strategy, Assurance and Management, the Compliance Associate Director will be responsible for executing compliance-related investigations and supporting the company’s global healthcare fraud and abuse assurance program and activities, including auditing and monitoring, both transactional and live. The Compliance Associate Director will serve as the initial point of contact for business colleagues for these activities, will support department initiatives globally and must have knowledge of the biotechnology/pharmaceutical industry, anti-bribery/anti-corruption laws, and experience executing compliance-related investigations as well...

The role will be accountable for QA operations in US, Canada & LATAM markets to ensure GMP & GDP compliance for Gilead products. This role will be directly responsible for developing QA strategies that strengthen & harmonize GDP compliance across the US, Canada & LATAM regions. The Senior Director QA will sit on the GPD&A leadership team, who are responsible for the management and operational development of strategy for Gilead Quality Distribution & QA Operations within each market Gilead supply, and the individual is expected to actively participate in, and support the goals of this Leadership team. The role also...

The Director Quality Assurance, US market, a member of the Global Product Distribution & Affiliates (GPD&A) group, is responsible for supporting distribution of Gilead products within the US market. The Director QA acts as Designated Representative (DR) for Gilead

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

Johnson & Johnson Health Care

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 Senior Specialist, External Manufacturing Quality Assurance is responsible for quality oversight of the Contract Manufacturing Organization (CMO) operations for Radiopharmaceutical products in accordance with business agreements, regulatory standards, and RayzeBio procedures. The scope includes clinical and commercial...

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 and Position Overview Lilly recently announced a $4.5 billion investment...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Join Medtronic as a Software Reliability Engineering Program Manager - Quality Core Team Member and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Join Medtronic as a Senior Software Quality Engineer and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to drive quality for design, development, and...

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...

Medtronic’s North Haven, CT facility is seeking a dedicated Supplier Quality Engineer II to join our dynamic team. This role serves as a backfill position, supporting daily operations and playing a pivotal part in managing Supplier Change Requests (SCRs). As a critical contributor to our quality plan KPIs for SCRs, the Supplier Quality Engineer II helps ensure uninterrupted production and protects our supply chain from line down impacts. If you’re passionate about driving quality and collaborating with suppliers to deliver world-class medical products, we encourage you to apply! Responsibilities may include the following and other duties may be assigned. Plans,...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. *This will sit out of our Independence, OH office* Join Medtronic as a Software Quality Engineer II and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and...

This role will be part of the Corrective and Preventive Action (CAPA) Specialists Team at the Cardiac Rhythm Management (CRM) operating unit. This team is responsible for CAPA process expertise, and assists CAPA Owners with compliance to CAPA requirements, guidance, and best practices. The Principle CAPA Specialist position is expected to be an expert in CAPA scoping, root cause analysis, action planning & execution, and techniques for verification of CAPA effectiveness. The CRM team develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of...

Sr. Design Quality Manager - RPE [Released Product Engineering]. Sr. Design Quality Manager for Released Product Engineering [RPE] within ACM OU. With responsibility for the management of all released product engineering changes across the ACM portfolio of products. The role involves the management of a global Design Quality engineering team focused on RPE product changes. Ensuring the ACM portfolio of products remain state-of-the-art and always available to our customers, as we qualify planned and forced product, packaging, labelling and process changes. In this role, you will be tasked with championing the application of industry leading standards in design controls, Risk...

Envision spending six months 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 AbbVie Co-Ops. As a 2026 Knowledge Management Quality Control Onboarding Co-Op, you will have the opportunity to support key training initiatives within the Quality Control Analysis (QCA) and Quality Control Management (QCM) departments. This position will involve developing Job-Specific Training Manuals (JSTMs), qualifying and re-qualifying QCA/QCM personnel, and coordinating training sessions to ensure compliance and skill advancement. Key Responsibilities Include Conduct training sessions for QCA/QCM personnel Develop...

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

Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies. As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our...

Job Title Quality Engineer This position works out of our Liberty, SC location. This is an onsite role . The Quality Engineer is involved in all aspects of the manufacturing operation from assessing equipment needs, to documenting installation, qualification, and ongoing validation of equipment and processes. The Quality Engineer is also expected to assist in the identification and resolution of quality related issues. 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. What You’ll Work On Implements Process Monitoring Systems by...

Summary The Senior Engineer, IT Computer System Validation, Cell Therapy Devens role will provide support to the Digital Plant team at the Devens Cell Therapy Facility (CTF) through managing the computerized system validation (CSV) activities / major projects and supporting deviations and change controls related to computerized systems. This position work closely with the Digital Plant (IT/Automation) subject matter experts and other key stakeholders, such as Manufacturing Science and Technology (MS&T), Quality Engineering (QE), and Manufacturing Operations. Major Duties & Job Responsibilities Gain a thorough understanding of computer systems deployed at Devens CTF. Act as CSV Subject Matter Expert (SME)...

Join Genentech in South San Francisco, CA as a Principal Healthcare Compliance Manager, Advisory! Seeking a highly experienced senior compliance professional for a strategic role with significant organizational impact. As a Principal Healthcare Compliance, Advisor you will serve as the primary consultant for multiple business units, advising on and developing policy, guidelines, and training for complex risk areas. This role holds full strategic responsibility for understanding business priorities and advising across the compliance ecosystem. You will proactively research evolving regulations, influence the development of long-range plans and overall objectives for Genentech, and represent the department on high-impact cross-functional committees. Decisions...

Ethicon Medtech is looking for the best talent for a Quality Engineer to be located in Cornelia, GA or Athens, GA . 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 Key Responsibilities Determine quality standards and ensure compliance with industry regulations. Develop and implement quality control processes to ensure flawless production. Collaborate with diverse teams to identify areas for improvement and implement effective solutions. Conduct thorough product testing and analysis...

Johnson & Johnson is hiring for a Principal Regulatory Affairs Specialist- Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Associate Quality Assurance Engineer will provide support to Operations for a variety of functions such as material receipt, production, process validation, facility qualification, and test method validation to determine the acceptability of material and the process in...

The AstraZeneca Mt. Vernon site was established in 1972 and is the flagship site delivering innovative, life changing oral solid medicines. At the site we formulate and pack OSD tablets and capsules for over 60+ markets. The Mt Vernon site is complex, the largest AZ production site in the US with over 700+ employees. We are located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana – the third largest city in the state. The Mt. Vernon site is both collaborative and Inclusive. We have several employee resource groups (ERGs) onsite that are aimed...

The Director, GDP Operational Quality is r esponsible to partner with Trade Operations to support the distribution of Vertex’s commercial product portfolio. The role is responsible for oversight of team activities, development of personnel and ensuring timely completion and quality of deliverables/goals within their remit. The role supports GDP quality operations for all distribution activities within the US; key stakeholders include Trade Operations, Vendor Quality Management & Quality Compliance. Key Duties and Responsibilities The responsibilities of this position may include, but are not limited to, the following Primary quality partner for Vertex US Trade Operations organization, providing quality input and...

In this exciting role as a Sr. Customer Quality Engineer, you will be a close partner of the Acute Care & Monitoring OEM customers. Our OEM customers or Strategic Alliance Partners, who are among the leading Medical Device companies in the world, integrate our products into their devices, and as such they require the highest standards of quality, reliability and safety. In this role, you will have the responsibility for managing a variety of quality activities related to the Acute Care & Monitoring Strategic Alliance customers, including working closely with the R&D group on integration acceptance testing and root cause...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as a Quality Technician III supporting the Cardiac Ablation Solutions organization, you will have responsibility for the inspection and testing of returned products as part of the complaint handling process. The Technician will be capable of supporting...

The Regulatory Data Steward plays a key role in ensuring the quality, integrity, and compliance of regulatory data within the Company’s Regulatory Information Management (RIM) ecosystem. This role combines hands-on data analysis and remediation with governance execution, supporting both operational data quality oversight and strategic regulatory compliance needs. The successful candidate will leverage strong data analysis skills, expertise in regulatory data standards, and knowledge of regulatory processes to safeguard master and transactional data. This position provides the opportunity to work across multiple functions and systems, integrating internal and external data assets into RIM platforms, while ensuring alignment with international regulations...

As an Associate Director, Global Regulatory Affairs, you will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the virology therapeutic area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submission Teams or other Regulatory Project Teams and represent Global Therapeutic Area Regulatory on cross-functional core and sub-teams. You will typically serve as a...

We anticipate the application window for this opening will close on - 26 Dec 2025 Position Quality Systems Manager for Medtronic, Inc. located in Northridge, CA. Provide expertise, guide, and ensure technical rigor in all aspects of Quality Engineering related to manufacturing Site Quality. Plan, coordinate, and execute Medical Device standards activities to ensure the safety and reliability of Medtronic Mini-Med products from concept to end of life. Support standards programs and systems, including both pre-market and post-market product support. Navigate various data analytical tools to deep dive into defect trending and reduce nonconformance. Navigate various standards activities to...

Our location in Sylmar, CA c urrent ly h as an opportun ity for a Senior Regulatory Affairs Specialist-China . As a Senior Regulatory Affairs Specialist , you are responsible for overseeing the approval process through China’s regul atory agency (NMPA) for Abbott’s Cardiac Rythm Management devices. This includes working with our counterparts located in China, acting as a liaison between China and US, and providing exper t knowl edge on regulatory matter s. What You’ll Work On As the Senior Speciali st in Regulat ory Affairs Sub-Function , considered as highly experienced and knowledgeable resource withi n th...

About This Role Are you passionate about driving compliance and operational excellence in a dynamic, global environment? We’re seeking a Regulatory Information Management (RIM) Manager to join our team and play a pivotal role in shaping the future of our regulatory systems. As our RIM Manager, you’ll be at the heart of our Regulatory Information Management Systems, partnering closely with business process owners and IT to ensure every system upgrade is evaluated and documented with precision. You’ll help maintain our systems and processes in a compliant state, supporting global users and empowering them to leverage regulatory systems effectively. You’ll serve...

This is an onsite position Monday through Friday business hours, with occasional weekend and off-shift support required About This Role The Biochemistry Manager will lead the Biochemistry function at our biologics drug substance manufacturing facility with a team of direct reports. This role is essential for overseeing release and stability testing, as well as supporting analytical method transfer and validation activities. What You’ll Do Lead and manage the site Biochemistry team, including hiring, training, and performance management Provide expert technical guidance and mentorship, supporting investigations, analytical method validation, and process improvements in QC Biochemistry Ensure compliance with Biogen policies, regulatory...

Principal Software Quality Engineer Medtronic ENT (Ear, Nose, and Throat) is an operating unit within Medtronic’s Neuroscience Portfolio. We focus on providing innovative solutions for ENT conditions, including surgical and therapeutic products designed to improve patient outcomes in ear, nose, and throat health. We are currently offering an excellent opportunity to join the ENT Quality team as a Principal Software Quality Engineer . This position is based onsite in Jacksonville, FL . Role Overview In this role, you will serve as an individual contributor responsible for ensuring the quality of software design and development for medical devices and related software...

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. Responsibilities may include the following and other duties may be assigned Partner with change management process development resources and draft new and revised documents necessary to support users in their effective, efficient, and compliant usage of Product Lifecycle Management (PLM) capabilities...

The Principal Compliance Audit Specialist – Software and Product Cybersecurity position focuses on auditing regulated medical device software, product cybersecurity, and risk management. We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers. Responsibilities may include the following and other duties may be assigned. Must have experience, subject matter expertise (SME), and technical knowledge working with regulated medical device software and product cybersecurity requirements. Remain informed on Regulatory requirements for...

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 Quality Engineer II to work onsite at Irvine, CA. The Quality Engineer II supervises, executes, and coordinates quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations...

Drives vision, strategic oversight, and operational delivery of GCP compliance and quality principles related to clinical trial execution. Ensures clinical studies are successfully implemented through a strong foundation of GCP Compliance, governing quality system documentation, and quality control of processes. Accountable for the end-to-end Clinical Trial Business Continuity process and escalation of business-critical decisions to Senior Leadership across R&D during times of crisis. Instills an Inspection Readiness culture enabling natural everyday compliance in support of successful inspection outcomes and on-time product approvals. Accelerates patient impact by delivering operational excellence to meet evolving business needs through collaborative partnerships, and a proactive,...

Drives vision, strategic oversight, and operational delivery of GCP compliance and quality principles related to clinical trial execution. Ensures clinical studies are successfully implemented through a strong foundation of GCP Compliance, governing quality system documentation, and quality control of processes. Accountable for the end-to-end Clinical Trial Business Continuity process and escalation of business-critical decisions to Senior Leadership across R&D during times of crisis. Instills an Inspection Readiness culture enabling natural everyday compliance in support of successful inspection outcomes and on-time product approvals. Accelerates patient impact by delivering operational excellence to meet evolving business needs through collaborative partnerships, and a proactive,...

Drives vision, strategic oversight, and operational delivery of GCP compliance and quality principles related to clinical trial execution. Ensures clinical studies are successfully implemented through a strong foundation of GCP Compliance, governing quality system documentation, and quality control of processes. Accountable for the end-to-end Clinical Trial Business Continuity process and escalation of business-critical decisions to Senior Leadership across R&D during times of crisis. Instills an Inspection Readiness culture enabling natural everyday compliance in support of successful inspection outcomes and on-time product approvals. Accelerates patient impact by delivering operational excellence to meet evolving business needs through collaborative partnerships, and a proactive,...

Drives vision, strategic oversight, and operational delivery of GCP compliance and quality principles related to clinical trial execution. Ensures clinical studies are successfully implemented through a strong foundation of GCP Compliance, governing quality system documentation, and quality control of processes. Accountable for the end-to-end Clinical Trial Business Continuity process and escalation of business-critical decisions to Senior Leadership across R&D during times of crisis. Instills an Inspection Readiness culture enabling natural everyday compliance in support of successful inspection outcomes and on-time product approvals. Accelerates patient impact by delivering operational excellence to meet evolving business needs through collaborative partnerships, and a proactive,...

Drives vision, strategic oversight, and operational delivery of GCP compliance and quality principles related to clinical trial execution. Ensures clinical studies are successfully implemented through a strong foundation of GCP Compliance, governing quality system documentation, and quality control of processes. Accountable for the end-to-end Clinical Trial Business Continuity process and escalation of business-critical decisions to Senior Leadership across R&D during times of crisis. Instills an Inspection Readiness culture enabling natural everyday compliance in support of successful inspection outcomes and on-time product approvals. Accelerates patient impact by delivering operational excellence to meet evolving business needs through collaborative partnerships, and a proactive,...

Senior Regulatory Writer, Remote “This position can be based remotely anywhere in the U.S. Please note that this role would not provide relocation as a result. The expectation of working hours and travel will be defined by the Hiring Manager. This position will require minimal travel” Purpose To write, review and/or manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide documentation related consultancy to other line functions. To coach/mentor and/or train less experienced writers. #LI-Remote Key Responsibilities 1. To author, review and manage high quality clinical and...

Quality Engineer I Abbott Molecular is hiring a Quality Engineer I at our Des Plaines, IL location within the Quality Assurance organization. This role will support manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. The Associate Quality Engineer will work with line supervisor, manufacturing engineer, and other team members, to address all opportunities found in the assigned manufacturing line and will be the primary quality representative for the area. WHAT YOU WILL DO Responsible for compliance with applicable Corporate and Divisional Policies and procedures....

Job Title Quality Inspector II This position will work out of our Minnetonka, MN 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. As the Quality Technician II, you will be responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support. What You’ll Work On Perform first article incoming inspection of purchased components and inspection of production operations, including documenting inspection and audit results. Perform final product...

to make a real difference in the lives of many About Lingo Abbott's rich history in developing cutting-edge health technologies is evolving with its new venture into b iowearables . The b iowearables segment is poised to represent the future of the organization, with the potential to generate over $1 billion in revenue within the next five years, supported by Abbott’s robust R&D and financial resources. At Lingo, we are committed to transforming health management with our cutting-edge biowearables that monitor glucose levels and other critical metabolic biomarkers. Our products integrate seamlessly with other health indicators such as sleep, exercise,...

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

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our...

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

Johnson & Johnson is recruiting for a Senior Specialist, QA Clinical Auditor to be located anywhere in the USA, preferably near a J&J office. Remote work options will be considered on a case-by-case basis and if approved by the Company. 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 In R&D...

The Executive Director, Cell Therapy Quality Compliance, is responsible for ensuring robust compliance with global regulations, BMS policies, and industry standards across all cell therapy activities. This leader oversees the implementation and continuous improvement of compliance programs, ensuring that all cell therapy operations—spanning development and commercial programs—meet or exceed regulatory and internal quality requirements. The Head of Cell Therapy Quality Compliance drives strategic compliance initiatives in partnership with cross-functional teams, including Process Development, Analytical Development, Global Manufacturing Science and Technology, Business Process Management, Internal and External Manufacturing, Regulatory Affairs, Brand Teams, Legal, Patient Safety, Medical Affairs, and Clinical Therapeutic Area...

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

Purpose 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....

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized...

The Associate Director of Compliance will report to the Large Molecule Regional Quality Lead, Americas. The responsibility of this position is across all Animal Health operating units and requires extensive collaboration with manufacturing sites, contractors, and suppliers. Primary Responsibilities Provide Subject Matter Expertise to ensure our company’s manufacturing sites adhere to compliance standards established in 9CFR and enforced by USDA-APHIS-CVB Inspection and Compliance (IC), and Policy, Licensing and Evaluation (PEL). Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements for facility design, auditing, quality systems and ensure team and company adherence to these documents. Develop a...

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

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...

About the role Join Takeda as a Senior Manager, USBU Ethics & Compliance Learning & Engagement, where you'll champion ethical behavior and help mitigate risk through impactful learning, communications, and digital innovation. Reporting to the Ethics & Compliance (E&C) Learning & Engagement Head, US Business Unit (USBU), you'll collaborate across Global E&C teams and partner with business stakeholders to design engaging training, manage strategic communications, and lead key projects like SharePoint site development and training dashboards. This dynamic role blends creativity and technology—leveraging tools like Articulate 360, Vyond, and AI—to simplify processes and enhance compliance across the USBU organization. How...

About the role As Head of Global Quality Systems Operations, you will set the strategic direction and ensure consistent excellence in our global quality management systems. You’ll lead the continuous improvement and digital transformation of quality processes at Takeda, working collaboratively across business units and regions. Your leadership will support compliance, operational effectiveness, and the successful evolution of our Global Quality organization. How you will contribute Lead and continuously enhance Takeda’s global One Quality Management System and digital platforms, driving innovation and compliance with evolving regulatory standards. Develop and maintain strong governance and business process frameworks for key quality systems,...

About the role As Senior Validation Engineer, you will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. You will report to Head of Engineering Services. This is an on-site position, and you will be required to work all five days from the office. How you will contribute Be a Validation Engineering representative and technical subject matter expert (SME)...

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

This position works every day on site out of our Carlsbad, CA location in the Cardiometabolic Division in Abbott Rapid Diagnostics. 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. What You’ll Work On This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. In addition...

Medtronic is seeking detail oriented assemblers with quality inspection and documentation review experience to join our team in Billerica. This critical position requires a strong quality focus and attention to detail. SAP experience preferred. Schedule Monday - Friday, 200 pm - 1030 pm Compensation Base hourly rate $24/hr Quarterly Operations Incentive bonus PTO - 4 weeks / year Paid holidays - 10 / year 401(k) with up to 60% match Comprehensive benefits plan, including medical, dental, vision, and more Fully subsidized Bachelors degree programs paid up front! Paid family, medical, and parental leave Responsibilities may include the following and other...

Regulatory Affairs Analyst Main responsibilities Support the execution of Regulatory Strategy. Implement the regulatory strategy for assigned products by processing registrations, renewals, post-approval changes, and promotional materials to obtain required health authorizations for business units. Ensure Complete Regulatory Submissions. Guarantee submission of complete dossiers to local health authorities through effective preparation and review processes to obtain timely approvals. Maintain Global Data Systems. Register product-related information in global electronic systems (Veeva Vault RIM, Qualipso, 4M PromoMats, OnePack) to comply with Sanofi's global guidelines. Manage Documentation and Archives. Compile physical and electronic product dossier files by creating comprehensive backup documentation of all...

Johnson and Johnson is recruiting for a Senior Manager Quality Control Operations! This position can be based in Malvern or Spring House, PA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Are...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready...

Company Overview Job Responsibilities Responsible for the preparation of moderately complex regulatory submissions which require 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. Responsible for submitting moderately complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs for assigned territories. Responsible for preparation of the Company Core Data Sheets (CCDS) for assigned products and ensures that any updates to the CCDS and the Product Company Core...

Senior Manager, Global Regulatory Diagnostics Strategy for Oncology You will represent Pfizer as an approval liaison in the regulatory affairs team assisting with diagnostics regulatory tasks. You will play the critical role of providing regulatory strategic direction to teams overseeing clinical development of products and diagnostics. This will involve interacting with regulatory agencies and diagnostics partners, including negotiations to expedite regulatory approval of trials co-developing medicinal and diagnostic products. Through your expertise, you will be the diagnostic regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing, commercialization, research project teams and government...

Associate Specialist Quality The Associate Specialist Quality is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday. What You’ll Work On Responsible for implementing and maintaining the effectiveness of the Quality System. Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation. Assist in determining quality attributes and requirements. may provide...

Associate Specialist Quality The Associate Specialist Quality is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday. What You’ll Work On Responsible for implementing and maintaining the effectiveness of the Quality System. Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation. Assist in determining quality attributes and requirements. may provide...

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

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 vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. Your unique talents...

Job Purpose Responsible for the CMC regulatory activities in the commercial lifecycle management of GSK products. Key Responsibilities Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities. Responsible for CMC strategy development, with managerial support, for CMC submission documents to support marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards. Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of global CMC applications. Ensures all appropriate CMC...

This role offers an exciting opportunity to lead and deliver Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for vaccines. You will manage global CMC regulatory activities across development, registration, and lifecycle management. Collaboration is key, as you’ll work closely with cross-functional teams to ensure compliance and drive innovation. We value candidates who are proactive, detail-oriented, and skilled at navigating complex regulatory environments. This role is based in the US at one of these locations Rockville, MD, Upper Merion, PA or Durham, NC. 2-3 days on-site per week average presence is required. Responsibilities Develop and implement CMC regulatory strategies for vaccines,...

This position works out of our Irvine, CA location on our EP (Electrophysiology) Quality team. 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 policies, procedures and forms. May provide coaching and mentoring for technical team personnel. Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers...

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. Position Associate Director - Quality Engineer Position Type Full-time Location...

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. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was...

At Johnson & Johnson Innovative Medicine, we use heart, science and ingenuity to create transformational medicines to improve the health of humanity. Every day, we work to advance scientific research and commercial innovation, to deliver solutions that provide value to patients, physicians and healthcare systems around the world. With a diverse company culture, we celebrate the uniqueness of our employees and are committed to inclusion. We collaborate with the world for the health of everyone in it. Global Regulatory Affairs (GRA) is looking for a high energy, inventive, self-starter intern for its 2026 program. We offer an exciting immersive summer...

That’s what makes us Genentech, a member of the Roche Group! Product Development Regulatory (PDR) is a flexible, bold, and distinctive regulatory organization. We are accountable and responsible for providing the framework to effectively understand, assess and influence the rapidly evolving regulatory landscape. The opportunity As a Regulatory Intelligence Specialist you will be a key contributor to our regulatory strategy by proactively monitoring, analyzing, and interpreting the evolving global regulatory landscape across multiple therapeutic and disease areas. You will translate complex regulatory information—such as new health authority guidances, competitor activities, and emerging policy trends—into actionable insights for project teams. You...

Purpose This position leads and maintains compliant Documentation Quality Systems (QS) according to AbbVie policies, procedures, and applicable government regulations by managing the documentation review board to process and update complaint plant procedures, Process Control Records, Specifications, Test Methods, and other GMP documentation. It also provides leadership to a team for the creation and/or update of material codes in the SAP inventory system and the electronic batch record recipes in POMs system. The Quality Systems and Third-Party Contractor (TPC) role also is the main QA point of contact with TPC to manage regulatory compliance and business continuity requests in a...

Kickstart Your Career at Vertex! Are you ready to make a real impact? At Vertex, our mission is to tackle serious diseases and to change lives, for the better, for the future. Our aim is to give you the skills, insights, and career guidance to be an important part of that future; to turn your potential into progression. As a Vertex intern or co-op, you’ll work on meaningful projects, collaborate with talented teams, and learn from industry leaders. We’re passionate about innovation, inclusion, and supporting your growth—inside and outside the lab. Why Vertex? Real Projects You’ll work on assignments that...

Kickstart Your Career at Vertex! Are you ready to make a real impact? At Vertex, our mission is to tackle serious diseases and to change lives, for the better, for the future. Our aim is to give you the skills, insights, and career guidance to be an important part of that future; to turn your potential into progression. As a Vertex intern or co-op, you’ll work on meaningful projects, collaborate with talented teams, and learn from industry leaders. We’re passionate about innovation, inclusion, and supporting your growth—inside and outside the lab. Why Vertex? Real Projects You’ll work on assignments that...

Do you thrive at the intersection of regulatory expertise and digital innovation? As the Strategic Initiative Lead, you will turn bold ideas into validated opportunities, transforming concepts into business-ready solutions that future-proof Sanofi’s Global Regulatory Affairs (GRA). Reporting to the Head of Engagement & Innovation, you will lead initiatives at the validation and acceleration stages of our innovation funnel, working closely with Innovation Leads, Business Process Owners, Capability Heads, and Digital partners. By applying your deep regulatory knowledge and proven leadership skills, you will guide high-risk, high-reward initiatives through uncertainty - framing the right problems, validating assumptions, and building 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 Global Quality Risk & Alert Management team (QRM-QAM team) is composed of two groups one managing proactive risks and the other managing Quality Alerts, Quality Product Alerts, Product Recall and Quality Defect Notification processes. Our mission is to develop and maintain mature End to End Global Quality Risk and...

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 Trade Compliance. Key Responsibilities Support major Global Trade Operation projects through data analysis (i.e. Operating Company initiatives, reports, databases, etc.) Provide recommendations to project teams bases on analysis Maintain databases used by Global Trade Operations and Global Trade Operation suppliers for various transactions Updates to metrics while working to improve and enhance processes with all available...

We are searching for the best talent for Manager, Regulatory Advertising & Promotion to join our Health Care Compliance organization. This position can be based in Horsham, PA, Titusville, NJ or New Brunswick, NJ. Please note that this position is not eligible for relocation and that onsite presence is required three days a week. Key Responsibilities Provide direction and oversight of regulatory advertising & promotion compliance activities for assigned products. Conduct regulatory promotional labeling and marketing compliance reviews in the R&D and commercial arenas to help ensure that activities and communications are consistent with product labeling, are adequately supported and...

Johnson & Johnson is currently recruiting for Quality Systems Document Management Associates! There are three current openings for this role and they will be located in Raritan, NJ. 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 The Quality Systems Document Management Associate will provide support for document...

Beam is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Promotion to progress advanced genetic medicines in a fast paced and dynamic biotech environment. The person will be responsible for leading all regulatory labeling activities for Beam’s hematology programs including creation of documents (e.g. CDS, USPI) and processes. Responsibilities Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles. Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications. Create regulatory labeling processes and associated SOPs,...

Position Senior Manager Validation Engineering Location Devens, MA Key Responsibilities Lead functions within the Validation Engineering group responsible for the qualification lifecycle of facility, utility and processing equipment systems. Leads functions responsible for installation, operational and performance qualification (I/O/PQ) of systems arising from projects and change controls. Leads the site Periodic Assessment and Requalification program by establishing procedures aligned with BMS directives and industry guidance. Ensures execution of program to predefined schedule. Establish validation project plans commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination...

Position Senior Manager Cleaning Validation Location Devens, MA Key Responsibilities Provide strategic oversight and management of the cleaning validation program, ensuring alignment with regulatory requirements and industry best practices. Develop, write, and execute cleaning validation protocols, reports, and risk assessments. Establish acceptance criteria and sampling plans for cleaning verification and validation. Delegate tasks and coordinate the execution of cleaning studies, ensuring timely and effective completion. Optimize and update cleaning validation strategies and procedures to reflect current industry standards and regulatory expectations. Perform swab and rinse sampling, cleanability, degradation and sampling recovery studies reviewing analytical results against acceptance limits. Support...

Patient Safety is seeking a dynamic and experienced individual to join the Patient Safety Strategic Operations team as an Associate Director, Patient Safety Medical Device Safety responsible for supporting activities to ensure ongoing safety oversight of Gilead’s medical devices and combination products throughout the product lifecycle. These activities include but are not limited to ensuring compliant global processes for vigilance/safety reporting, post-market surveillance system, trending of device complaints, risk management, and analysis of safety data sets covering Gilead medical device and combination product portfolio. This role will help drive strategies and ensure operational excellence through successful business partner collaboration. The...

Objective / Purpose The Head of Research Quality holds the highest leadership role within the Research Quality organization and serves as a key member of the R&D Quality leadership team. This executive is fully accountable for defining and executing the global strategic vision for Research Quality, overseeing a global team of experienced subject-matter experts dedicated to ensuring integrity, compliance, and ethical excellence in non-clinical research activities, studies, and processes supporting Takeda’s R&D pipeline. Through strategic leadership, impactful stakeholder engagement, and championing an enterprise-wide quality culture, the Head of Research Quality drives organizational success and reinforces Takeda’s commitment to industry-leading standards....

Job Title Staff Engineer, Customer Quality Analytics This position works out of our Sylmar, CA or Sunnyvale, CA location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. WHAT YOU'LL DO The Staff Engineer, Customer Quality Analytics is responsible for understanding and representing the customer experience for Cardiac Rhythm Management (CRM) products. The successful candidate will be a technically knowledgeable, customer facing experienced engineering or medical personnel who operates using facts and data and has...

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

Medical Director, AI Innovation and Validation, Global Patient Safety Location New York City, NY At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week . Our head office is purposely designed with collaboration in mind, providing...

Senior Development Quality Manager This position works out of our Menlo Park, CA location in the Structural Heart division. Structural Heart Business Mission Why We Exist! Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. 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...

Summary The primary objective of this position is to ensure the Bristol Myers Squibb US compliance with state regulations by preparing, submitting, and managing applications for various state licenses and permits. Must have the ability to stay update to date on regulatory changes, coordinate with state boards, keep and maintain organized records, and collaborate with internal departments such as legal, corporate governance and operations to support business expansion and ensure operational readiness. In this role, you will work collaboratively across functions and provide leadership and direction to multi-disciplinary teams including but not limited to third parties vendors engaged by BMS,...

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

Purpose The primary responsibility for the Quality Validation Specialis t is the Quality oversight and overall approval of validation and engineering change management activities. The Validation engineering department, will support the implementation of the Validation quality program, and will be expected to independently manage 5+ key projects simultaneously. Responsibilities Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility Executes tasks as required to implement the Validation Master Plan and...

Medtronic’s Cranial and Spinal Technologies (CST) Operating Unit is committed to transforming patient care through groundbreaking innovations in neurosurgery and spinal procedures. Our comprehensive portfolio includes spinal implants, robotics-assisted surgical solutions like the Mazor™ Robotic Guidance System, StealthStation™ surgical navigation, and biologics for bone healing, all designed to enhance surgical precision, efficiency, and patient outcomes. Beyond technology, we support surgeons through education, training, and clinical research, ensuring they have the tools and knowledge to achieve the best possible results. By continuously driving innovation and collaboration, Medtronic is redefining cranial and spinal care, improving lives worldwide. Join a diverse team of...

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. This position is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance and/or Drug Product Vaccine manufacturing. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across...

Your skills could be critical in helping our teams accelerate progress. The Director, Global Regulatory Affairs – Global Labeling Strategy is responsible for leading the development and implementation of global labeling strategy for assigned products, including those in early and late-stage development, life cycle management (LCM), and marketed portfolios. This role provides functional leadership and oversight for one or more therapeutic areas and may supervise or mentor Global Labeling Strategists. The Director plays an active role in shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including guidance on Phase 2 and Phase 3...

Your skills could be critical in helping our teams accelerate progress. As GRA CMC Lead within our GRA CMC & GRA Device Organization, you’ll drive global regulatory strategies for pharmaceutical and vaccine products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of drug approvals through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the opportunity to drive regulatory strategy for pharmaceutical products and vaccines across their lifecycle. Working at the intersection of science and compliance, you'll develop...

Purpose The Quality Systems Director serves as a leading subject matter expert and project manager for the continuous improvement of the AbbVie Quality System. As such, the QS Director must maintain current subject matter expertise in the latest developments in global pharmaceutical quality systems. In addition, the QS Director must be able to integrate and facilitate the formation of the Device Quality System both as a part of the AbbVie QS and as individual plant quality systems. The QS Director also serves as the Operations Coordinator of the Regulatory Intelligence Process. As such, they are responsible for the capture, dissemination...

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 Development Quality Engineer II, you’ll a ssure new or modified products conform to requirements and establish compliance with the quality system. This position is 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 position will support the new product...

Medtronic has declared its bold ambition to become the global healthcare technology leader. By doing so, we seek to reach more patients in more meaningful ways, more quickly. Are you looking to develop capabilities and competencies in Operational Excellence (OpEx) for a leader in the Medical Technology industry? As Sr. Director, Operational Excellence/Quality Lead, you will play a key role in enabling the enterprise evolution of the Medtronic Performance System (MPS). In this role, you will have the ability to own operational excellence processes, people, and results in driving change across our global Quality and Development organization. You will collaborate...

Responsible for Quality oversight of analytical methods and specifications used to test and release Acadia’s products. This position assists in establishing commercial analytical methods to support manufacturing, release, and stability testing conducted at Acadia's drug substance (DS) and drug product (DP) Contract Service Providers (CSPs). Responsible for the Quality oversight of CSPs performing GMP analytical testing and review of analytical method validations/transfers between laboratories. This position will be responsible for reviewing the quality of release testing and stability data for DS and DP. Coordinate efforts with CSPs to report and trend analytical test results in a timely manner. This position...

As a QA & Compliance Intern at AbbVie, you will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical and medical device industry. You will support the R&D Quality Assurance & Compliance team, which develops, implements, and continually improves the AbbVie Quality System in R&D. The team ensures that clinical research and operations consistently meet regulatory requirements, internal standards, and ethical guidelines, thereby protecting patient safety, upholding data integrity, and supporting the reliable development and approval of products. Key Responsibilities Independently review complex clinical trial and...

About the Role This application is for a 6-month student role from January - June 2026. Resume review begins in October 2025. Biogen’s Decision & Quality Analytics Innovation (DQAI) team is part of the Research Development & Medical (RDM) organization. The vision of the DQAI team is to drive data-driven insights from trusted data, and our team mission is to maximize the quality, efficiency and application of analytics across RDM Portfolio and Quality Management Systems through improved data and metrics management, optimization opportunities, identification of compliance risk, and enhanced business analytics application. Specifically, the DQAI team has four major focus...

The Senior Design Quality – Electronic Engineer position, is one of development, improvement and innovation. If you pride yourself on your problem-solving skills and a meticulous attention to detail this may be the role for you. You will be tasked to provide quality engineering support in the design and development of electronic medical device products. Facilitate the application of Design Controls, Risk Management and Change Control processes in the evaluation and implementation of changes to released products. Responsibilities may include the following and other duties may be assigned. Previous experience in Electronic PCB design and development. Preferably with a formal...

About the role The Supplier Quality Management Senior Analyst is responsible for identifying, coaching, and managing suppliers to ensure they meet Takeda’s quality standards and policies. This role supports strong supplier performance and compliance, contributing to Takeda’s mission of better health and a brighter future. As a Senior Analyst, you’ll address moderately scoped challenges using sound judgment within defined procedures and policies. You’ll apply industry practices and general knowledge to keep projects on track, primarily collaborating internally with subordinates and supervisors, with minimal external interaction. How you will contribute Execute global supplier and material/product management activities for locally assigned suppliers,...

As a QA & Compliance Intern at AbbVie, you will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical and medical device industry. You will support the R&D Quality Assurance & Compliance team, which develops, implements, and continually improves the AbbVie Quality System in R&D. The team ensures that clinical research and operations consistently meet regulatory requirements, internal standards, and ethical guidelines, thereby protecting patient safety, upholding data integrity, and supporting the reliable development and approval of products. Key Responsibilities Supporting the Quality Assurance & Compliance...

We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in Pleasanton, CA. This team member will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions as well as assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation. What You’ll Work On Develops worldwide strategies for regulatory...

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

responsibility for providing risk management expertise and best practices for released products and post-market activities within the Advanced Surgical Technologies organization. This includes evaluating product issues to ensure patient, user and security risk are assessed, and acting as the Quality Engineer Risk Management file owner for the CSI capital hardware and disposable products. Responsibilities may include the following and other duties may be assigned. · Serves as Subject Matter Expert for Risk Management across the Post-Market space for their assigned product families · Accountable for and owns the Risk Management Files for assigned product families · Maintains Risk Management Files...

GSK is currently looking for a Quality System & Data Associate Director to join our team in Rockville, MD. The Quality System & Data Associate Director provides leadership to a team of Quality professionals and is critical in overseeing data integrity and governance, document control, training compliance, Quality Management System (QMS) deployment, as well as defining and driving the site Quality Improvement Plan. The role also includes responsibility for driving GPS for Quality, Quality Culture and embedding Digital Strategy into the Quality organization. The Quality System & Data Associate Director reports to the Site Quality Director and is part of...

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 Quality Engineering Intern to be in Palm Beach Gardens, FL. Internship typical term is 10-12 weeks May to August, 2026 Full time requirement (40 hours per week) Purpose Our rapidly growing Velys Robotics and Power Tools Operation is in need of a Quality Engineering Intern who provides overall quality assurance support of on-site manufacturing...