Quality & Regulatory Jobs in Pharma & Biotech

Takeda is committed to innovation, efficiency, and continuous improvement. We believe in empowering our team members with the tools, skills, and resources they need to excel. As part of our Global Regulatory Affairs (GRA) Operations team, you will collaborate with stakeholders across Research & Development departments to deliver projects that drive meaningful results for both our personnel and our patients. Embark on a transformative journey where your curiosity meets innovation, and your ambition catalyzes organizational growth. As the business landscape continues to evolve, the ability to adapt and enhance processes through intelligent technology becomes paramount. We are searching for forward-thinking...

The Global Regulatory Affairs, Chemistry, Manufacturing, and Controls (GRA CMC) team resides within Takeda’s R&D organization. We are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing our R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. In an ever-changing and increasingly complex regulatory environment, we partner to develop and execute innovative CMC regulatory strategies to provide high-quality medicines and technologies to patients throughout the product lifecycle. This internship will allow the intern to learn about various...

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

Employer Vertex Pharmaceuticals Incorporated JOB TITLE Operational Area Quality Manager LOCATION 50 Northern Ave., Boston, Massachusetts, 02210 OPENINGS 1 DUTIES Responsible for generating performance metrics and identifying trends. Provide QA support of change controls, investigations, CAPA’s and effectiveness checks. Lead meetings as necessary and collaborate with customer groups to ensure quality systems are monitored and established metrics are met. Participates in compliance walkthroughs of the site and help to drive the closure of any observations. Responsible for identifying risks and communicating gaps for process/systems. Participate in continuous improvement of department processes and ensure the team continues to...

Sr. Manager, Regulatory Information Management About This Role Are you passionate about regulatory systems and business process excellence? As the RIM Senior Manager, you’ll be at the heart of our global Regulatory Information Management team. You’ll partner with business process owners and IT to ensure our RIM systems are accurately evaluated, documented, and maintained in a compliant state. This role is pivotal in enabling seamless business systems operations, supporting global users daily, and driving the success of our regulatory ecosystem. You’ll report to senior leadership and play a key role in shaping the future of regulatory information management within our...

About the role As a Quality Control Analyst, you will execute and review routine in-process, drug substance, and stability test methods. You will maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal) and conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability. You will own and author quality system events (i.e., laboratory investigations, deviations, CAPA's and change controls). How you will contribute Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and...

Quality Excellence Manager This position works out of our Sturgis, MI location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. For over 70 years, Abbott’s Sturgis, Mich. , has been impacting its community while producing products that provide essential nutrition to millions of families...

As a Senior Quality Systems Specialist , you will play a critical role in ensuring compliance with global regulatory requirements while helping to continuously improve our quality system to support innovation and patient safety. This is your opportunity to apply your quality systems expertise in a collaborative environment where your work truly matters. As a Senior Quality Systems Specialist, you will Lead and support Quality System processes , such as CAPA (Corrective and Preventive Action), Internal Audits, Management Review, and Document Control. Serve as a subject matter expert (SME) for one or more Quality System elements in compliance with FDA...

Quality Assurance Specialist Department. Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The Quality Assurance Specialist provides Quality support to both laboratory and manufacturing operations. The successful candidate will have the opportunity to apply their enthusiasm and skills as a...

Quality Assurance Associate Specialist Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The Quality Assurance Associate Specialist provides Quality support to manufacturing operations. The successful candidate will have the opportunity to apply their enthusiasm and skills as a member of...

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. We lead clinical teams to implement quality focused best practices in daily study management so that it becomes a reflexive action. We support the team’s ability to see how individual actions contribute to the collective goal of drug or vaccine registration to fulfil patient's needs, through successful pre-approval GCP inspection About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the...

Oversight of and participation in the development and execution of Computerized System Validation Life-Cycle documents / protocols, including but not limited to Validation Compliance Assessments, Validation Plans, Qualification Protocols, User Acceptance Tests, Change Controls, Periodic Validation Reviews, Audits, and Corrective Actions for audit findings for automated systems at the Marietta, R&D, Clinical Drug product site. Ensure both technical and procedural content of computerized system validation deliverables reflect current GSK Policy and procedures, government regulations, and industry practices. Coordination of validation activities with internal business partners / key stakeholders in a manner that satisfies procedural and operational requirements. Supervision, management, and...

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, Atlanta, GA, or Orlando, FL. This is a high growth business division working on Mechanical Circulatory Support and Pulmonary Pressure Measurement Systems. You will be responsible...

Johnson & Johnson is hiring for a Supplier Quality Engineer II – Shockwave Medica l to join our team located in Santa Clara, CA. 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...

We are searching for the best talent for Supply Chain Quality Director, Velys Enabling Tech. Work should be onsite in our state-of-the-art Palm Beach Gardens, FL Capital Equipment campus. Considerations for Hybrid from this site can be given for the right candidate. About Depuy Synthes Fueled by innovation at the intersection of biology and technology, we are developing the next generation of smarter, less invasive, more personalized treatments. Are you enthusiastic about improving and expanding the possibilities of Orthopaedics? Ready to join a team that is reimagining how we heal? Our Orthopaedics teams help keep more than six million people...

Johnson & Johnson is currently seeking a Quality Engineering Team Lead to join our team in Raynham, MA. Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of...

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

OBJECTIVES/PURPOSE Provides governance and oversight to all GxP Engineering and associated Equipment validation activities including Facility Engineering standards, Maintenance and Calibration processes, Commissioning, Installation, Operational, and Process Qualifications at Takeda to ensure compliance with GxP regulatory and quality standards while maintaining the integrity of data Oversees Business Processes and partners with Business Process Owners for applicable Validation activities to ensure consistency of approach across the network, including validation site master plans Ensures consistent use of applicable North Star systems to capture engineering and associated validation activities, such as installation and operational qualifications (IQ/OQ), Process qualifications (PQ) and...

You will oversee and manage initiatives within the IVD Regulatory Center of Excellence (COE), supporting oncology regulatory strategy programs across the drug development lifecycle. You’ll collaborate with cross-functional teams and external partners to drive high-quality IVD co-development program timelines, dashboards, and tools, enabling accurate reporting and decision-making. Your expertise will help resolve project issues, guide operational teams, and facilitate agreements across the enterprise. How You Will Contribute Oversee a global portfolio of IVD regulatory projects, ensuring timely initiation and execution of cross-functional study start-up activities. Plan and schedule project timelines and milestones using appropriate tools prior to study start-up. Forecast...

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. The Third-Party Quality team delivers strategic leadership and comprehensive oversight for Third Party Quality compliance across the MA BioCampus. Our focus is on ensuring excellence in quality standards and regulatory adherence in all external partnerships. The Third-Party Management Specialist is responsible for overseeing Third Party Quality for the MA BioCampus. This role is crucial in maintaining high-quality standards and ensuring compliance in our relationships with external partners. About Sanofi We’re an...

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

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

The Senior Specialist, Quality Assurance Lot Disposition (QALD) is a full-time position at the Bristol Myers Squibb (BMS) Bothell, WA Cell Therapy manufacturing site. The primary focus for this role is to ensure final drug products and incoming raw materials are released to market following all internal procedures and cGMP requirements. This position reports directly to the Senior Manager of Quality Assurance – Lot Disposition. Work Shift 4 x 10hrs / Day. Weekend and holiday work is required. Sat-Mon and Wed 8am -6pm Duties / Responsibilities Conduct routine lot disposition activities for finished drug products and incoming raw materials by...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation...

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 Quality Systems & Compliance Data Analytics Lead role provides critical...

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...

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

The Clinical Process Compliance Associate is an independent contributor who assists the Quality Control, Compliance, and/or Metrics team with the oversight of clinical trial activities based on the standards required to ensure adherence to GCP and AbbVie procedures. They are aware of both internal and external business environment requirements and escalate issues to management and develops scenarios for issue resolution. Responsibilities Responsible for compliance with applicable Corporate and Divisional policies and procedures. Assists in the completion of activities regarding quality control, compliance, investigational product release for clinical studies and/or data collection; including working with functional areas to ensure assigned activities...

The Clinical Process Compliance Associate is an independent contributor who assists the Quality Control, Compliance, and/or Metrics team with the oversight of clinical trial activities based on the standards required to ensure adherence to GCP and AbbVie procedures. They are aware of both internal and external business environment requirements and escalate issues to management and develops scenarios for issue resolution. Responsibilities Responsible for compliance with applicable Corporate and Divisional policies and procedures. Assists in the completion of activities regarding quality control, compliance, investigational product release for clinical studies and/or data collection; including working with functional areas to ensure assigned activities...

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Senior Director — Biologics/Small Molecules Microbiology Quality Control Foster City, CA Key Responsibilities The QC Microbiology Senior Director is vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control. This...

The Regulatory Data Governance Lead will ensure Regulatory information and data standards are aligned with Takeda’s strategic business requirements — including Master Data Management (MDM), Regulatory strategy, Industry standards, and evolving Health Authority (HA) expectations. In addition to supporting ongoing governance and data quality initiatives, this role will play a critical coordination role in Mergers & Acquisitions (M&A) activities , ensuring that data from acquired entities, products, and systems are properly assessed, migrated, and governed within Takeda’s Regulatory Information Management (RIM) ecosystem. The ideal candidate is a strong collaborator with an analytical mindset, experienced in metadata and data catalog management,...

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 is located in Cambridge, MA and it is Hybrid (not remote). R elocation Benefit is available to support your transition. How will you contribute Ensure compliance to Regulatory Intelligence Procedures by executing the...

Compliance Senior Manager, U.S. Rare Disease What you will do Let’s do this! Let’s change the world! The Senior Manager, Rare Disease Compliance, will serve as one of the compliance business partners for the Amgen Rare Disease Business Unit (RDBU), serving on a team that works closely with that organization’s leadership to uphold the reputation of Amgen and drive ethical solutions for the patients it serves. As a member of Amgen’s Worldwide Compliance & Business Ethics organization, the Senior Manager, Rare Disease Compliance, will work with various cross-functional organizations including Law, Regulatory, and Privacy to appropriately advise the business on...

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...

The Senior Quality Specialist ensures product/process quality system adherence and batch record review, completes quality checks and SAP transactions required to release product. The role performs process document audits for accuracy and completeness and works in a team environment to ensure timely review and documentation is Right First Time. The successful candidate provides support to include oversight for adherence to cGMPs and is knowledgeable in federal and other regulatory agency requirements and other regulatory agency requirements and cGMPs to ensure that all areas are in compliance and will train on and gain competency in activities to ensure quality and compliance...

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

Sr. Supplier Quality Engineer Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our location in Temecula, CA , currently has an opportunity for a Senior Quality Engineer . This role will serve as liaison between internal Abbott third party manufacturers and Abbott Vascular. Ensures effective implementation of quality and compliance requirements between multiple quality systems and sites. THIS IS AN ON-SITE DAILY ROLE. WHAT YOU'LL DO Position Responsibilities Work...

Quality Systems Analyst II The Quality Systems Analyst II will be responsible for supporting trend escalations, ensuring that potential product or process issues are thoroughly assessed and effectively managed. This includes applying structured root cause analysis (RCA) methodologies such as 5 Whys, Fishbone diagrams, and 6M frameworks to identify underlying drivers, validate findings, and reach well-supported conclusions for investigations. 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 Support complaint investigation activities related to glucose meters, ensuring compliance with procedures...

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. 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. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering...

Job Title Associate Supplier Quality Engineer This position works out of our Sylmar, CA location. This is an onsite role . As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. What You’ll Work On Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements Assist in...

This position works out of our Plymouth, MN location in the Electrophysiology Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. The Supplier Quality Engineer II role will drive improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You’ll Work On Assess potential new suppliers...

Quality Engineer II This position works out of our St Paul, MN location for our Electrophysiology medical device business. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As a Quality Engineer, you’ll play a key role in ensuring product excellence by investigating software/hardware-related customer complaints. Your work will directly impact product reliability and customer satisfaction. You’ll collaborate closely within a small to medium-sized team and across departments to uncover root causes and drive improvements. What You’ll...

This position works out of our Plymouth, MN location in the Electrophysiology Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. The Supplier Quality Engineer I role will provide engineering support for receiving inspection processes and material non-conformances. Drives improvement and corrective action in the quality of components sourced from outside suppliers to eliminate recurrence of non-conformances. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You’ll Work On Maintains incoming...

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...

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...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead. Represents and...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead. Represents...

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

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. We are seeking a Director, Quality Site Lead located in Foster City, CA. Job Functions Primary Pharmaceutical Development and Manufacturing (PDM) Quality contact accountable for proactive quality oversight for assigned Strategic Gilead CXO partners/sites. Assure CXOs meet Gilead’s quality, regulatory and compliance standards, to ensure a sustainable delivery of quality products to patients. Key member of Business Review Meetings with CXO as Quality’s voice for the contract organizations’ oversight. Maybe member or backup member of Joint Steering Committee. Ensure contract...

The Senior Director of Cell Therapy Quality Automation Services will report to the Executive Director of Cell Therapy Global Product Quality and serve as a key leader within the GCTQ Organization. This role will lead a global team of quality professionals focused on ensuring the highest standards of cGMP compliance, product quality, and regulatory readiness as BMS automates Cell Therapy manufacturing, testing and release. The Senior Director will play an integral role in supporting the implementation of advanced manufacturing, testing and quality systems platforms—including the Automated Manufacturing System (AMS), Automated Quality Control (AQC) system, Gene Delivery Manufacturing/Testing, Quality Management Systems...

Job Title Quality Engineer This position works out of our Barceloneta location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. As the Quality Engineer, you’ll have to support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. What You’ll Do Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Identifies manufacturing process defects (scrap, nonconforming material, customer complaints), dispositions non-conforming material, leads identification of primary root causes for basic investigations,...

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 unite caring with discovery to 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. Lilly is currently constructing an advanced manufacturing facility for production of...

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

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for Associate Analyst, Quality Control CAR-T to be in Raritan, NJ. Purpose The QC Associate Analyst is responsible for conducting biochemical, microbiological, and/or general testing of final product samples submitted to the...

Purpose The Associate Director, Compliance is a key leader in the Risk & Compliance team responsible for strategically developing and implementing procurement policy and requirements. This role oversees procurement compliance, leading the deployment of changes in policy and requirements and collaborating with cross-functional teams to adapt policy. The role leads Compliance Managers, sets clear objectives, and cultivates a team environment that values strategic thinking innovative problem-solving, and AI-enabled compliance policy management. Responsibilities Develop and implement a risk-based compliance model integrating AI-driven monitoring and analytics along with procurement policy and requirements, to align with organizational objectives and industry best practices to...

The Senior Director, Regulatory CMC will lead and evolve Apellis’s global Chemistry, Manufacturing, and Controls (CMC) and Regulatory Device strategies to support the company’s innovative therapeutic pipeline and marketed products. This position is responsible for developing, executing, and maintaining high-impact CMC regulatory strategies across development and commercial stages, ensuring global compliance while driving innovation and operational efficiency.The role will oversee both Regulatory CMC and Regulatory Device functions, serving as a key cross-functional leader who leverages data-driven systems, AI-enabled document management, and digital regulatory tools to enhance submission quality, accelerate timelines, and ensure inspection readiness. The successful candidate will be a...

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

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

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

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

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

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 Johnson & Johnson Robotics and Digital Solutions (RAD) is recruiting for a Quality Engineering Spring 2026 Co-Op, located in Santa Clara, California 6-month Term (January-June) As a Co-op in the Quality Engineering organization, you will have the chance to Use innovative tools and take advantage of training courses offered on-site. Perform testing, experimentation, verification, and validation to support product design. Assist in developing laboratory...

Join us at Medtronic’s Boulder, Colorado facility - a dynamic hub for surgical innovations within our Medical Surgical portfolio. As a Senior Supplier Quality Engineer, you’ll play a pivotal role in advancing Medtronic’s mission to alleviate pain, restore health, and extend life for patients around the world. If you’re driven by challenge, energized by innovation, and passionate about making a real difference, this is your opportunity to be part of the next generation of life-changing medical technology. At Medtronic Boulder, your work will help shape the future of healthcare and positively impact patients’ lives every day. We invite you to...

Material Compliance Manager What you will do In this vital role you will manage the materials review process for assigned business units and/or products. The manager will represent material compliance in process discussions with sponsors and reviewers and maintains integrity of neutrality while managing needs of all MAC stakeholders. The manager contributes to Amgen’s compliance initiatives by ensuring that all required promotional materials have undergone MAC review. Responsibilities Leads new and ongoing MAC process improvement efforts Provides guidance and direction to MAC Cross Functional team members Anticipates process issues and provides solutions for special circumstance reviews due to product...

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

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

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

This position works out of our Abbott Vascular Plant in Barceloneta, Puerto Rico at the 2nd second shift Monday to Friday . The Supervisor Quality Control is responsible for the performance of the quality technicians and meeting daily production / operational / department demands. He/she will work with line supervisor, manufacturing engineer, quality engineer, and other team members, to address all opportunities found in the manufacturing lines and will the primary quality representative for the quarantine area. The individual performing this role will have to ensure proper management of resources while ensure quality and compliance of employees/equipment, promotion of safe...

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

This position works out of our Lake Forest IL facility. What You’ll Work On The function of the Quality Program Manager is to provide leadership, oversight, and project management covering Abbott's Quality System. This includes division / business support and quality expertise and consulting activities. MAIN RESPONSIBILITIES Provide leadership and direction for furthering the development of the Abbott-wide Inspection Readiness Program. Act as a strategic partner for ensuring that our business locations are effective in the full life cycle of a third party inspection (preparation, execution, and response). Provide direction and consultation for third-party inspections including the identification and review...

This role will represent the business on cross functional teams delivering several projects in Gilead’s Commercial Manufacturing Organization. In this role, the individual will be responsible for ensuring initiatives and projects meet the core business requirements and impacted business processes are updated for internal manufacturing and serialization & traceability. These global business processes are applicable or used by internal sites, business functions, Commercial Manufacturing Organizations (CMOs), third party logistics (3PLs) providers, and alliance partners. Responsibilities Supports business analysis for changes and new initiatives within the commercial manufacturing organization for internal manufacturing and global serialization & traceability enterprise systems Responsible for...

The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. This role offers the opportunity to apply and further develop regulatory and technical expertise in small molecule CMC development of peptides and sterile injectables . This individual prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global...

Quality Control Inspector II This position works out of our Westfield, IN location in the Structural Heart division. 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. The Quality Control Inspector II provides an independent, unbiased evaluation of materials or the work of others. The results of the Inspector's evaluation is documented and communicated to organizational stakeholders with an interest in the evaluation's outcome - typically, this is supplier development and/ or manufacturing. The Inspector's approval certifies the work or material meets Abbott's...

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

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Responsibility for daily operation of laboratory including coordination of testing and data review to meet due dates. Participates in continuous improvements, lean activities, kaizens and other process improvement initiatives. Performs Quality sampling,...

Careers That Change Lives In this exciting role as a Senior Quality Systems Manager, you will have responsibility for QMS Data Analytics, Data Reporting and managing multiple Digital based improvement initiatives within the Quality Transformation organization that will systematically evaluate and transform the capability of the Quality Management System (QMS) to better meet the needs of its stakeholders, both internal and external. Quality Data steward, supporting Data analysis and reporting methodologies Leading a team of Data analysts to support specific analysis where needed to perform advanced data analysis, dashboarding, and reporting in support of quality improvement goals ...

A career at Medtronic is like no other. We’re purposeful, committed, and driven by our Mission; alleviate pain, restore health, and extend life. The Quality Technician III is a seasoned quality professional with experience in quality and operations. This individual will be responsible for working directly with supplier quality engineering and receiving inspection associates to investigate product issues, to perform containment on potentially nonconforming product, and to document results in technical reports. In addition, aligning product acceptance activities to the associated patient impact. This is a 2nd shift role at the MECC location in Brooklyn Center, MN. Preferred schedule would...

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

Do you have expertise in, and passion for Patient Safety in Oncology or Haemato-Oncology ? Would you like to apply your expertise to provide medico-scientific and clinical strategic leadership in a company that follows the science and turns ideas into innovative life changing medicines? Then AstraZeneca might be the one for you! AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. W e a re more than one of the world’s leading pharmaceutical companies. Working with one of the broadest cell therapy...

Do you have expertise in, and passion for Patient Safety in Oncology ? Would you like to apply your expertise to provide medico-scientific and clinical strategic leadership in a company that follows the science and turns ideas into innovative life changing medicines? Then AstraZeneca might be the one for you! AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. W e a re more than one of the world’s leading pharmaceutical companies. Working with one of the broadest cell therapy pipelines in...

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 unites caring with discovery to create medicines that make life...

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of...

Cleaning Validation Engineer SME 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...

MSAT - Quality Engineer 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...

We anticipate the application window for this opening will close on - 30 Dec 2025 Position Sr. Regulatory Affairs Specialist for Covidien, LP (a Medtronic company) located in North Haven, CT. Responsible for developing strategies for worldwide product registration with global regulatory agencies to introduce Wound Management devices to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with the license maintenance including renewals, design/manufacturing change notifications, QMS audits, and Manufacturing site registrations. Provide Regulatory Affairs support for maintenance of Core Suture Portfolio including regulatory activities throughout the entire product lifecycle,...

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. We have an opening for a Sr. Quality Engineer at our Minnetonka, MN site within our Electrophysiology division. This position will provide Process/Quality Engineering support to manufacturing for commercially released product, helping to ensure delivery of highest quality product to the customer. What You’ll Work On Reduces and controls manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing...

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

Johnson & Johnson MedTech Orthopedics (a member of the Johnson & Johnson Family of Companies) is currently seeking a Quality Engineer II to join our outstanding team located in Warsaw, Indiana. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The Quality Engineer II position will apply leadership, interdependent partnering, and Quality Engineering expertise to ensure efficient and effective quality & compliance and continuous improvement in our end-to-end business with a...

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

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

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Our Team/Overview The GoGemba GMP Walkthrough Program team is responsible for ensuring compliance with Good Manufacturing Practices (GMP) across the organization through systematic walkthrough s. Our mission is to maintain high quality standards and drive continuous improvement in our manufacturing processes. We are an innovative global healthcare company with one...

Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. Assures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements. This position will support the Neuroscience therapeutic area. Responsibilities Responsible for a product(s) or products with multiple driver...

The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for BMS Jump site records management. Responsibilities include but are not limited to receiving and reconciliation of GMP records, management of scanning, archival and retention of GMP records. Key Responsibilities Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed. Assist with managing the Document Center Archive room Thorough Knowledge of Records Management, Scanning and organization functions Follow Policies, SOPs, and work instructions to support the document...

As a Senior IT Quality & Regulatory Assurance Manager , you will lead SQA for US-based programs (e.g., Digital, Complaint Management, Salesforce). As the Process Owner of the BTS Software Lifecycle, ensures the applicable regulatory requirements are incorporated, oversees the execution to those requirements, and monitors the effectivity with consideration to evolving technologies, platforms, and compliance. Partners with vendors to ensure reliable, compliant, and cost-effective SQA support is provided for operations and audit support, while scaling for programs and initiatives. Provides the US-based SQA leads with direction and resources to enable compliance and effective program delivery, support, and inspection readiness....

In this exciting role as a Customer Quality Engineering Manager, 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 small team of customer quality engineers who work on a variety of quality activities related to the Acute Care & Monitoring Strategic Alliance customers, including working closely with...

Position Overview Basic Functions & Responsibilities Reporting to the Executive Director, Clinical Supplies Quality (CSQ), the Director, Clinical Supplies Quality – West Point , leads the team responsible for operational management, capacity planning, scheduling, and execution of clinical supplies disposition activities supporting our company's clinical development programs. This role ensures the reliable availability, quality, and regulatory compliance of clinical supplies produced at West Point. The Director CSQ WP is a strong partner in cross-functional teams and drives operational excellence and continuous improvement with a strong focus on integration of digital solutions. Primary Activities This position will require an in-depth close...

Join Us in Shaping the Future of Animal Health Our company's Animal Health is investing $895 million in expanding our manufacturing and research & development facilities in De Soto, Kansas — the state’s largest economic development project to date. We are seeking a Quality Assurance (QA) Specialist to support the site expansion project and ensure quality systems and day-to-day quality activities are executed to meet USDA regulatory requirements and the compnay's Animal Health Quality Manual. The QA Specialist will execute, document, and help optimize quality processes during the build-out and qualification phases and support handover to operations. As a Specialist...

The USDA Compliance Subject Matter Expert (SME) – Associate Director, will report to the Animal Health Global Quality Compliance and Technical Lead. The responsibility of this position is across all Animal Health operating units; however, the position will focus on US Quality activities related to governance by the USDA. The role will require collaboration with manufacturing sites, contractors, and suppliers. Primary Responsibilities Provide Subject Mater 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...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Global Regulatory Affairs Diagnostics. This position is a hybrid role and can be located in Raritan, NJ or Spring House, PA. Remote work options may be considered...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to...

Innovative Medicine, Regulatory Compliance, Large Molecule/Advanced Therapies Leader COMPANY BACKGROUND& CULTURE Johnson & Johnson (J&J) is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the pharmaceutical, and medical technologies professional markets. J&J employs approximately 126,500 people worldwide, deployed in more than 250 operating companies in 60 countries. Johnson & Johnson, Innovative Medicine a leading pharmaceutical company under Johnson & Johnson, has established a strong presence in the field of biologics and large molecule therapies, particularly through its innovative advanced therapies portfolio. The company's contributions have significantly advanced...

Come join the orthopedics surgical robotics team at Johnson & Johnson! DePuy Synthes is a MedTech and Devices company within J&J. As part of our team, you will support product quality, engineering, and reliability, ensuring the implementation and sustained support of groundbreaking technology for medical devices and digital health solutions is safe, effective, and follows regulations, standards, and industry practices. Working closely with multi-functional teams you will review and assess product development results (e.g. user needs, design & development plans, requirements, design documentation, risk management file, and verification & validation artifacts) to ensure that they align with applicable procedures standards...

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

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....

This position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Senior Supplier Development Quality Engineer are responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Supplier Development Quality Engineers drive improvement and corrective action in the quality of components sourced from outside suppliers. This position contributes to the development, establishment and maintenance of...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU within our Global Regulatory Affairs organization, based remotely. Partners with the Global Regulatory Lead (GRL) on Global...

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

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead will support our growing Oncology Portfolio. You will be accountable for management of all assigned programs/products as the internal expert on US Codes, guidance, and industry standards pertaining to prescription medicine promotion. How you will contribute Serve...

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

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. Main Purpose and Objectives The Associate Director-Quality Assurance is responsible for...

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...

Location Lake County, IL (AbbVie Headquarters) and open to other AbbVie office locations in the US. Purpose Medical Device Safety Physician leads the safety oversight relevant to her/his assigned products to determine and advise the course of action necessary to meet the safety goals and objectives of specific products and projects. Works in close collaboration with cross-functional teams and counterparts in quality systems, regulatory affairs, medical writing, clinical development, clinical operations, manufacturing, epidemiology, marketing and other functional areas to identify, evaluate, and communicate safety issues. May contribute relevant clinical safety input to new product design teams as needed. The Medical...

Director Of Quality Control (Pharma) About This Role As a visible member of the RTP Pharma Site Leadership team as well as the Global Quality Control Leadership team, you will provide both strategic and operational leadership for the Pharma Site Quality Control (QC) Operations organization. In this pivotal role, you will oversee a team dedicated to ensuring the highest standards of quality through chemical, biochemical, and biological analysis (microbiology) of various stages of drug substance and drug product material manufactured in our Parenteral Filling, Oral Solid Dose (OSD), and Antisense Oligonucleotide operations at RTP Pharma. You will develop and manage...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Senior Manager, Quality Systems, Investigations and CAPA Process Owner is responsible for ownership and oversight of the Investigations and CAPA...

Purpose The function of Audit and Compliance Auditor is to performs comprehensive audits for compliance with US and foreign regulation requirements, providing constructive evaluation of quality related systems for AbbVie plants, affiliates, quality service areas and/or suppliers that provide materials, services, and products to AbbVie. Their execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness, and safety of our products. This position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement...

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

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 Staff Service Quality Engineer is a critical technical role within the service team responsible for driving service excellence through process optimization, technical support, and cross-functional collaboration. Reporting to the functional site leader, this individual contributor position ensures...

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. Primary Responsibilities Leads complaint investigations, conducts periodic trending of complaint data, evaluates negative trends, assesses risk to released products which aids in determining appropriate field actions and analyzes explants and returned products, as required . Collaborates with cross functional teams like...

About Orthopaedics Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their...

Johnson & Johnson is hiring for a Staff Quality Engineer – Shockwave Medica l to join our team located in Santa Clara, CA. 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...

Johnson & Johnson is recruiting for the Sr Director, Global Leader, Regulatory Data & Process Excellence located at either Raritan, NJ, Titusville, NJ, Spring House PA, Horsham, PA, Allschwil CH, or Beerse, BE. 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,...

Job Title Quality Engineer We are seeking a Quality Engineer to work at our Temecula, CA location in our Vascular division. The Quality provides process/quality engineering support to manufacturing, and helping to ensure delivery of highest quality product to the customer. Provides Process/Quality Engineering support to Quality Control Receiving Inspection, helping to ensure production of highest quality products. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. WHAT YOU’LL DO...

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

Objectives Leads the global Clinical Programs Quality organization, establishing a strategic leadership and oversight of the Takeda’s clinical development programs and ensuring risk-based quality interventions and audits are performed for timely mitigations. Provide quality oversight of R&D's strategic suppliers and service providers, ensuring outsourced activities are carried out with high quality and compliance. Promotes inspection readiness for clinical trials and strategic supplier activities, ensuring preparations, management of and response to clinical pre-approval inspections are resourced, prioritized, and expeditiously reported. Serves as a senior strategic Quality Partner to relevant R&D stakeholders and strategic suppliers. Reports to the Head of CPMQ and...

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...

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...

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 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...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable for management of all assigned programs/products as the internal expert on US and international Codes, guidance, and industry standards pertaining to prescription medicine promotion. How you will contribute As our Associate Director, Global Regulatory Affairs...

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...

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...

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...

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...

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...

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 Advisor – Quality Audit and Compliance is part of...

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

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

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 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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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....

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...

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...

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...