Quality & Regulatory Jobs in Pharma & Biotech

The primary responsibility for the Validation Specialist is the planning and overall approval of validation tasks. Under the direction of the Validation Section Manager, will participate in the implementation of the Validation quality program, but s/he will be expected to independently manage 5+ key projects simultaneously. May be expected to coach/supervise contractors and/or junior Validation Specialists This role serves to provide Quality Assurance oversight of site validation documents/ practices and reports up through the site Quality organization Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements Ensures that all...

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

People-centered, data-driven, connected. We're solving the world's biggest health challenges with healthcare technology. We fuse technology and research for groundbreaking solutions. From less-invasive surgery that minimizes a patient's downtime to the world’s smallest pacemaker, our technology transforms lives. At Medtronic, at our Warsaw production facility, also known as Warsaw Orthopedics, manufactures Spinal Implants and Brain/ENT components. Responsibilities may include the following and other duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications...

This position, Associate Director Regulatory Affairs , works out of our San Diego, CA location in the Infectious Diseases Division. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. We are seeking a highly knowledgeable individual to combine expertise in scientific, regulatory, and business issues...

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...

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. Help us advance our purpose to make life-saving medicines that matter...

We are searching for the best talent for our Manager, MISE Vendor and Quality Management position to be located in Titusville, New Jersey. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at The role Manager, MISE Vendor and Quality Management is responsible for developing and managing the quality...

Biosense Webster a member of Johnson & Johnson's Family of Companies, is recruiting for an Eng Quality Engineering located in Irvine, CA! 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 Senior Quality Engineer – plans, coordinates and executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Involved in New Product Development (NPD) teams and other activities to develop products, design...

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. Import Export Compliance Associate Responsibility Statement As a member of the...

The Regulatory Affairs Director (RAD) , Global Regulatory Strategy will be responsible for the development and implement ation of global regulatory strategies for all assigned products and therapeutic areas, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will, with a high sense of urgency, lead cross-Regulatory teams and be accountable to provide key regulatory input to Global Program and/or Medicine Teams (GPTs/GMTs) deliverables . The individual will also ensure effective communication and constructive working relationships with business partners and representatives of...

Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Lead (GRL) is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi’s diversified portfolio in order to meet corporate and business objectives. This GRL would be in the Neurology Therapeutic Area. Decisions are made in alignment with the TA, GBU Head and up to the GRA LT as needed. The GRL is the primary interface and key strategic GRA partner for the Global Project Team (GPT) and Global Brand Team (GBT). We...

The Cardiac Surgery Business is one of the fastest growing businesses, helping ECMO patients across the globe. We are an inventive and collaborative group. We are dedicated to making sure that every patient gets the best product — when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and access to healthcare. The Quality Engineer II role reports to the Senior Quality Manager. This individual will be part of the Operational Quality team at our Dexter, MI Site. This role supports...

We are seeking a dedicated and detail-oriented Environmental Compliance Specialist to join our North Haven, CT, facility. This role is an exciting opportunity to contribute to Medtronic’s mission to reduce environmental impacts, maintain the safety of our employees, and ensure compliance with environmental and safety regulations. The Environmental Compliance Specialist will help foster a culture of safety, environmental stewardship, and regulatory compliance across the site. Key Responsibilities Ensure environmental compliance for a manufacturing site. Evaluate new construction projects, new processes, process changes, etc. and determines the regulatory impact including the need for permit changes. Implements the applicable regulations / company...

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

The Associate Director, Regulatory Affairs Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. 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 Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters....

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

The Director, Regulatory Affairs - CMC (CGT) is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of AstraZeneca's C ell and Gene T herapies (CGT). This position may be based in Santa Monica, CA or Gaithersburg, M D and reports to the Senior Director, CMC Regulatory Affairs (CGT) . Essential Functions and Responsibilities Provide strategic guidance during all stages of product development and l ead the development and implementation of global CMC regulatory strategies for the pipeline of AZ cell and gene products . Interpret global regulations and guidance to identify...

Careers that Change Lives We are currently looking for a Senior Design Quality Engineer to join our Cranial and Spinal Technologies (CST) operating unit. CST provides a comprehensive portfolio of proven powerful technologies setting the highest standards of integrity and reliability in Cranial and Spinal care. This position is located ONSITE in San Diego, CA collaborating with team in Memphis, TN. In this exciting role, you will have primary responsibility for developing and coordinating quality assurance activities working in a cross functional team setting. This is a dynamic opportunity where you will also be involved in leading production control and...

Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs. In this exciting role as a Supplier Quality Engineer II you will have responsibility for management of suppliers within the Plymouth, MN SQE team. You will be accountable for changes to existing supplied products and processes, as well as oversight of performance and improvement activities. You will also lead the oversight of supplied products, ensuring conformance to purchased materials or finished...

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

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...

As a Sterile Operations, Validation Leader, you will provide guidance and direction to a team of Validation Professionals supporting the construction, start up, commissioning, and qualification of an R&D, clinical manufacturing, Drug Product filling facility. The new DP facility as well as this position will be located in Marietta, Pennsylvania. After the facility is released for GMP manufacturing, the role will include routine validation support of the facility including, but not limited to validation maintenance, Change Control management, new equipment / system introduction, decommissioning, and other validation life-cycle requirements. This role requires consistent and continuous on-site presence. Although the role...

This Computer Systems Validation engineer position can work remotely within the U.S . What You’ll Work On Develop, implement and maintain secure, resilient enterprise-grade cloud processes for multiple software and systems in tandem with architects and system engineers. Lead/support validation efforts and deliverables for projects requiring validation. Work together with development operations and development teams to develop and implement monitoring and security solutions in stand-alone and embedded product software and supporting applications. Create and execute validation test scripts and document test results in accordance with standards. Actively monitor, assess, recommend, and lead tactical and strategic initiatives based on new and...

This Computer Systems Validation engineer position can work remotely within the U.S . What You’ll Work On Develop, implement and maintain secure, resilient enterprise-grade cloud processes for multiple software and systems in tandem with architects and system engineers. Lead/support validation efforts and deliverables for projects requiring validation. Work together with development operations and development teams to develop and implement monitoring and security solutions in stand-alone and embedded product software and supporting applications. Create and execute validation test scripts and document test results in accordance with standards. Actively monitor, assess, recommend, and lead tactical and strategic initiatives based on new and...

This Computer Systems Validation engineer position can work remotely within the U.S . What You’ll Work On Develop, implement and maintain secure, resilient enterprise-grade cloud processes for multiple software and systems in tandem with architects and system engineers. Lead/support validation efforts and deliverables for projects requiring validation. Work together with development operations and development teams to develop and implement monitoring and security solutions in stand-alone and embedded product software and supporting applications. Create and execute validation test scripts and document test results in accordance with standards. Actively monitor, assess, recommend, and lead tactical and strategic initiatives based on new and...

About the role Join Takeda as the Head, Digital Ethics & Compliance for Takeda's U.S. Business Unit (USBU) at the senior director level. You will lead the strategic alignment and integration of global digital risk and control frameworks within the USBU. Your leadership will ensure the implementation and adoption of Digital Ethics & Compliance (DE&C) initiatives to promote responsible innovation and regulatory compliance across Takeda's U.S. operations. Acting as a trusted DE&C authority and collaborator, you will focus on enhancing Takeda's ethical culture, risk management, and compliance standards while leveraging advanced technologies to drive innovation and growth in a compliant...

We anticipate the application window for this opening will close on - 9 Sep 2025 Position Sr. Quality Engineer for Covidien, LP, (a Medtronic company) located in Plymouth, MN. Responsible for ensuring the quality and compliance of the manufacturing processes for a variety of vascular devices including embolic coils, stents, catheters, balloons, aspiration devices, coatings, and guide wires. Leverage Good Manufacturing Practices (GMP) standards and navigate the complexity of government and medical device industry regulations including FDA 21 CFR Part 820, ISO 13485, EU-MDR and BSI standards to ensure products are consistently produced per the quality standards. Coordinate risk...

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 and...

The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on Safety Data Sheets (SDS), product labeling, and SOP’s. This role is crucial in supporting global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications. What You’ll Be Doing ●Initiate, author, and maintain Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global regulations. ●Collaborate with cross-functional teams to obtain necessary product composition data and hazard information for accurate SDS generation. ●Manage the review, approval, and distribution of SDS to internal and external stakeholders....

The Principal Compliance Audit Specialist focus will be primarily medical device software, product security, 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 and knowledge working with regulated medical devices and cybersecurity requirements. Manage and oversee internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding...

Position Overview The West Point Quality organization ensures our products are manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our West Point campus, internal manufacturing facilities, external contract manufacturers and suppliers we create a global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The West Point Quality organization is a team of leaders who exemplify and cultivate our company's enterprise leadership skills and ways of working, fostering a culture of collaboration, innovation, and accountability...

We are searching for the best talent for a Senior Regulatory Affairs Program Lead to support our Robotics & Digital Surgery team. The preferred location for this role is Cincinnati, OH however Santa Clara, CA is also available as a location . This role will work a Flex/Hybrid schedule with 3 days per week in-office. There is NO remote option . Relocation assistance may be available on a case-by-case basis. Purpose In joining our growing regulatory team, the Sr. Regulatory Affairs Program Lead will help Robotics & Digital Solutions reach US and international regulatory (NPD) approval goals. Under minimal...

This position works out of our Abbott Park, IL location within the Abbott Quality and Regulatory Corporate Headquarters and/or any Abbott location for the right candidate. The function of the Quality Program Manager is to provide leadership, oversight, and project management covering external inspections as related to Abbott's Quality System. This includes division / business support, quality/regulation expertise and consulting activities. As the Manager of Quality Assurance, you’ll have the chance to provide leadership for pre-inspection, during inspection, and post inspection support. This support encompasses FDA inspections for the Nutrition, Medical Device, Diagnostics, and Pharmaceutical sectors within Abbott. What You’ll...

This role offers an exciting and challenging opportunity that will be key to Gilead's success as we advance new combination products, such as vial kits and pre-filled syringes, to market. You will be a key Quality leader responsible for managing compliance for combination products compliance at Gilead La Verne site. We are looking for an experienced Quality professional to ensure that our QMS provides comprehensive support of these combination products. Roles/Responsibilities Monitor medical device standards for quality management system (QMS) updates to ensure adherence to global regulations Monitor device/combination product enforcement trends in the industry and develop recommendations and action...

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. We are seeking a strategic and experienced Senior Director of Drug...

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 a Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high level 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. Join Takeda as an Associate Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff....

This is a key quality assurance role reporting to the Quality Assurance Manager. This position performs as a Senior Analyst in Quality Assurance oversight of operations, production, process and equipment systems and computer validation at the Bioscience Laboratories Irvine (BLI). This position is responsible for one or more of the following duties or activities Provide QA oversight of operational activities, production, validations, and Technical Services projects. Ensure that QA systems and manufacturing/engineering systems undergo an independent assessment to eliminate any potential conflict of interest between ownership and administration. Review and approve Quality System documents SOPs, validation and technical protocols/reports. Review...

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

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

Responsibilities may include the following and other duties may be assigned. Support review of advertising and promotional material to ensure that it meets all medical, legal, and regulatory (MLR) process requirements. Facilitate review meetings online and offline coordination with authors, reviewers/approvers to get content approved to support business needs. Act as SME for Neurovascular Ad Promo process, providing guidance to authors and reviewers on regulatory and internal policy requirements. Support the preparation of US and International promotional labeling material, including the creation of a claims matrix database and claims objects. Lead AI/ML adoption in content and claims management to support...

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

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...

Janssen Biotech, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Lead at the Spring House, PA campus! At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part...

Johnson & Johnson is hiring for a Principal Quality Engineer (Hardware/Software) – 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...

Johnson & Johnson is hiring for a Quality Engineer Manager – 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 hiring for a Principal Quality Systems Specialist – 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...

Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance (QA) Associate II at the Spring House, PA campus! 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....

FUNCTION Regulatory Affairs (RA) Global Labeling POSITION OVERVIEW Regulatory Affairs Global Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Global Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling...

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 Biosense Webster, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer in Irvine, California. The purpose of this position is to ensure that the Company will develop its products in compliance with the quality assurance system throughout the product lifecycle. Key Responsibilities The scope of QA activities; company adherence to QA standards and processes; internal and external...

GSK is currently looking for a QA Compliance Lead to join our team in Rockville, MD. In this role you’ll lead the site to ensure all relevant Quality Systems are in place, in use and effective to ensure an environment whereby the site is inspection ready and able to support successful regulatory, third party and central inspections. Key Responsibilities Manage end to end third-party, central and regulatory inspections Participate in regulatory agency audits and act as an SME on Quality topics. Manage Quality Risk Model Manage various QA databases Manage Management Review by Quality Council preparations and output Write and...

We are seeking a strategic, experienced, and proactive Chief Compliance Officer (CCO) to lead and manage the global compliance and privacy functions for Medtronic Diabetes – a $2.8 billion medical device business that has recently announced that it will be spinning out into a standalone public company. Reporting to the company’s General Counsel, the CCO will be responsible for overseeing a comprehensive compliance program that ensures adherence to all applicable regulatory requirements, industry standards, ethical practices, and internal policies—across all regions of operation. The CCO will also lead the company’s global privacy team, ensuring compliance with global data protection regulations...

About the role As a Quality Validation Associate II, you will support site projects, technical transfers, and ongoing validation maintenance. You will be responsible for compliance during the review of the design, authorship, and execution of commissioning, qualification and/or validation studies for the any or more of the following major disciplines computerized systems validation (Honeywell, DeltaV, PLC based systems, DHS), facilities, Utilities, and Equipment (FUE) qualification, electronic Batch Management (EBM), cleaning validation, QC Laboratory, or data Integrity Assessment. How you will contribute You will be responsible to maintain validation documentation aligned with Good Documentation Practices (GDP) and ensure compliance with...

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. What You Will Achieve In this role, you will Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements. Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution. Conduct statistical analysis of testing results...

Position can be based onsite in Minneapolis, MN; Lafayette, CO; Memphis, TN; or Jacksonville, FL. This role is part of the Medtronic Clinical & Regulatory Solutions (MCRS) organization, focusing on enhancing regulatory systems and processes. Key responsibilities include collaborating with the Registration and Listing Value Stream team to manage daily operations related to FDA Establishment Registrations, Device Listings, annual registration, and internal and external audits. This position also manages the Owner/Operator (O/O) account and provides guidance to Official Correspondents (OC), US Agents, and OU Regulatory teams. Additionally, there are opportunities to contribute to the Unique Device Identification (UDI) system and...

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 An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for a Sr Quality Review Specialist to be in Danvers, MA . Duties and Responsibilities Perform reviews of Device History Records (DHR) on the production floor for compliance to procedures, including good documentation practices (GDP), documented test results within specification,...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing...

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

Position The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories (Research & Development) by Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines. Contributing to the continuous improvement of the operating model for regulatory activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy. Providing quality advice to stakeholders creating optimal development, commercialization, and drug/delivery device supply strategies Building our leadership...

The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients (API), biologics, vaccine drug substances and finished products. As Director, you will support Quality audits and health authority inspections and ensure any resulting corrective and preventative actions (CAPA) are effectively implemented. Primary Activities Serve as a subject matter expert for current good manufacturing practice (CGMP) requirements for vaccine and large molecule manufacturing Partner with our Company and CMO management to identify appropriate CAPA to address findings identified during audits and inspections. Monitor CAPA status and ensure...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Operations Compliance Engineer Senior is responsible for the daily activities at the Northborough facility, in partnership with his/her team and peers, to achieve business objectives aligned with site priorities. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives....

Position Description Perform procedures required for testing samples in compliance with current good manufacturing procedures (cGMP), safety and environmental guidelines, including clean room entry and aseptic procedures. Meet testing schedules, which may include working longer hours to complete testing and cleanup. Maintain accurate and compliant documentation. Assist in reviewing and updating current procedures for equipment and processes. Assist in planning, development and implementation of new procedures or special projects, resolution of testing issues by recommending solutions to issue or routes of investigation. Assist in cleaning and sterilization of equipment used in the department as well as cleaning work areas (including...

We are looking for the best talent for a Senior Quality Engineer to be located in Cornelia, GA with occasional travel to Athens, GA. 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 You will be responsible for Determine quality standards and ensure compliance with industry regulations. Develop and implement quality control processes to ensure flawless production. Collaborate with diverse teams to identify areas for improvement and implement effective solutions. Conduct thorough product...

Use Your Power for Purpose At Pfizer, the impact you will have on improving patients' lives is profound. You will play a crucial role in navigating and interpreting the growing regulatory demands to ensure optimal patient care. Your expertise and commitment are crucial in adapting to these changes and maintaining the highest standards of patient care. Join us in our mission to make a global impact on patient care. Role Summary You will support the administration of the Vaccines Quality Records and Training Compliance team in accordance with Records Management policies and procedures and the Enterprise Records Retention schedule. You...

Purpose Primarily responsible for conducting audits of investigative clinical sites in R&D to assess and assure compliance with regulations, guidelines, policies, procedures and sponsor requirements Responsibilities Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures. Lead investigation site audits to ensure compliance to global regulatory requirements as well as AbbVie requirements. Effectively communicate audit results, both orally and in writing. Review corrective action plans/audit responses for adequacy and approve if adequate Lead Global System Audits to evaluate internal Abbvie areas for compliance to applicable SOPs and local regulations Review clinical research documents, such as research...

POSITION LOCATION San Carlos, CA, Austin, TX, or Remote USA POSITION SUMMARY Software Quality engineer, Data is responsible for developing and maintaining software automation test frameworks and tools using programming languages and test automation libraries. PRIMARY RESPONSIBILITIES Responsible for supporting test infrastructure of Natera software systems and components. Design, build, and maintain data-driven test automation tools and frameworks using clean coding practices and functional programming methodologies. Perform debugging and root cause analysis of product issues or defects. Perform system analysis, assess risk, and develop strong test strategies by analyzing product design and technical specifications, and by collaborating...

Join us as the Quality Center of Excellence Lead at our Wilmington Biotech site, where you'll shape the future of breakthrough medicines by ensuring top-tier quality and compliance with global regulations. Lead a high-performance team, drive commissioning and validation excellence, and collaborate globally to deliver life-changing therapies right first time to patients worldwide. If you have 10+ years in Quality Assurance and a passion for innovation and leadership, this is your opportunity to make a global impact. & SPECIFIC OBJECTIVES The Quality Center of Excellence (COE) Lead role will involve establishing the Quality COE structure at the Wilmington Biotech...

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

We have an immediate opportunity for a Manager Quality Assurance in our Abbott Park , IL location. What You'll Work On Primary Job Function The function of the Manager, Quality Business Support – Technical Design Quality is to provide corporate-wide support of Abbott’s Quality System and product submissions. The candidate must possess a working knowledge of Quality System requirements, design controls and risk management, as well as an understanding of the US IVD regulatory submissions process and required contents. The candidate must have experience in product design quality and technical (R&D, Technical Support, or manufacturing) roles. The primary activities and...

Senior Quality Engineer for Cardiac Rhythm Management, this position is based in Arecibo, Puerto Rico. This position is based in Arecibo , Puerto Rico for our Cardiac Rhythm Management Division. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks . As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats . As the...

Johnson & Johnson is currently recruiting for a Senior Quality Assurance Specialist, Investigation & CAPA ! This position will be located in Gurabo, PR. 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 tomorrow's breakthroughs and profoundly impact health for humanity. Learn more at . ...

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

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. What You Will Achieve In this role, you will Oversee quality activities, including change control systems and product change control oversight, in collaboration with Regulatory Affairs and APR program management. Support non-manufacturing functions, strategic quality planning, and manage performance metrics and quality goals. Review and...

Your skills could be critical in helping our teams accelerate progress. Sanofi is an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities Advice and guidance based on integrated safety review Provide expertise on translational safety science for early development projects to ensure translation of non-clinical and emerging preclinical data into potential clinical risk Support...

The Opportunity At Roche, our commitment to quality in Pharma Development is unwavering. We aim to deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society. As a Quality Excellence Lead , you will play a pivotal role in driving excellence across our global quality landscape, from Good Clinical Practice (GCP) and Pharmacovigilance (GVP) to Medical Device Regulations (MDR) and beyond. Different roles are available to successful candidates, one of which includes Global Process Ownership for managing unplanned Quality Events. This is your chance to shape quality strategies and deliver impactful...

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

of a Post-Market Risk, Quality Engineering Manager – reporting to Director of Post-Market Risk, Surgical Operating Unit. Responsibilities may include the following and other duties may be assigned. Plans, manages and implements aspects of the Surgical Operating Unit’s (SOU) Post-Market Risk Management of medical device products or software systems. May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products in support of Post-Market Risk Leads the investigation and evaluation of risk of production and field issues. Manages the Post-Market Risk Quality Engineers...

SENIOR REGULATORY AFFAIRS SPECIALIST In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. Saving lives for us is not just a cliché but is part of our everyday DNA. Real people with debilitating conditions can now be given back active lives through the restorative therapies that we provide. Therefore, we are looking for passionate engineers who are excited about working in the software field and...

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 and...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. This Quality Control Analyst II is responsible for performing routine and complex testing of in-process samples, stability samples and final products in accordance with SOPs for product release and validation. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives....

We are seeking a Quality Engineer II who is passionate about ensuring product quality and regulatory compliance in support of innovative medical devices. In this role, you’ll contribute to cross-functional efforts and continuous improvement in a dynamic, collaborative environment. In this role you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initia tives. This is an onsite role at the Danvers, MA location. As a Quality Engineer II, you will Support product and process...

Prin . Software Design Quality Engineer Medtronic ENT (Ear, Nose, and Throat) is an operating unit within Medtronic’s Neuroscience Portfolio. The unit focuses 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 Prin. Software Quality Engineer. This position is based onsite in Jacksonville, FL. In this role, you will serve as an individual contributor with responsibilities in our technical functions to advance existing technology or introduce new technologies and therapies. You...

Johnson & Johnson is currently recruiting for a Director, External Quality-Advanced Therapies! This position can be located in Horsham, PA, Raritan, NJ or Maryland. At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science...

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Our location in Sylmar, CA , currently has an opportunity for a Software Quality Engineer II . This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for...

As a Quality Technical and Validation Manager, you will be responsible for overseeing the technical quality assurance and validation activities to ensure compliance with regulatory requirements, industry standards, and GSK policies. You will play a critical role in maintaining the highest levels of product quality and safety. This role leads a team that has responsibility and accountability for ensuring the highest standards of GxP compliance in the validation and qualification of processes, equipment, and systems within GSK's manufacturing and analytical environments. This includes overseeing new product introductions (NPI) and associated manufacturing and analytical activities, ensuring seamless introduction of products from...

This position works out of our St. Paul, MN 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 Supplier Development Quality Engineer II , you’ll have the chance to develop components and associated quality requirements for new product initiatives. This position is responsible for managing supplier relationships, qualifying components and developing incoming controls that will drive the quality of future components. This will include technical support in the selection of suppliers and...

This position Medical Director, Patient Safety and Compliance, works out of our Lake Forest, IL location in the Infectious Disease Business Unit in Abbott Rapid Diagnostics. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges. What You’ll Work On This position will manage Patient safety to provide medical risk and sexual transmitted diseases (STD) guidance for the business group, including support to maintain focus on product performance and safety, product/program development and customer education. The director hired will work cross functionally to support lateral flow technology (LFT) in sexual transmitted diseases (STD), and provide input...

Nourish the world and your career as part of the Nutrition team at Abbott. Abbott’s Nutrition Division 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 get the nutrients they need to live their healthiest life.. WHAT WE OFFER AT ABBOTT At Abbott, you can have a good job that can grow into a great career. We offer Career development with an international company where...

About This Role The Senior QA Associate II in the Quality Systems organization is responsible for understanding quality systems, contributing to oversight of quality systems, and maintaining GMP and laboratory activities at the Biogen RTP facility. They should be proficient in their understanding of the quality systems and apply that knowledge in coaching and continuous improvement. The primary responsibilities of the Senior QA Associate II in the Quality Systems team include quality compliance for managing Drug Substance (Bio) Quality Systems, responsible as the Business Process Owner for the document issuance process, authoring Site Reports (Site Management Review Report), change control...

The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Nellcor™ Blood Oxygenation Management Franchise within the Acute Care and Monitoring Operation unit. Activities include participation in change development projects, review and approve design control documentation, regulatory change assessments, author regulatory documents (MDR Technical Documents, STEDs or 510ks) and supporting EU MDR implementation. The Sr. RAS role translates regulatory requirements into project/product requirements and collaborates cross-functionally, while ensuring timely and high-quality execution of assigned regulatory deliverables. This position is most suited for individuals with a broad background covering the total regulatory...

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

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

The Sr Regulatory Affairs Specialist will play a key role in sustaining the current product portfolio. The Sr Specialist has responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining regulatory responsibilities include reviewing changes to ensure that regulatory requirements continue to be met, documenting “no file” decisions, reviewing promotional materials, submitting product changes and annual reports, and ensuring that our product technical documentation is current and accurate. SENIOR REGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR In the Neurovascular Operating Unit, we are committed to delivering meaningful innovation to advance...

We are searching for the best talent for a Principal Regulatory Compliance Specialist to be located in Danvers, MA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Purpose The position of the Principal Regulatory Compliance Specialist is responsible for establishing and maintaining robust Compliance Programs at the designated Abiomed sites in order to ensure compliance to local, national and international regulatory requirements, company policies and procedures and J&J corporate requirements. The Principal...

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...

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...

The mission of our company’s Research Laboratory Quality Assurance is to safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies. The Compliance and Quality Management Systems (CQMS) organization is part of the larger Global Development Quality (GDQ) organization within our company's Research Laboratory Quality Assurance and is accountable for the execution of critical activities in the areas of compliance, quality systems, regulatory intelligence, and the Quality Management System (QMS). The Global Quality Systems role...

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 Eli Lilly, we create medicines that give people new hope...

Summary/Scope Bristol Myers Squibb (BMS) is a global biopharmaceutical company engaged primarily in the discovery, development, and commercialization of novel therapies for the treatment of human diseases. The Lab Planning and Execution group is part of the Translational Science (TS) team within Translational Medicine (TM). TS leads internal and external diagnostic research & development activities to support multiple disease areas of interest including hematological malignancies, inflammatory disease programs, neuroscience, cardiovascular, fibrosis, and solid tumor indications. The TS team integrates scientific and business insights of multiple functions to provide innovative solutions that will make precision medicine a reality for the patients...

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...

Staff Quality Auditor This role for the Staff Quality Auditor will serve as experts for the compliance team with respect to observation tracking, auditing, regulations and standards and the Division quality system. This role will conduct internal quality audits to assess compliance to the requirements of the quality system, as well as FDA, ISO, MDD, CDR, MHLW, and other regulations applicable to the CATD Quality System. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday. What You'll Work On Plan, perform, support and document...

This is a full time, on-site position About This Role This position will support our drug substance (Bio) site at our Research Triangle Park NC facility. The primary responsibilities of the Senior Associate III include quality compliance for managing site inspections, completing regulatory requests for partner and Biogen products, authoring Site Reports (Site Management Review Report and Site Master File), change control support, and the review and approval of site-specific GMP documents (Work Instructions, Master Production Records, and Solution Records) for compliance to applicable regulatory and corporate guidance documents, and consistency with business source documentation. What You’ll Do Management 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. This is an exciting opportunity to help a state-of-the-art facility and...

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients. What You Will Achieve In this role, you will Represents Sanford Quality for all technical transfer activities at site Manages Change Management responsibilities, deliverables, and metrics within the team to ensure compliance with Pfizer standards and metrics Appropriately manage team workload to drive project timelines in a...

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

Johnson & Johnson is hiring for a Sr Regulatory Affairs Specialist – Shockwave to join our team located in Santa Clara, CA or Remote. 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...

Johnson & Johnson is hiring for a Sr. Regulatory Affairs Specialist (Remote) – Shockwave Medical to join our team located in Santa Clara, CA and Remote 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 for...

That’s what makes us Roche. This position is within the Pharma Technical Quality Organization, which is committed to delivering the highest quality products to our patients. Within the Quality Organization, we are the Reference Standard Management (distribution) Center managing the end-to-end processes for reference standards and critical reagents for Roche's commercial products globally. As a member of the reference standard management center, your main focus will be on supporting the management of reference standards and critical reagents—from manufacturing to distribution—to ensure the delivery of Roche products to patients. You'll collaborate with cross-functional global teams, development teams, QC test sites,...

This Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment. In this role, you will combine knowledge of scientific, regulatory, and business issues to enable products...

This position works out of our St. Paul, MN 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 Senior Supplier Development Quality Engineer , you'll have the chance to develop components and associated quality requirements for new product development initiatives. This position is responsible for managing supplier relationships, qualifying components and developing incoming controls that will drive the quality of future components. This will include technical support in the selection of suppliers...

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. What You’ll Work On Preparation of regulatory submissions for Electrophysiology devices to achieve departmental and organizational objectives. Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities. Acts as...

Medtronic ENT (Ear, Nose, and Throat) is an operating unit within Medtronic’s Neuroscience Portfolio. The unit focuses 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 Senior Software Quality Engineer. This position is based onsite in Jacksonville, FL. In this role, you will serve as an individual contributor with responsibilities in our technical functions to advance existing technology or introduce new technologies and therapies. You will be tasked with formulating, delivering,...

Sr. Quality Compliance Specialist We are seeking a detail-oriented and proactive Compliance Specialist to join our Compliance team. This role is critical in maintaining a state of continuous inspection readiness and ensuring compliance with applicable regulatory requirements, including ISO 13485 and MDSAP. The Compliance Specialist will lead and support internal and external audits readiness activities, manage audit-related documentation, and drive quality system improvements. What You'll Work On Maintain and continuously improve the inspection readiness program to ensure the site is always prepared for regulatory and internal audits. Coordinate and support internal audits, including planning, execution, reporting, and follow-up on...

This position works out of our St. Paul, MN or Santa Clara, CA location in the Cephea 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. This position provides leadership and guidance for the supplier quality engineering department; responsible for developing goals, objectives, procedures, policies and systems that are in line with company goals and objectives, mission and vision and FDA/ISO regulations. Daily responsibilities include managing the resolution of supplier quality/process issues, ensuring a continuous supply of high quality components to production and...

Project Leader (TPM – Third Party Manufacturing) Quality Working at Abbott 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. 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...

Job Purpose Ensure the development of appropriate regulatory strategies and their execution for assigned Vaccines asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data. Key Responsibilities Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategies and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned...

Reporting to the Chief Privacy Officer, the “Director, U.S. Privacy Compliance Lead” is responsible for the development, maintenance, and maturity of all aspects of AbbVie’s U.S. data privacy compliance obligations. The role is accountable for all aspects of U.S. data privacy support for AbbVie commercial and corporate functions. The role will also support the intersection of U.S. privacy compliance with AbbVie’s global privacy compliance program to accelerate the maturity of AbbVie’s Global Privacy Office, enterprise data enablement, and risk mitigation. Manage and provide strategic leadership to the development, strategy, and ongoing maturity of AbbVie’s U.S. privacy compliance program and synergies...

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

The Director, Global Regulatory Science CMC will be responsible for leading regulatory CMC activities for one or more products, depending on complexity, through all stages of a product’s lifecycle. The Director will manage a small group of individuals responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities. The Director will be expected to provide guidance to the product teams supporting products in their portfolio. In addition, the individual will be responsible for preparation, review, and approval of CMC and Quality related Health Authority correspondence and regulatory applications. The...

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

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. Responsibilities Responsible for leading all CMC regulatory activities for assigned project(s), in line with ICH requirements, regional requirements, scientific knowledge, and company policies and procedures. Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. Actively collaborates with internal teams (including Technical Development, Manufacturing, Supply Chain and Quality) to identify and rank risks, propose risk mitigation plans, and execute robust CMC regulatory strategies. Leads CMC regulatory project teams and serves as core member of cross-functional PDM strategy teams....

The Associate Compliance Director will provide direct oversight for moderate to complex elements of AbbVie’s compliance program for the Specialty Therapeutics organization. Responsibilities of the Associate Compliance Director, Specialty Therapeutics include but are not limited to Partners with all levels of key business functions to provide moderate to complex OEC and functional policy interpretation and provide guidance on the requirements. Conducts compliance risk assessments, trend analysis and provides recommendations for compliant business activities. Conducts policy and procedure reviews and updates related to OEC policy and functional procedures ensuring clarity, applicability and compliance. Develops, delivers and updates OEC’ s comprehensive training...

General/ The Director, CMC Inspection Management as part of the Vertex Quality Assurance Organization is responsible for the inspection management related to CMC activities of the internal manufacturing site for Cell & Gene. This role will be responsible for the development of an inspection program for site compliance and maturity, inspection preparation, consistent state of readiness and inspection management. The role is responsible for designing the program, identifying risks, driving mitigation of such risks and supporting cross-functional partners in ensuring execution. Additional responsibilities include support for external site inspection readiness. Vertex is an exciting, fast paced dynamic environment with a...

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

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

POSITION OVERVIEW Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies. You will manage the commercial regulatory strategy and execution of such for multiple high-volume and/or otherwise...

Knowledge Comprehensive knowledge of pharmaceutical contracting, rebate and payment processes, and various market segments (Commercial, Medicaid, ADAP, 340B, Trade). Thorough knowledge of SOX principles and processes. Excellent cross-functional capabilities within the department, as well as with IT, SOX PMO, Legal, Finance, internal/external auditors, and vendors. Extensive Project and Vendor Management experience, including audits (govt pricing preferred), projects, budgets, analyses, and assessments. Ability to recognize and interpret business issues/opportunities, analyze, make recommendations, and implement solutions. Robust understanding of 340B regulations, legislation, rules, and guidance. Strong familiarity with current government legislative issues and regulations. Experience with data analysis, systems, and working...

SHE Compliance Manager Introduction to role Are you ready to take on a pivotal role in ensuring safety, health, and environmental compliance? As a SHE Compliance Manager, you'll be at the forefront of driving compliance initiatives and fostering a culture of safety and sustainability. This is your chance to lead and innovate within a dynamic team, making a tangible impact on our operations and the lives of patients worldwide. Accountabilities Act as an active leader within the SHE Team contributing to ensuring the overall delivery of SHE compliance matters. Establish and maintain an active compliance registry and license to operate...

Your skills could be critical in helping our teams accelerate progress. The Associate Director, Global Regulatory Affairs – Global Labeling Strategy is responsible for leading the development, maintenance, and implementation of global labeling strategy for assigned products, including those in clinical development, life cycle management (LCM), and the marketed portfolio. This role leads the creation and update of core labeling documents (e.g., Company Core Data Sheet) and regional labeling (e.g., US Prescribing Information, EU SmPC), ensuring alignment with regulatory requirements and Sanofi’s product positioning. The Associate Director contributes to early development activities by providing regulatory input into clinical development plans,...

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

About This Role This is a full time, on-site position with M-F business hours The Sr Associate I, Quality Assurance has the working understanding, full knowledge and ability in their primary discipline. They are able to apply technical principles, concepts and understanding of systems and procedures in order to conduct quality and compliance related activities. They are proficient in their understanding of the Biogen Quality Systems. The Sr Associate I QA has working knowledge of GxP regulations and adheres to all regulatory licenses and regulations as well as internal SOPs. The Sr Associate I QA identifies and resolves issues through...

Director of Validation, Cell Therapy Technical Operations reports to the Senior Director, Cell Therapy Technical Operations within the Cell Therapy Development and Operations (CTDO) organization. This Technical Leadership role will provide Technical oversight to drug product and vector sites, covering process validation for commercial cell therapy products manufactured globally via internal and external manufacturing sites. This role will serve as the Global Technical SME for Drug Product and Vector Validation. The lead will develop global technical standards for cell therapy validation and deploy the standards to site MS&T at internal and external sites. The validation lead is accountable for developing...

Key Responsibilities Responsible for Supplier Quality Management cycle. Primary contact with suppliers on all quality related issues during both supplier maintenance & supplier selection process. Oversee supplier quality management activities & continuous improvement initiatives with suppliers. Plan & lead required supplier audits. Establish & maintains supplier quality metrics, scorecards, & trending. Generate quality plans & define risk control measures for continuous improvement. Conduct Design of Experiments (DOE) & Process Characterization for process optimization &/or improvement by conducting analyses using statistical techniques, including Gage Repeatability & Reproducibility (Gage R&R), Tolerance intervals, & Process Capability assessments with Cp or Cpk Lead or...

This position works out of our Santa Clara, CA location in the Cephea 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. This position provides leadership and guidance for the quality engineering department supporting new product development. Responsible for developing goals, objectives, procedures, policies and systems that are in line with company goals and objectives, mission and vision and FDA/ISO regulations. Supports the development and implementation of new processes and designs. Daily responsibilities include managing the technical support for new product /process...

Candidate will work primarily in the Endoscopy Returned Product Analysis lab, performing tasks including device intake and disposition, shipping devices to other facilities for processing, and some product analysis. Responsibilities may include the following and other duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from customers, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property. Performs intake and staging of customer returned product. Performs required inspections, checks, analysis and documentation of customer returned products. Prepares and...

This position works out of our Abbott Park, IL location in the Abbott Quality and Regulatory (AQR), Global Quality Operations team. As a Sr. Quality Engineer/Analyst within Global Quality Operations, you will provide high quality support for metrics and management review within the Abbott Quality and Regulatory division. You will interact with all Abbott divisions to collect quality metrics and identify areas of risk. What You’ll Work On Build positive relationships with all Abbott divisions and stakeholders who drive metrics and management review, participate and drive an active community of practice (CoP) Support key business processes related to Competitor Analysis,...

As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory approval, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for clinical trial operations and product market entry. What You’ll Work On Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Reviews and provides input on device labeling. Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory...

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

Project Manager, Global Affiliate Compliance Responsible for driving CAPA projects through its entire lifecycle, working closely with Commercial Affiliates. Communicates project updates and identifies areas for improvement while defining / implementing solutions as the key contact for new or updated process requirements to the Commercial Affiliate organization. This role will also be responsible for reviewing, updating, and maintaining Commercial QA KPIs, while providing strategic input to contribute to overall business efficiency. Other responsibilities may include providing support on any other improvements related to Commercial Affiliate processes when necessary. This position will be based out of Abbott Diabetes Care in...

About This Role As the Global Trade Compliance Operations Specialist, you will play a pivotal role in ensuring efficient and compliant cross-border trade activities for Biogen. You will be responsible for managing day-to-day import/export compliance operations, as well as Foreign Trade Zone (FTZ) Customs requirements, ensuring compliance with international trade laws. Acting as a key liaison among internal teams, customs brokers, government agencies, and other stakeholders, you will streamline import/export clearance by U.S., and Canada Customs, as well as other government agencies proactively. Additionally, you will serve as the subject matter expert for the global trade management system (GTM), providing...

About the role As a Quality Control Senior Analyst, you will focus on the daily lab operations and execution of testing to support manufacturing operations/validation or development studies. Testing may include samples from drug substance/product and multiple protocol studies using test methods derived from the compendia and non-compendial sources. You will maintain operational and GMP readiness of the QC area. Also, you will participate in more complex projects, operational excellence initiatives including 5S/lean improvements, method/equipment validation, method transfer and multiple quality systems (deviations, change controls, investigations), and maybe asked to take lead roles for the QC organization on these projects....