Quality & Regulatory Jobs in Pharma & Biotech

We anticipate the application window for this opening will close on - 23 Jul 2025 Position Principal Quality Engineer for Medtronic, Inc. located in Northridge, CA. Responsible for product quality of devices within the Diabetes Business Unit. Collaborate with manufacturing, operations quality, regulatory and research & development to ensure therapy continuity for Diabetes patients. Provide Quality Engineering support for Diabetes products ensuring all devices meet necessary compliance, performance, and safety requirements. Navigate the complexity of government and industry regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, and European Union Medical Device Regulation (EU MDR)....

Our location in Lake Forest, IL has currently an open position for a Sr. Manager, Customs and Trade Compliance in the Core Diagnostics Division supporting Immunoassay, Clinical Chemistry, Transfusion Medicine, Hematology, and our instrument and automation product families. This role will provide divisional leadership and support to ensure compliance with all relevant US customs regulations and trade laws and regulations, including 19CFR,15CFR, FDA, USDA, and other US regulatory agency requirements. Responsible for supporting the development and implementation of division-level policies and strategies and ensuring that appropriate actions are taken by the sites. It will be the responsibility of this position...

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our...

The SOX Compliance team is part of the Controllership group at Gilead and is responsible for the SOX internal controls over financial reporting. This is an audit advisory role with cross-functional involvement with U.S. and international finance teams and business partners. As the Associate Director, SOX Compliance & Controls key areas of responsibility include design of key controls (business processes, interfaces, and IT application controls), identification of audit process improvements, financial reporting risk mitigation, and remediation of control deficiencies. As part of this unique business structure, the SOX PMO group works closely with external auditors and Gilead Internal audit teams...

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities This role reports into the Assoc. Director of Compliance and will report to a cluster lead for the EMEA / AP or US region....

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The senior specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities This role reports into the Assoc. Director of Compliance and will report to a cluster lead for the EMEA / AP or US...

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. It's never been a better time to be a part of...

We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and Monitoring (ACM). In this role you will play a key role in the lifecycle management of Medtronic products that get integrated with our strategic partners. You will be responsible for engaging with strategic partners in integration projects, preparing and submitting regulatory filings for the U.S. and EU market and managing global compliance. You will collaborate closely with engineering, marketing, clinical, quality as well as the regional and international teams working with integration partners to support the submission process and ensure regulatory requirements are...

Surgical Quality leader for NPD systems quality, hardware quality and reliability. Responsible for setting direction for functional development and program execution to achieve portfolio quality goals. A quality functional director has strong leadership in both people leadership and functional development to support the new product development portfolio. This position will require setting a strategic direction for developing the reliability engineering competency and for elevating the talent and competency within systems and hardware quality. Accountability for program execution, resource planning, talent development, hiring, and functional excellence. This role requires the ability to navigate the matrix organization and engage with program and...

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

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

This position works out of our Sylmar, CA location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Mechanical Development Quality Engineer I assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs What You’ll Work On Execute and support on-time completion of Design Control Deliverables. Support...

Senior Manager Software Compliance Nourish the world and your career as part of the Nutrition team 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®, Glucerna® – to help get the nutrients they need to live their healthiest life. WHAT YOU’LL DO MAIN RESPONSIBILITIES Lead team responsible for software quality assurance validation efforts and system compliance to federal regulations (e.g. 21 CFR Part 11, cGMP,...

Responsibilities may include the following and other duties may be assigned. Performs physical evaluation and testing of returned medical devices with a focus on identifying failures and root cause analysis. Collaborates with engineering, manufacturing, and design teams to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating product quality. Designs SOPs and work instructions governing the receipt, inspection, evaluation, testing, and decontamination of post-market surgical devices. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. TECHNICAL SPECIALIST CAREER STREAM An individual contributor with responsibility in our...

The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta. This is an onsite role based in Santa Rosa, CA. In this exciting role as a Principal Quality Systems Compliance Specialist you will have responsibility for compliance to Quality System processes including External and Internal Audit processes to Medical Device regulations and requirements. 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. Will monitor and approve cleanings for the manufacturing rooms and equipment...

Associate Quality Control - Microbiology Laboratory What you will do In this vital role, you will be responsible for analytical testing, sample and data management, method development, and product characterization. You will support Quality Control operations in a non-standard shift environment, helping ensure the highest standards of product quality and compliance. Key Responsibilities Perform routine and non-routine laboratory procedures, including aseptic aliquoting, sampling, and analysis for both compendial and non-compendial methods. Conduct or support activities such as sample testing, standards and reagent preparation, environmental monitoring, sample management, and equipment maintenance. Ensure accurate, complete, and timely documentation of laboratory work,...

Johnson & Johnson is hiring for a Regulatory Affairs Specialist – Shockwave 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 of...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. This position ensures Quality Compliance oversight with cGMP, Regulatory, and Internal requirements regarding the manufacturing, testing, and distribution of products through formal QA audits, change controls, investigations, development of corrective and preventative actions, training and review and approval of procedures, protocols and reports. Evaluate and provide QA recommendations on all...

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. Provides leadership and technical engineering expertise for quality processes, procedures, troubleshooting, investigations, improvement projects, capas and change controls. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career,...

As the Sr. Clinical Quality Assurance Manager at Neurocrine, you will be a pivotal leader in ensuring the highest quality standards are upheld across our diverse clinical research portfolio. Leveraging your deep expertise in Quality Assurance, you will spearhead CQA activities that support the development and commercialization of transformative therapies, primarily in neurology with support for psychiatry therapeutic areas. Your QA leadership and training will be instrumental in driving adherence to all relevant regulatory requirements and internal policies and procedures. You will partner closely with cross-functional teams to implement robust quality systems and processes that mitigate risks and position our...

ModernaTX, Inc. seeks a Specialist, Quality Assurance for its Norwood, Massachusetts location. Here’s What You’ll Do Provide quality on-the-floor support of manufacturing, reviewing documentation, and providing real-time support of manufacturing issues and change overs. Assist with troubleshooting equipment. Participate, support, review, and approve the authoring of quality systems records such as investigation, deviations, change controls, Corrective and Preventative Actions (CAPAs) and Stability program support. Support quality decisions that may impact operations, ensuring appropriate escalation. Review data entry and support Stability trending data. Collaborate with Manufacturing to support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping, managing and stocking...

Director, Devices & Combination Products Complaints QA We are seeking a highly motivated and experienced Director of Combination Products Complaints QA to join our team. This role is responsible for leading and supporting the complaints management processes for combination products with a focus on auto-injectors, pre-filled syringes and other innovative drug delivery systems. The ideal candidate will have a strong background and deep expertise in complaint management systems, regulatory reporting and post-market surveillance for combination products. The ideal candidate should also have a proven track record of establishing and managing compliant, scalable complaint processes across pharma, biotech or medical device...

The SOX Compliance team is part of the Controllership group at Gilead and is responsible for the SOX internal controls over financial reporting. This is an audit advisory role with cross-functional involvement with U.S. and international finance teams and business partners. The Associate Director, SOX Compliance and Controls key area of responsibility include design of key controls (business processes, interfaces, and IT application controls), identification of audit process improvements, financial reporting risk mitigation, and remediation of control deficiencies. As part of this unique business structure, the SOX PMO group works closely with external auditors and Gilead Internal audit teams 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. Purpose The purpose of the Associate/Senior Associate/Principal Associate – MQO Portfolio...

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...

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. Preference for software-based regulatory experience or familiarity with software regulations and requirements. The Principal Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Diagnostics products and External Pacemaker to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval....

This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer I , you will assure new or modified products conform to requirements and establish compliance with the quality system. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. You will support new product development projects as...

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Our company's Animal Health Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry’s most innovative portfolios of products, services, and...

Associate QA What you will do In this vital role you will conduct routine checks, assist in quality audits, and support in implementing corrective actions based on QA findings Responsibilities General inspection of received shipments of raw materials, components, and labels Sampling of chemical raw materials and preparation of sample shipments Quality inspection and dimensional analysis for component and label batches Review of GMP shipment paperwork GMP controlled document review Initiation of deviation records What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek...

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 The Associate Director, Quality Control, will serve as site-based...

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 serve an extraordinary purpose. We make a difference...

Careers That Change Lives In this exciting role as a Post Market Quality Senior Engineering Manager, you will lead the Aortic Post Market Product Assurance and Quality Sustaining team based in Santa Rosa, CA for all commercial Aortic products for our Structural Heart and Aortic business. Manages a team of Reliability Engineers that are responsible for monitoring product performance, complaint investigations, and evaluating quality issues impacting released product Manage a team responsible for all Design Assurance activities supporting changes to commercial products. Coach team members through technical problem solving including CAPA investigations and triaging issues. Provide technical knowledge and...

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...

Position Overview Johnson & Johnson is hiring for a Senior Regulatory Affairs Specialist (Remote) – Shockwave to join our team. 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...

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. This position works out of our Columbus, Ohio plant location in the Abbott Nutrition Division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. The...

Our location in Santa Clara, CA currently has an on-site opportunity for a Senior Regulatory Affairs Manager - Transcatheter Mitral Valve Replacement within Abbott Ventures . This new team member is responsible for the management and leadership of Regulatory Affairs activities for an early stage Transcatheter Mitral Valve Replacement device. This individual will lead and coordinate global Regulatory Affairs activities including regulatory strategies, submissions to support clinical trial activities and product launches. The Senior Manager leads project submissions for regulatory approvals and acts independently to identify and resolve problems. This individual applies advanced regulatory expertise to guide cross-functional partners and...

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...

The Senior Director, GMP Operational Quality Assurance will be responsible for the oversight of Site Quality Operations for the Manufacturing of Cell & Gene products . The role will be responsible for leading the Quality on site operations team across multiple shifts for internal clinical and commercial manufacturing operations . Responsibilities include day- to-day operational quality oversight for internal batch record review, batch disposition and manufacturing operations across the end-to-end manufacturing processes for the manufacture of clinical and commercial intermediates and drug product batches. Responsibility includes ensuring all shift quality operational activities are completed in time by identifying technical risk...

The Senior Manager, Quality Assurance Contamination Control and Sterility Assurance is recognized as having expertise in the principals and application of sterility assurance and providing technical support for manufacturing of cell and gene therapy programs within cGMP manufacturing. This role will partner with stakeholders to define strategies for contamination control activities in key areas that include facility and equipment design and qualification (e.g. cleanroom, isolators, autoclaves, etc.), environmental qualification and monitoring programs, and operational practices (e.g. gowning, cleaning and sanitization, etc.). This individual will interface with internal manufacturing sites to support the maintenance of critical cGMP contamination control activities and...

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 works closely with cross-functional partners to ensure timely...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for the Analyst 1, Lab Quality Control role to be in Athens, GA. Benefits you will enjoy starting your first day Competitive pay based on experience, night shift differential, plus an annual...

This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. WHAT YOU’LL DO Provide Quality Engineering leadership in direct support of manufacturing. Management and development of Quality Engineers. Manage the activities of the Quality Engineering team. Provide Quality Engineering guidance and leadership to department and organization. Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations and applicable quality certification requirements. Aggressively identify and manage activities related to adding value to the organization...

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. Foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity, Collaboration, Innovation, Expertise. Are you ready to shape the future of Quality Audits? As Global Quality Auditor - Technology Audit &...

Medtronic is seeking a motivated and forward-thinking Quality Engineer with a primary focus i n the areas of mechanical, equipment, and tooling to join the team in North Haven, CT . This role is responsible for supporting manufacturing operations by ensuring quality processes and compliance with regulatory standards. The ideal candidate will have a strong foundation in mechanical /chemical engineering principles, problem-solving skills, and a commitment to continuous improvement. This role will support the Needles and PDBMF operating unit supporting products including V-Loc, Veriset Hemostatic patch, all absorbable and non-absorbable finished goods suture product lines. Key Responsibilities Support the development,...

This individual will be part of a corporate Global Trade Legal & Compliance team in the Global Operations and Supply Chain Legal Department composed of lawyers and compliance professionals that combine deep substantive expertise in global trade areas core to Medtronic’s business with in-house understanding of Medtronic’s businesses. Team members work across business units and geographies resulting in unique ability to 1) advise businesses on complex legal regulatory questions, 2) identify common and conflicting legal issues and positions across the company, and 3) contribute to high-level policy decision-making. The Sr. Compliance Manager, Global Trade Legal & Compliance will aid in...

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....

We are enhancing our US Oncology Office of Ethics and Compliance (OEC) team to deliver exceptional results and support our business growth. This is your opportunity to be part of AbbVie’s US Oncology Therapeutic Area (Oncology TA), which boasts multiple assets in commercialization and development, along with a mission-focused and inclusive culture. Your ideas and experience matter. We value driven individuals who thrive in a fast-paced environment, can lead initiatives from start to finish, see the promise before us, anticipate risks and opportunities, and are willing to learn and adapt to change. As the Associate Director, OEC, you will foster...

The Senior Manager, RA Global Regulatory Strategy, US & Canada position is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development within the Oncology TA. Assures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements. Additional Responsibilities...

AstraZeneca - Vaccines & Immune Therapies At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of people, where the burden of disease is greatest. During the COVID-19 pandemic, we played an important role as part of a truly global effort to respond to a new and unprecedented challenge. We will continue to advance science in vaccines and immune therapies and work with partners to drive improvements in public health and ensure our science reaches millions more people. Role The Senior Regulatory Affairs Director (SRAD) leads the global regulatory strategy for complex...

Sr. Cleaning Validation Engineer Job Responsibilities · Serve as the Cleaning Validation lead of cross functional team and able to provide guidance during planning, designing and development of projects. · Write and review technical documentation (cleaning cycle development reports, SOPs, system lifecycle documentation, protocols & reports for engineering and validation testing, cleaning validation master plans) · Creation, execution of Cleaning Validation Protocols, including identification and resolution of non-conformances/deviations. · Assist in preparation of regulatory submissions and presents validation in respective SME areas to regulatory authorities during regulatory inspections. · Manage contractors performing system qualifications, ensure the quality of completed deliverables....

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals . Senior Manager of Regulatory Project Management will plan, execute and oversee regulatory submissions and projects and manage cross-functional relationships to achieve on-time completion of submissions. This position will report to Head of Regulatory Affairs. Responsibilities Essential duties and...

Senior Manager Quality Control What you will do Let’s do this! Let’s change the world! In this vital role, you will lead the Amgen Thousand Oaks, Quality Control Microbiology Laboratories. This is a unique opportunity to learn about and support testing of Amgen products through various stages of the product lifecycle. The QC Senior Manager will report directly to the Director of Quality Control and as a member of the QC leadership team will contribute to fostering and further developing a culture of safety, quality and compliance. The QC Senior Manager will be accountable for the following functions in support...

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

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. About the Role The Director – Manufacturing & Quality, Training Globalization...

Senior Specialist Quality Assurance This position works out of our Alameda, CA location in the Diabetes Care division where 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. As the Senior Specialist Quality Assurance you will be responsible for interpreting applicable internal and external requirements and translate to produce documents such as procedures and partnership agreements that are inline with the Quality System. Define process improvements to ensure consistent implementation of internal requirements...

The Regulatory Labeling Senior Manager will be responsible for strategic labeling development of global labeling (CCDS, USPI, EU SmPC and other markets as necessary) on one or more mature marketed products. This role will also be responsible for developing relationship and managing work with a vendor who supports lifecycle product labeling. Key Duties and Responsibilities Reporting to the Global Labeling Strategy Team Lead, the GLL develops and maintains global product labeling for one or more products. This includes the company core datasheets (CCDS) and local labeling (Prescribing Information (PI) and Patient Information (PIL) for select markets (e.g., US, EU, UK,...

The Sr, Quality Engineer position works onsite of our Temecula, CA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. Lead on-time completion of Design Control Deliverables Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities Lead Risk Management activities from product Concept through Commercialization Lead...

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

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

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 The Global Quality Control - Deviation Mentor plays 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. At Lilly, we unite caring with discovery to make life better...

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

Our Company constructed a new manufacturing facility to significantly expand its production capacity for a medicine for the treatment of certain forms of bladder cancer. Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our Company’s longstanding commitment to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories....

Quality Program Manager - Supplier Quality Packaging (Global SQA) This position works out of our Columbus, OH location in the Nutrition Division . Key Areas of Responsibility/Team & Talent Development Lead and develop a team of five direct reports, fostering growth and excellence. Qualifications Oversee the qualification of new packaging, suppliers, supplier sites, molds, packaging formats, and replacement of supplier equipment and assets. Support Abbott Nutrition's pipeline of innovation and ongoing capacity and growth. Maintain a compliance and food safety-focused mindset, ensuring the team is always audit-ready. Continuous Improvement Drive strategy and vision for the Qualifications team, enhancing the...

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

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

Amgen is seeking a Regulatory Affairs Director supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this vital, product-facing role you will lead the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The purpose of Regulatory Affairs Director is To lead a team within Amgen’s Global Regulatory Affairs department To develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective...

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 Analyst Quality Control to be in San Angelo, TX. Job Summary Responsible for conducting complex test and analysis to assure that product comply with established specifications. Duties & Responsibilities Under general direction and in accordance with all applicable federal,...

J&J MedTech is recruiting for a Finished Goods Quality Assurance (FGQA) Supervisor , located in San Angelo, TX. 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 For more than 130 years, diversity,...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for a Quality Engineer to be in San Lorenzo or Manatí, Puerto Rico. The Quality Engineer reports to Quality Operations Lead, Quality Operations Leader or designee and with the objective of maintaining high quality standards for the product manufacturing process and the compliance with regulatory requirements, provides leadership, technical support and direction to Plant Operations...

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 Health Care

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...

In this exciting role as a Quality Systems Specialist – CAPA Specialist supporting the Tempe Campus - you will have responsibility for compliance to the Corrective and Preventive Action (CAPA) processes and Medical Device regulations and requirements, serve as a CAPA subject matter expert; provide guidance to CAPA owners and CAPA Board members to develop CAPA activities and conduct assessment of CAPA documentation. The Quality System CAPA Specialist will ensure compliance with Medtronic policies, FDA regulations, ISO 13485, and other requirements by rigorously assessing CAPA activities and documentation. They will participate in CAPA Board activities, provide guidance and mentorship on...

The Medtronic Grand Rapids site offers a Principal Quality Engineer level role in the Operations Quality group. This role is for an experienced engineer looking to make an impact on the site and positively affecting patient’s lives. This fast-paced role includes partnering with Operations, Manufacturing Engineering, Supplier Quality, Safety (and more) to drive improvements and risk reduction. The Grand Rapids site manufactures Cardiac Surgery devices sold across the globe. Come make a difference! Responsibilities may include the following and other duties may be assigned Collaborate with engineering and manufacturing functions to investigate and resolve quality or compliance issues discovered during...

The Quality Engineer I will have responsibility for ensuring quality within the Global Calibration Services, Midwest Region (GCSMR) department. GCSMR provides calibrations and support for test and measurement equipment used in facilities, research, development, and manufacturing environments in many business environments in the Midwest and throughout global Medtronic Responsibilities may include the following and other duties may be assigned. Develop, modify, apply and maintain quality standards and protocols for ensuring equipment is calibrated to specification. Collaborate with engineering, manufacturing, and vendors to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing and evaluating the...

This position is responsible for supporting activities related to the product/test development and software development and/or implementation of in-house and third-party software systems. The position will be a core member of projects, varying in complexity, to drive compliance with internal and external procedures and regulations. In this cross functional quality role, you will actively participate in product development and transfer activities, and internal quality initiatives, ensuring product and process conformance to CAP, CLIA and ISO 13485 standards. This role will serve as a resource to software development and product development to improve product quality, reliability, and process capability. This role...

Responsibilities Manage the document control program as well as suggest and implement improvements to existing processes. Analyze and process Change Requests (CRs) and Change Orders (COs) in Ensur. Write, edit, review, and maintain procedural documentation including, but not limited to, department policies, procedures, and guidance documentation at Illumina Laboratory Services (ILS). Perform document processing, distribution of controlled copies, and filing using manual and electronic systems per established procedures. Monitor change activities approval/implementation and resolve issues of varying complexity. Facilitate record management, including maintenance for retention periods. Ensure compliance with appropriate regulations. Onboard/offboard employees in the Ensur system. Provide training for...

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. Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi's Framingham Biologics facilities. QA's main responsibility is to ensure cGMPs are adhered to during manufacturing operations. Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety,...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. This position will support the lifecycle management of instrumentation within the Quality Control department at the Swiftwater, PA location while strictly adhering to Sanofi procedures, Health Authority Regulations, and cGMP's. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives....

At Sanofi, we’re committed to providing the next-gen healthcare that patients and customers need. It’s about harnessing data insights and leveraging AI responsibly to search deeper and solve sooner than ever before. Our team has released an FDA certified class II medical device titration application. We are gearing up for other software applications across the diabetes and speciality care journey, with external LMR partnerships. Join our Global Digital Team as a Digital Device Quality Engineering Lead. You will be responsible for the quality assurance efforts for our Software as Medical Device (SaMD) products, ensuring that they meet the highest standards...

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies 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. Abbott Vascular provides innovative, minimally invasive and cost-effective...

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...

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...

The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Animal Health Division can provide you with great development and a chance to see if we are the right company for your long-term goals Global Regulatory Affairs (GRA) Product Managers (PMs) are responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. GRA CMC PMs are also responsible for the preparation and review of information required for development of regulatory CMC dossiers for new and...

The Senior IT Quality Manager will elevate compliance and process excellence by ensuring adherence to regulatory requirements and corporate procedures. This role involves strategizing and implementing advanced quality system requirements, as well as leading high-impact, cross-functional initiatives to drive continuous improvement. Serving as an essential liaison between diverse business units and the BTS (Business Technology Solutions) Quality organizations, the Senior IT Quality Manager will establish and manage critical partnerships and contracts, ensuring alignment with business objectives and compliance standards. The ideal candidate will have a keen ability to influence stakeholders, leverage data for impactful decisions, and ensure operational excellence in...

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...

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

The Opportunity The Program Operations Compliance Manager will play a critical role on the HCO team at Genentech. This role is responsible for compliance review, decision-making, and limited approvals for funding operations (e.g., grants, exhibits, sponsorships, corporate memberships), Advisory Boards, and other areas of business operations as assigned, and ensuring full adherence to and oversight of applicable Genentech processes and guidelines. The role requires an individual with strong subject matter expertise on internal Genentech policies and state and federal laws specific to interactions with healthcare professionals, as well as an in-depth understanding of Genentech’s requirements, processes, and procedures. Serve as...

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 role involves supporting quality control and project management at the Pearl River site, ensuring compliance with regulatory standards for environmental and microbiological contamination control. This is a Monday to Friday, first shift position. We are an innovative global healthcare company with one purpose to chase the miracles of science...

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 YOU’LL DO The Quality Engineer is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. MAIN...

Sr. Hardware Design Quality Engineer Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. The position of Senior Design Quality Engineer is within our Infectious Disease Developed Markets business unit located in San Diego, California. In this role you will actively participate in product development and transfer activities, ensuring product and process conformance to FDA and ISO 13485 standards. This position will review validation methods and protocols, test methods, statistical...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Regulatory Affairs Specialist – Labeling & Operations supports regulatory compliance through the execution and oversight of regulatory labeling and regulatory operations activities. This role collaborates across functions to ensure product labeling meets global regulatory requirements and that...

Validation Engineer – Casa Grande, AZ Nutrition Plant As the Validation Engineer, you will ensure that change control and validation activities are executed in a timely manner while following all Abbott Nutrition Policies and Standards. This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get...

Cargo Quality Lead 60% Oficina – 40% Remoto Mitikah Tipo de contrato Indefinido Acerca de la posición Descripción Específica (Principales Responsabilidades) 1. Gestión del sistema documental Amplio conocimiento de la regulación, (NOM-059, NOM-073, Farmacopeas, Reglamento de Insumos para la Salud, Merck Index, etc). Asegurar el cumplimiento de regulación local e internacional vigente. Trabajar en la mejora continua de los procesos establecidos en la filial, dando soporte a las áreas GxP. Mantener un sistema de gestión de calidad que establezca las responsabilidades, procesos y principios de gestión de riesgos para las actividades reguladas en la filial. Implementar y actualizar políticas...

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

Senior Principal Software Development & Compliance Engineer Careers That Change Lives Transforming Patient Management with Smart Technology! Together, we can change healthcare worldwide. Cardiac Rhythm Management (CRM) Software develops the next generation medical technologies that alleviate pain, restore health and extend life for millions of patients across the world. We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. CRM Software is developed with state of the art, industry standard technologies and used by Clinicians...

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...

Lead Software Quality Engineer This position works out of our San Diego, CA location in the Rapid and Molecular Diagnostics, Infections Diseases business . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. As the Lead Software Quality Engineer, you’ll review documentation for accuracy, clarity, consistency, completeness, and compliance for multiple projects. Plans and performs assignments with a wide...

Senior Design Quality Engineer This position works out of our San Diego, CA location in the Rapid and Molecular Diagnostics, Infections Diseases business . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. As the Senior Design Quality Engineer , you’ll assure new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for...

We are searching for the best talent for Process Quality Specialist to be in San Lorenzo, PR! About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Key Responsibilities Leads investigations and rapid response teams (RRT) of the negative trends, quality/product process investigations & product complaints. Provides technical leadership towards the identification of the causes for non-conformances & process' failures, and implementation of the immediate, corrective & preventive actions. Reviews & analyses...

Senior CAPA Quality Engineer 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...

Manager, Computer System Validation Cell Therapy, Bristol-Myers Squibb Company, Summit, NJ. Develop, review, and approve protocols and associated reports while adhering to a change management process by drawing on experience with, MS Windows client and server technologies, standard networking principles and technologies, current good practices (cGXP) requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry, International Society for Pharmaceutical Engineering (ISPE) guidance, 21 CFR Part 11 compliance, identifying and documenting user and functional requirements, and executing equipment qualification documents. Support the execution of equipment qualifications and validation protocols; support calibration, equipment qualification and validation...

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

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

Nourish the world and your career as part of the Nutrition team 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®, Glucerna® – to help get the nutrients they need to live their healthiest life. WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer A fast-paced work environment where your safety is our priority...

– We are seeking a Regulatory Operations Specialist I for our St. Paul, MN Structural Heart team to perform specialized level work assignments and/or analyses, evaluation, preparation and general support of global regulatory activities . What You’ll Work On - Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives . Creates, reviews and approves engineering changes. Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines. Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those...

The Senior Specialist, Quality serves as a member of a team responsible for instituting consistent practices across the Durham facility in the disciplines of Deviation Management, Complaints, Corrective Action/Preventive Action Management, Annual Product Review Authoring, and Quality Council. The Senior Specialist, Quality Assurance will be primarily responsible leading the Deviation and CAPA management systems. The role is responsible for leading the local community of practice and representing Durham in the global communities of practice associated with the indicated quality systems. General Profile Monitor standard work within the assigned quality systems and implement improvements to adherence to compliance requirements Direct support...

Manager, Quality Engineering Cell Therapy, Bristol-Myers Squibb Company , Devens, MA . Provide quality oversight on computer system lifecycle documents, commissioning and qualification lifecycle documents, risk assessments and strategies. Review and approve validation plan, qualification plan, data migration plan, data integrity risk assessment and Electronic Records & Electronic Signatures (ERES) Assessment in compliance with Food and Drug Act (FDA) regulations and company policies. Review and approve system risk assessment documents and ensure all mitigation strategies are developed and implemented for potential risks. Review and approve requirement specifications in validating new or modified processes, systems that supports manufacturing in the plant...

Executes the Clinical Quality and Evidence Generation strategy through strong data analytic support, employing experience in Quality Improvement and biostatistics to support business objectives of the Clinical Quality program, development of evidentiary claims using real world evidence, and data visualizations and reports to surface insights to decision makers to improve population health through our products. Responsibilities Creates effective communication methods with XFN stakeholders to share and interpret data by building reports and dashboards to surface insights and support decision making. Participates in QI projects from initiation to completion, analyzing results and developing narratives about the effectiveness of the project to...

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 Senior Quality Engineer drives new product development/life-cycle management design control activities by leading all cGMP compliance activities on assigned projects/products. This includes compliance with relevant Sanofi policies and procedures, domestic and international regulations, standards and guidelines and customer requirements. The Senior Quality Engineer ensures application of quality engineering and...

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...

We are searching for the best talent for a Regulatory Affairs Specialist to be located in Cincinnati, OH or Raritan, NJ. This role will work a Flex/Hybrid schedule with 3 days per week in office. There is NO remote option. Purpose The Regulatory Affairs Specialist provides regulatory guidance to project teams in strategic planning and related submissions to support Ethicon Endo Surgery (EES) products. Under minimal supervision, the individual develops and executes regulatory strategy for significant change supplements and 510(k) registrations to support continued commercialization of products in key countries. The Specialist helps to define data and information needed...

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...

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

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. Lead and supervise QC Laboratories to ensure the implementation and sustainability...

Executive Director of Regulatory Affairs Live What you will do In this vital role as Executive Director of Regulatory Affairs, you will direct regulatory affairs activities within an assigned disease area, ensuring compliance with applicable laws and regulations. You will also provide strategic direction and leadership to the regulatory affairs team. The Executive Director of Regulatory Affairs is a product facing role that leads a designated part of the Inflammation and Rare Disease Global Regulatory Therapeutic Area in the Global Regulatory Affairs organization. This role will report into the Vice President, Global Regulatory Affairs Responsibilities Provide management and leadership...

Objective / Purpose Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities...

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. Shift 2nd (1400 - 2200) Responsibilities The Senior Technician – QC...

Join our Leadership Team as the US Regional Project Quality Lead! The Quality Lead builds and maintains strong relationships with the relevant cross functional teams for capital projects, supporting the coordination and alignment of individual Quality activities impacting Quality Operations. The Lead is responsible for the quality aspects of equipment and facility commissioning and qualification, and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations, employing Quality Risk Management principles. The Lead will manage our Quality teams through end-to end support, from siting decision through Quality...

This position works out of our Columbus, OH location in the Nutrition Division. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Protality® and Glucerna®– to help get the nutrients they need to live their healthiest life. The Opportunity Abbott Nutrition Supply Chain’s (ANSC) QA organization is responsible for quality and compliance of Abbott Nutrition (AN) manufacturing and products. This position will lead medium to large scale...

This position works out of our Abbott Park, IL location. What You’ll Work On Abbott is currently seeking an experienced professional to provide Provides direct oversight for moderately complex elements of Abbott’s compliance program at the Divisional level for Abbott Nutrition International (“ANI”). Responsible for development and implementation of divisional monitoring plan. Responsible for managing monitoring for ANI. Identifies compliance risk areas and recommends action plans to ECO or direct management. Responsible for direct compliance support of key business activities for ANI. Responsible for direct compliance support to ANI sales teams, marketing teams, research and development organization, medical teams, and...

Regulatory Strategist - VIE Contract Location United States of America, Morristown Target start date 01/09/2025 iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28. PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship. PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure...

Johnson & Johnson is hiring for a Sr. Manager, Regulatory Compliance - Shockwave Medical 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...

The Senior IT Quality Manager will elevate compliance and process excellence by ensuring adherence to regulatory requirements and corporate procedures. This role involves strategizing and implementing advanced quality system requirements, as well as leading high-impact, cross-functional initiatives to drive continuous improvement. Serving as an essential liaison between diverse business units and the BTS (Business Technology Solutions) Quality organizations, the Senior IT Quality Manager will establish and manage critical partnerships and contracts, ensuring alignment with business objectives and compliance standards. The ideal candidate will have a keen ability to influence stakeholders, leverage data for impactful decisions, and ensure operational excellence in...

POSITION SUMMARY The Lead Software Quality Engineer is responsible for complete end-to-end verification of Natera software systems and services using both manual and automated test strategies. PRIMARY RESPONSIBILITIES Perform software verification, define and execute test cases and scenarios required for software quality assurance and regulatory compliance. Perform system analysis, assess risk, and develop strong test strategies by analyzing product design and technical specifications, and by collaborating with product managers and developers. Participate in building and maintaining data-driven test automation framework using automation tools and libraries. Perform debugging and root cause analysis of product issues or defects. Evangelizenew testing methodologies, best...

Sr. Associate Warehouse Quality Systems What you will do Let’s do this! Let’s change the world! In this vital role you will be part of the Supply Chain team, and you will participate in multiple cross-functional initiatives for Amgen North Carolina (ANC) warehouse. You will serve as warehouse Subject Matter Expert and as site representative on various cross-functional task forces and teams to ensure that consistent and well-integrated practices are developed throughout the organization. The focus of the Sr. Associate is to own and manage warehouse quality systems records, including deviations, change control records, CAPA records, documentation and training, as...

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

Essential Job Duties and Responsibilities The VP, Innovative Medicine Regulatory Compliance position reports into the VP of J&J Regulatory Compliance. This role oversees all aspects of regulatory compliance within Innovative Medicine, ensuring the company's adherence to all applicable regulations, managing internal audits and maintaining a high state of readiness for regulatory inspections. This involves developing and implementing strategic compliance plans, managing regulatory interactions, and building a robust compliance culture within the organization. The position requires extensive communication with key stakeholders, health authorities, suppliers and other functional leaders. This role will provide executive leadership for compliance teams including internal audits. The...

Johnson & Johnson is currently recruiting for a Lead, Technology Compliance! This position can be located in Raritan, NJ, Horsham, PA or Tampa, FL. 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 currently recruiting for a Senior Analyst, Technology Compliance! This position can be located in Raritan, NJ, Horsham, PA or Tampa, FL. 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...

Johnson & Johnson is currently recruiting for a Lead, Technology Compliance! This position can be located at any J&J Innovative Medicine site, with a preference for Raritan, NJ. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) North America- Requisition #R-012327 Beerse Belgium– Requisition#R-013806 Remember, whether you apply to one or all of these requisition numbers, your applications will be...

Johnson & Johnson is currently recruiting for a Director, Technology Compliance! This position can be located at any J&J Innovative Medicine site, with a preference for Raritan, NJ. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) North America- Requisition #R-012331 Beerse Belgium– Requisition #R-013811 Remember, whether you apply to one or all of these requisition numbers, your applications will...

As a member of Supplier Quality Engineering at the Cardiac Surgery Brooklyn Park facility, you will be responsible for management of external suppliers who are integral with the life-saving cardiovascular devices produced at our site. You will lead oversight of supplied products managing supplier relationships, changes, and improvements while ensuring conformance to purchased material requirements and managing nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, regulatory bodies, international requirements, and Quality System Regulations. Our Cardiovascular Surgery Unit offers devices and therapies that treat patients with compromised oxygen levels during critical, life-saving surgery. As a member of our team,...

We are currently looking for a Senior Program Manager - Quality and Regulatory to join our Program Management Office (PMO) within our Ear, Nose, and Throat (ENT) Operating Unit (OU). In this exciting role as a Senior Program Manage r, you will engage with multiple Product Development teams within the ENT OU. You will manage projects that are strategic to the business and work cross functionally with various functional managers while driving program execution. Also, this role will engage with the OU leaders through steering meetings, monthly leadership meetings and daily project execution. The ideal candidate can work a hybrid...

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. Quality Assurance (QA) is responsible for quality oversight of operations at Sanofi MA BioCampus facilities. QA’s main responsibility is to ensure adherence to cGMPs during manufacturing operations through partnership with the site and direct engagement with daily operations activities. The QA Process-Centric Unit (PCU) is a team that is responsible...

Position The Specialist - Quality Control, within Laboratory Operations, under the broad direction from the Associate Director – Quality Control (Equipment Support), will be responsible for the implementation and management of laboratory equipment and automated systems utilized within assigned laboratories. The incumbent assures operation in accordance with our Manufacturing Division and Company safety policies and procedures, current Good Manufacturing Practices (cGMP) regulations, and within the departmental budget. Responsibilities can include providing technical expertise and recommendations on Company, Divisional and Organizational projects such as capital requests, operational improvements, instrument repair, and run the business activities in support of all testing...

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

The Director of Government Pricing and Compliance - Vaccines drives the Government Pricing Calculations for all government contracts for the US vaccine business unit to ensure business practices and activities are compliant with regulations, Sanofi guidelines and legislative requirements. They must be up-to-date on all changes to government pricing calculations proposed by the federal government and provide oversight and guidance to the broader Market Access team, particularly Strategic Pricing and Government Contracts as well as senior management. The candidate must be able to employ practical assumptions and historical performance to offer predictive analytics on impacts to government pricing calculations due...

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

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

The Sr. Compliance & Ethics Specialist will be a valued member of the Ethics & Compliance Team responsible for implementing the Company's Ethics & Compliance Program. The position will have a wide-range of responsibilities necessary for the execution of an effective compliance program, including field and desk monitoring, internal investigations, training, communications, spend transparency, and special projects. The role is located at Neurocrine’s San Diego headquarters. Position requires up to 40% travel. This position resides in the Legal department. _ Your Contributions (include, but are not limited to) Provide sound compliance guidance consistent with applicable laws, regulations and Neurocrine policies...

Regulatory Affairs Specialist II The position of Regulatory Specialist II is within our Toxicology business. In this role, you will work as part of the Regulatory Affairs department with direct responsibility for the preparation of documentation for domestic and/ or international product registrations for new and modified products, regulatory assessment of product changes, review and approval of labeling and advertising/promotional materials, approval of global product distribution, and maintenance of regulatory records and files. What You’ll Work On Provides extended regulatory support for diagnostic product and commercial diagnostic products Assists in developing regulatory strategies for products in county introduction, registration...

This position is an individual contributor role in the GRACS Regulatory CMC and Quality Team. The primary role for this position is to act as Lead System Owner of the Medical Device and Combination Product (MDCP) Design Controls IT solution JANUS with Quality oversight responsibility for all SDLC activities and requirements. JANUS is a COTS software solution hosted within our company Managed Cloud (MMC). JANUS provides a digital information management solution for the MDCP Design Controls and Risk Management (DCRM) process. JANUS is an enterprise system and classified as Good Automation Manufacturing Practices (GAMP) Category 4. This role includes but...

About the role The Quality Control Scheduler will be responsible for developing and maintaining the Quality Control schedule for the analytical and microbiology laboratories. The candidate will be responsible for the Quality Control schedule including providing windows for non routine activities and coordinating training-related activities, as well as evaluating capacity analysis and continuous improvement opportunities. The current work schedule for this position is day shift M-F (8 hrs). The candidate will need to be flexible to support company holidays and shutdown scheduling coverage based on business needs. How you will contribute Independently create and maintain schedules for Quality Control using...

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

Job Summary We are seeking a Director, Quality Assurance, to join our Clinical Quality Assurance (CQA) organization. The person will provide leadership for the team responsible for providing quality oversight in collaborating with required functional areas in ensuring compliance with applicable Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), and Good Pharmacovigilance Practices (GVP) regulations. This position reports directly to the Vice President, Global Quality Systems and Compliance. Essential Functions Ensure the implementation and/or maintenance of global, phase-appropriate clinical Quality Management System (QMS) policies and procedures to ensure compliance to applicable regulations, including U.S. and EU. Provide quality oversight...

Director Supplier Quality The Opportunity Abbott Diabetes Care has an opportunity for a Director Supplier Quality. The Director leads strategy, management and support for global supplier quality associated with the division. Areas include suppliers (parts and services), Third Party Manufacturers (TPM), and Original Equipment Manufacturers (OEM), service providers and consultants. Establishes quality systems and plans for supplier controls to assure design, development and manufacture of the highest quality products to exceed customer requirements. Interfaces with outside regulatory agencies. What You’ll Work On Champions quality and compliance through awareness of requirements, trends and other external influencing factors especially in the area...

Position This role will primarily support Manufacturing Operations and will serve as the primary Quality Assurance Representative for the Downstream (Blend, Fill and Lyophilization) Integrated Production Team (IPT). This team member will provide guidance from a quality compliance perspective having knowledge of local and global Animal Health standards, USDA regulations, and cGMPs. This position will serve as the Quality Point of Contact for any quality issues the Downstream IPT has. Additionally, this role will serve as the Quality Assurance Representative on Downstream Quality Systems Records. These records include Deviations, Change Controls, SOP updates, Batch Record updates and more. This...

Johnson & Johnson is recruiting for a Director, Design Quality Engineering in Heart Recovery located in Danvers, MA with considerations given to other J&J MedTech site locations in the US. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact...

Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Process Quality Leader to be located in San Angelo, TX. 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 Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Position The QA Compliance – CSV and DI role is...

The Associate Quality Director conducts quality assurance oversight and management activities of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols and Vertex policies and procedures. These activities include the development and execution of study level audit plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, monitoring quality issues and compliance metrics, investigation and CAPA management, and proactive inspection readiness activities. This role is located at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210. This is a second shift role from Wednesday...

The Principal Regulatory Affairs Specialist will have a role in supporting product teams for new/updated Class I, II, and III devices across 2 operating units with varying products and business needs. Collaboration with cross function teams (e.g., R&D, Clinical, Quality, Marketing, etc.) to ensure global requirements and strategies are incorporated into the project documentation will be a key deliverable for this role and will be measured by submission ready outputs for inclusion in global submissions. Additionally, this role will support the Total Product Lifecyle (TPLC) for capital equipment, disposable/sterile surgical tools, and CSF/critical care related devices across the cranial and...

For over a decade, Medtronic has been at the forefront of transforming stroke care, leading the fight against both acute ischemic stroke (AIS) and hemorrhagic stroke. By equipping physicians with innovative technologies, we empower their expertise to improve patient outcomes and redefine neurovascular care. Our commitment extends beyond medical device development—we actively collaborate with the medical community to drive meaningful advancements in stroke treatment. Together, we are changing the way stroke is managed worldwide, making a lasting difference for the millions of patients affected every day. Click here to learn more about Medtronic Neurovascular brain treatments and therapies. #Neuroscience Join...

Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs 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. 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 are an innovative global healthcare company with one...

As the Americas Regional Quality Head, you are accountable to maintain an effective management oversight on LOC Quality through having in place an effective QMS and a competent LOC Quality team to support GSK Supply Chain and Commercial business. Strong leadership and knowledge are required to develop LOC quality leaders to be highly effective in making quality and business critical decision, including building strong relationships with the external authorities (including FDA, Public Health Agency of Canada, ANVISA), and internal partners GSK commercial organization and GSK regulatory affairs organization. This position is to provide leadership and management support to the America...

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. T he Associate Director, Computer Systems Validation (CSV), Equipment Commissioning & Qualification (ECQ) supports the activities and personnel associated with design,...

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

POSITION SUMMARY At Natera, we revolutionize the world of medicine by developing genetics products that combine cutting-edge technology and science. On top of that we want to accelerate the breakthroughs in research to improve care by offering our unique genomic and clinical data. In order to achieve that we are looking for a Software Quality Engineer who has experience in testing data products to join the team. The ideal candidate for this position would want to help develop software that lasts -- extensible, testable and self-documenting. No biology background is required but this is an excellent opportunity for a strong...

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

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

Introduction to role Are you ready to lead the charge in strategic communication excellence? As part of the Clinical Regulatory Writing team, you'll be at the forefront of crafting pivotal clinical-regulatory documents that align with project strategies and regulatory requirements. Our mission is to support core therapeutic areas throughout all phases of clinical development, ensuring successful submissions and approvals. Join us in driving communication leadership and making a tangible impact on drug projects! Accountabilities Independently manage clinical regulatory writing activities across a portfolio of work. Author clinical-regulatory documents within a program, ensuring adherence to regulatory, technical, and quality standards. Provide...

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

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

– We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management team in Sylmar CA. As an individual contributor , the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific , regulatory and business issues to enable products that are developed , manufactured or distributed to meet required legislation . The individual has department / group / site level influence and is generally recognized as an expert resource within the department . The individual may share knowledge and expertise with others in support of team activities . The individual may identify data...

We are seeking an experienced Senior Development Quality Engineer to join our Structural Heart team at our Menlo Park, CA location. The individual in this position will assure new or modified products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will support new product development projects as well as support sustainability of commercially released product. This position may also support manufacturing processes to meet daily production schedules while enhancing productivity...

About the role This position supports site projects, technical transfers, and ongoing validation maintenance. Primarily 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 Data Integrity Assessment This position is responsible to maintain validation documentation aligned with Good Documentation Practices (GDP) and ensure compliance with industry standards (e.g. FDA, EU GMP, ISO, etc) Provides technical subject matter expert...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio . This is accomplished through leadership of product-specific Global Regulatory Teams (GRTs) and representing the...

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