Quality & Regulatory Jobs in Pharma & Biotech

Quality Control Manager Location Virginia, Brisbane About the job Ready to push the limits of what’s possible? Join Opella in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions of consumers around the world. As Quality Control Manager within our Quality Team you’ll lead a team of 5 x Direct Reports and be responsible for coordinating and managing the analytical and microbiological testing of starting materials, intermediate bulk and finished products to approve or reject starting materials. You will also oversee vendor...

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...

Beam is seeking a highly talented and motivated Director to join our Compliance and Quality Systems team. The Director will be responsible for supporting Inspection readiness, Supplier Qualification including oversight of audits, and Compliance including deviations, change controls and CAPAs. This role oversees the Quality Management System (QMS) for Beam Therapeutics internal and external operations, specifically partnering with Veeva, external auditing partners, and external suppliers. This role will support cross-functional operations to ensure that systems and processes are compliant with GxP compliance areas (GLP, GCP, GMP, GDP, GVP) as the programs move from clinical to the commercial phase. This role...

Medtronic – Milwaukee, WI manufactures spinal implants and Brain/ENT instrument components. In this exciting and fulfilling role the Quality Engineer will be responsible for providing quality support to the product value stream, ensuring that customer and patient needs are met every day. They will be part of a passionate team dedicated to ensuring our products meet the highest standards. The Senior Quality Engineer is involved in developing, modifying, and maintaining quality standards for processing materials into finished products. The role collaborates with engineering and manufacturing to ensure quality standards, devises inspection methods, conducts quality assurance tests, and performs statistical analysis...

The Senior Engineering Manager - AME and Program Support Quality will lead a team of talented engineers at our Twin Cities Campus manufacturing sites (Rice Creek, Brooklyn Park, Plymouth-Annapolis, Plymouth-Cheshire). This role is pivotal in driving new product introductions and supporting significant projects across multiple sites. The Senior Engineering Manager will play a key role in mentoring and coaching engineers, ensuring successful project execution, and contributing to the Quality Leadership team. Responsibilities may include the following and other duties may be assigned. Lead and manage AME engineers focused on New Product Introductions, developing and commercializing manufacturing processes for combination products....

Medtronic – Milwaukee, WI manufactures spinal implants and Brain/ENT instrument components. In this exciting and fulfilling role the Quality Engineer will be responsible for providing quality support to the product value stream, ensuring that customer and patient needs are met every day. They will be part of a passionate team dedicated to ensuring our products meet the highest standards. The Senior Quality Engineer is involved in developing, modifying, and maintaining quality standards for processing materials into finished products. The role collaborates with engineering and manufacturing to ensure quality standards, devises inspection methods, conducts quality assurance tests, and performs statistical analysis...

Medtronic, Warsaw, also known as Warsaw Orthopedics, manufactures Spinal Implants and Brain/ENT components. As a member of Supplier Quality Engineering at Medtronic, Warsaw, you will be responsible for management of external suppliers to Medtronic, Warsaw. You will lead oversight of supplied products, ensuring conformance to purchased material requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations. Together with our customers, we are moving spine and cranial surgery from an art to a science. Responsibilities may include the following and other duties may be assigned. Ensure that suppliers...

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 Software Quality that changes lives. Responsibilities may include the following and other duties may be assigned. Plans, directs and implements all aspects of...

Medtronic – Milwaukee, WI manufactures spinal implants and Brain/ENT instrument components. In this exciting and fulfilling role the Quality Engineer will be responsible for providing quality support to the product value stream, ensuring that customer and patient needs are met every day. They will be part of a passionate team dedicated to ensuring our products meet the highest standards. In this role, the Quality Engineer II is critical in supporting key department metrics, which contributes to the global strategy while delivering on our mission to manufacture products of the highest quality that alleviate pain, restore health and extend the life...

The Regulatory Labeling Associate Director will be responsible for strategic development of global labeling (CCDS, USPI, EU SmPC and other markets as necessary) on one or more marketed products. This role may also be responsible for the development and management of a TLP with some guidance. Key Duties and Responsibilities Ensures compliance with labeling governance requirements and associated business processes. Leads label working groups and represents labeling at senior labeling governance meetings. 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)...

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 of the Operational Excellence (OpEx) team is to drive industrial performance to achieve the site’s strategy and ambition. The OpEx team brings a high level of expertise and leadership in Sanofi Manufacturing System (SMS) methodology, transformation and change management. OpEx teams collaborate with all functions at the site,...

In this vital role you will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. Assist U.S. Regulatory Lead to support regional regulatory activities Provide and maintain IND/BLA documentation support (e.g. annual reports, amendments) in collaboration with U.S. Regulatory Lead Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications Review regional component of the Global Regulatory Plan and provide input to operational deliverables Ensure compliance with submissions to regulatory agencies Support U.S. Regulatory Lead in...

Job Title Supplier Quality Manager Our location in San Diego, CA currently has an opportunity for a Supplier Quality Manager within our Cardiometabolic & Informatics business unit. This role will be responsible for providing technical and quality support for supplier selection, qualification, and approval. There will be responsible for ensuring that the supplier audit program is implemented in compliance with existing procedure requirements including audit schedule and execution, supplier auditor qualifications, adequacy of audit reports, and on-time closure of audit non-conformances. What You’ll Work On Manages a group of individuals who have responsibilities in the selection, qualification, and ongoing...

Our location in Lake Forest, North Chicago, IL currently has an opportunity for a Associate Director Validation position. This person will be Responsible for applying clinical best practices, regulations, and quality standards for successful planning and execution across different programs within Clinical Affairs. This individual is responsible for executing in-vitro diagnostic studies in support of product submissions and Laboratory Developed Tests. Clinical studies may include but are not limited to specimen collection, product testing, and usability. The Associate Director Clinical Research will have direct reporting of Clinical Research Associates and Clinical Study Assistants. Required to manage multiple projects simultaneously and...

The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing globalstrategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product....

The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing globalstrategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product....

The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing globalstrategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product....

Position The Director, Regulatory CMC will be responsible for overseeing the development and execution of regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) aspects of our pharmaceutical products. The ideal candidate will have a deep understanding of regulatory requirements and guidelines related to CMC aspects of pharmaceutical products, as well as experience leading regulatory affairs activities for a biotech or pharmaceutical company. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies...

Legend Biotech is seeking a Quality Assurance Operations Manager as part of the Quality team based in Somerset, NJ. Role Overview The Quality Assurance Operations Manager is an exempt level position with responsibilities for providing quality oversight over the production of personalized cell therapy to support clinical requirements in a sterile GMP environment. This role includes supervision of the Quality Assurance Shop Floor personnel as well as working with manufacturing to troubleshoot issues. Key Responsibilities Read, interpret, and revise documents such as SOPs and Work Instructions. Develop a positive relationship with Quality Assurance, Quality Control, Information Technology, Engineering and...

The Quality Specialist participates the day to day management and operations of the facility, products and vendors. Through outstanding communication, effective problem solving, and active management of ambiguous situations, the Quality Specialist 3 ensures safety, quality and compliance with all relevant procedures, state and federal regulations and customer expectations. Ensures smooth and safe operations of the storage facility through stakeholder and vendor engagement. PRIMARY RESPONSIBILITIES Oversight and Ownership of a Quality System (e.g. Change Control Lead including system and board lead) Collecting and trending quality metrics Assistance and leadership in CCRS, CAPAs, Deviations, SCAR, Complaints, and NCRs and filing completed...

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...

Our Quality Organization ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Under the direction of the Associate Director of Quality Control Laboratories, the QC Lab Manager is responsible for providing guidance and supervision to QC Specialists and Technicians to complete testing and testing support...

The Associate Director, Therapeutic Area Audit Strategy Lead will be mainly responsible for developing the TA audit strategy and overseeing the planning, conduct and reporting of internal and external audits of clinical trial investigator sites. Key Responsibilities Design , develop and implement the Clinical Audit Strategy for various Therapy Areas (ICN & HOCT) . Oversee the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and process/systems, including for- cause and directed activities. Provide input in the global audit plans based on identified signals/trends/risks/gaps . Partner with R isk, G overnance, O perations (RGO)...

Purpose and Scope The primary focus of the Associate I, Quality Control (QC) role will be to perform GMP testing to support product release and in-process testing. This role will also provide technical support and troubleshooting for analytical or microbiological tests. This is for a Sun-Wed 6AM to 430PM Shift Knowledge, Skills, and Abilities Education Bachelor’s Degree or equivalent combination of education and experience Experience 0-2+ years of regulated industry experience or equivalent combination of education and experience Responsibility Perform GMP lot release and in-process testing for analytical and/or microbiological test methods and perform data analysis using various electronic instruments...

GSK is currently looking for a Validation Engineer to join our team in Upper Merion, PA. In this role, you will be responsible for equipment/facility validation projects in a hands-on role including writing validation protocols, scheduling and executing testing, gathering and analyzing data and writing validation summary reports. This person will participate as a supporting member representing validation on project teams. Validation Engineers will lead specific validation projects. KEY RESPONSIBILITIES Design required validation studies and write protocols for the facility and equipment. Coordinate resources required to complete validation studies in a timely manner. Execute validation studies per required schedules in...

This role is based out of Liberty, South Carolina. Responsible for general supervision of the manufacturing inspection and test functions at every stage of the manufacturing process. May supervise inspection and test activities of operators. Performs function failure testing as well as physical defects. What You Will Work On Oversees operational implementation of quality assurance strategies and regulations. Completes the assessment of potential risks, ensures compliance and gives recommendations to management. Supervises team to ensure quality control aspects of the process are met (labouratories studies, clinical research, testing, operations, raw materials, production, finished product or services). Facilitates audits and regulatory...

Regulatory Affairs Specialist The Regulatory Affairs Specialist works out of our Irving, TX or Abbott Park, IL location in the Transfusion Medicine Business. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. What You’ll Work On Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team. Supports necessary regulatory activities required for product market entry and on-market support of instrument hardware and software. Work with Regulatory...

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve. Provide leadership and direction for Quality Risk Management (QRM)...

Staff Operations Quality Engineer provides quality assurance support for all aspects of manufacturing operations, including process quality, QC testing, inspections (incoming, in-process and final), validations, supplier quality, DMR/DHR creation and maintenance and various QMS activities through the operations lifecycle. Furthermore, this role focuses on establishing strategies for quality engineering, inspection & testing, suppliers and supply chain activities to achieve operational excellence. The role collaborates and builds relationships with cross-functional stakeholders such as Laboratory Operations, Supply Chain, Supplier Quality, Equipment, Facilities, EH&S, Quality Assurance, Quality Control and QMS teams to develop ideas and use cases and industry best practices in the...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Quality Business Owner within our Quality Systems Team will be to own process, system and data. Establish and prioritize process evolutions for the site. Support audit and inspection, and present the process to auditors and inspectors. Proactively identify remediation actions from findings during internal and external audits,...

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 Quality Assurance Department is responsible for providing oversight on all GMP activities and related functions associated with the manufacture and release of biological products at the site. The department manages the regulatory site program for the Framingham Biologics, Framingham Biosurgery and Northborough sites (e.g. Dossier Compliance, Dossier submission reivew)...

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 Quality Assurance Department is responsible for providing oversight on all GMP activities and related functions associated with the manufacture and release of biological products at the site. The department manages the compliance program for the Framingham Biologics, Framingham Biosurgery and Northborough sites (e.g. Self Inspection, Dossier Compliance, External Inspections)...

The Associate Director, Facilities & Engineering Operations Quality Assurance is responsible for providing quality support and oversight for Facilities Operations and Engineering programs at Vertex Cell and Genetics Therapies sites. These include the Facility and Equipment Preventive Maintenance and Calibration program, and facility control programs such as Critical Alarm Management, and Pest Controls programs. This roll serves as a trusted advisor to the site operation business partners and provides compliance guidance, collaboratively working with the business partners to gain a better understanding of their needs and facilitate resolution of quality issues in a timely manner. This role will report to...

The Quality Operations Sr. Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. Quality Operations Sr. Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. This role reports to the first shift Sr. Manager, GMP Quality - Cell & Gene This role is located at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210 This role is 1st shift 700am-530pm Sunday to Wednesday Key Duties & Responsibilities As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Vertex Cell and...

The GMP Operational Quality Manage r is an advanced technical resource in the principles and application of quality assurance and compliance. The Quality Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. The Quality Manager adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. This hybrid position is based onsite at our Boston Seaport HQ (3 days onsite and 2 days flexible). Key Duties and Responsibilities The responsibilities of this position may include, but are not limited to, the...

The Associate Director in Materials Management is responsible for quality oversight of all materials used in drug product manufacturing, and associated materials management controls to meet cGMP requirements. This includes providing quality oversight to inventory management, and consumption controls to assure accurate lot genealogy and traceability throughout the drug product manufacture. The role is also responsible for the development and maintenance of relationships with the external material and manufacturing vendors, to drive compliance, monitor performance and support continuous improvement activities. The quality role will closely partner with operational stakeholders and participate in associated governance for the successful planning and execution...

The Vertex Internship Program offers students the opportunity to learn about the pharmaceutical industry from a hands-on perspective. You will be working closely with and learning from some of the brightest people in the industry. When you join our internship program you should not be surprised to see that our environment is one that is innovative and team oriented, where collaboration is not just a word, and "we are relentless" is in everything we do. Students can expect to be challenged by their project plan, connect with other interns, and feel valued by the Vertex community. Not only will interns...

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. The position provides Quality Assurance oversight for Quality Control (QC). Provide QA (Quality Assurance) review and approval of Quality method validation / QC equipment qualification, QC protocol, reports, QC process control document, new and existing procedures, and Quality Control deviation/investigations. Leads triage using trend activities....

Create or develop engineering study, developmental and performance qualification protocols for validation or requalification studies. Create or develop final reports of completed for validation or requalification studies. Planning and overall completion of scheduled validation/requalification activities Execution of temperature mapping and sterilization related requalification activities independently including set-up of temperature sensors and biological samples for qualification. Perform data analysis independently for all executed requalification and generate results Place data in proper scientific context by consulting and citing relevant literature. Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance,...

About the role Plan and Develop improvement and compliance projects relating to the QC Microbiology department. Responsible for basic project management and documentation authoring (e.g. change controls, protocols, reports, and regulatory submissions). Provide technical knowledge and support investigation teams for QC Microbiology related systems and test methods. Self-led individual that works under only very general management. You will report to the Head of Quality Control Labs How you will contribute Lead projects across all shifts for the QC Microbiology department, including indirect management of assigned personnel when supporting these activities. Communicate with departments and influence decision-making to support QC Microbiology...

At Amgen, you’ll find a culture of collaboration, creativity, and commitment to excellence. Our values are grounded in respect for our people, patients, and the communities we serve. What you will do Ready to make an impact? Join us in redefining the world through innovation! We are offering multiple co-op opportunities starting in late June 2025. As a co-op, you'll collaborate with cross-functional teams, gaining hands-on experience and advancing your professional skills. You’ll work on meaningful projects and initiatives within the manufacturing industry, contributing to the team’s success while developing your own potential. Measure and analyze current system and process...

In this exciting role as a Senior Compliance/Audit Specialist, you will be responsible for ensuring compliance with regulatory requirements and internal policies at Medtronic’s North Haven, CT, manufacturing site. You will play a key role in maintaining quality and regulatory standards by facilitating and preparing for audits, assessing risks, and driving continuous improvement initiatives within the Quality Management System. Written in 1960, Medtronic's Mission dictates that our first and foremost priority is to contribute to human welfare. Over a half-century later, the Mission continues to serve as our ethical framework and inspirational goal for our employees around the world. The...

Your skills could be critical in helping our teams accelerate progress. In this role, you will be responsible for the oversight of regulatory review of advertising, promotion, medical, media relations and other internal and external communications related to company products in one or more therapeutic areas. You will play an important role in mentoring and developing direct reports for future leadership roles. You will also provide input into the global organization for promotional strategies, including launch strategies. Additionally, you will be the p rimary therapeutic area liaison with FDA’s Office of Prescription Drug Promotion (OPDP) for drugs, Advertising & Promotional...

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

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. This role reports to the Senior Director, Quality and Regulatory, EM-NA and is part of team that has primary responsibility for providing Quality oversight for 3rd Party Manufacturing (Contract Manufacturing Operations) to oversee activities of QA/QC and compliance functions to ensure compliance with current Good Manufacturing Practices (cGMPs). This position...

Your skills could be critical in helping our teams accelerate progress. In at least one product area, you will be considered the resident expert in Global Regulatory Affairs Region NA, Advertising & Promotion (A&P) group on promotional, labeling, product defense, and development strategies. You will be responsible for decision-making, direction, and oversight of the day-to-day activities of assigned products, departmental activities, and direct reports in order to meet internal and external customer needs. 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...

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 External Manufacturing and Supply (EM&S) Large Molecule Specialty Care organization is responsible for all Contract Manufacturing Organizations (CMOs) across the Specialty Care GBU that deliver Sanofi products. We serve the GBUs within M&S with drug substances, drug products, and finished goods, aiming to develop into a best-in-class organization that...

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. Join our Quality Assurance (QA) Operations team at Sanofi’s Framingham Biologics facilities! We ensure cGMP compliance during manufacturing to guarantee the safety, quality, and efficacy of our products. As the QA Principal Team Lead, you’ll provide quality support and direction to Manufacturing, Quality Control, and support functions. You’ll lead the...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distributing of products through formal QA Audits, investigations, training, and recommendations to improve processes / procedures. Evaluate and provide QA recommendations on all products, systems, and issues that are affected or may be affected by regulatory or...

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. Join our Quality Assurance (QA) Operations team at Sanofi’s Framingham Biologics facilities! We ensure cGMP compliance during manufacturing to guarantee the safety, quality, and efficacy of our products. As the QA Principal Compliance Specialist, you’ll provide quality support and direction to Manufacturing, Quality Control, and support functions. You will be...

Your skills could be critical in helping our teams accelerate progress. Our team is involved in developing regulatory product strategies for the Immunology and Inflammation therapeutic area, leading regulatory efforts in the development stage of drug products. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? The Regulatory Strategist provides regulatory expertise and guidance...

Your skills could be critical in helping our teams accelerate progress. Join our Immunology & Inflammation Regulatory Team as Global Regulatory Lead and you’ll be responsible for the development & execution of global regulatory strategies for your products in Sanofi’s diversified portfolio. Our team is involved in developing regulatory product strategies for the Immunology and Inflammation therapeutic area, leading regulatory efforts in the development stage of drug products. 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,...

Global Switch Regulatory Lead Location Morristown, NJ (Hybrid) About the job Are you ready to shape the future of Consumer Health? Your skills could be critical in helping our teams accelerate progress. Join our Global Regulatory team as Global Switch Regulatory Lead where you will be is responsible for developing and executing the regulatory strategy of the switch development program to approval of an assigned Rx-to-OTC Switch asset in target market. The regulatory lead reports to the Global Switch Science Lead. This role involves developing and executing regulatory program strategies for global programs, interacting with cross-functional teams, and collaborating with...

Your skills could be critical in helping our teams accelerate progress. Join our Regulatory Data, Digital and AI team as Head of Regulatory Affairs Master Data Management and you’ll drive transformative change by developing and executing master data strategies that ensure regulatory compliance and optimize data architecture and data interoperability across internal and external systems. The role encompasses oversight of interfaces, connectors, conceptual and logical data models, master data life-cycle management, and security within our Regulatory Affairs Technology Stack. A critical aspect of this role is fostering integration and collaboration across R&D Data Office, Digital, Research & Development (R&D), Manufacturing...

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. Your job, as Quality Assurance Shop Floor Lead within our Biosurgery Quality Team will be to e nsure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distributing of products through formal QA walkthroughs, Audits and Investigations that may result in additional training and recommendations to procedural...

The Principal RA Specialist –Business Partnerships will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors has revolutionized the way roughly 6 million people worldwide manage their diabetes. This is an exciting opportunity with responsibilitiesrelated to new strategic business initiatives globally , which include breakthrough advancement in diabetes management and digital health technology solutions to...

Validation Engineer – Casa Grande, AZ Nutrition Plant 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 the nutrients they need to live their healthiest lives. Casa Grande, AZ., is one of Abbott’s leading nutrition manufacturing plants in the U.S., reflecting our commitment to...

This position works out of our Plano Texas location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. We offer specialized devices for people suffering from chronic pain and movement disorders through solutions that deliver stimulation to the spinal cord, dorsal root ganglion and the brain. Our Proclaim series includes devices designed to deliver spinal cord stimulation (SCS) for the treatment of chronic pain, and dorsal root ganglion...

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

This Associate Director Regulatory Affairs will work on-site at our St. Paul, MN location in the Vascular Division. As a manager, the function of an Associate Director Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual will develop and supervise regulatory professionals. The individual has department level influence and is generally recognized as an expert resource both within Abbott and externally. The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive...

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

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...

Career Category Regulatory This position is primarily responsible to formulate and communicate the regulatory promotional position for approved and/or pipeline products. Responsibilities of the Promotions/Reviewer Manager is Attend required meetings in Amgen’s Material Approval & Compliance (MAC) process and review all preparatory materials Evaluate promotional enforcement activities and assess the changing regulatory environment to determine impact on Amgen Update the Promotions group on new learning’s and key takeaways from courses, congresses, and tradeshows Assesses promotional programs against Regulatory requirements Doctorate degree OR Master’s degree and 3 years of Pharmaceutical or Biotech experience OR...

This position provides leadership over Plasma Quality Release operations and Lookback to ensure plasma availability for further processing. The key area of responsibility is supervision of direct reports, including assignment of work activities and assurance of timely and compliant execution of tasks. Additionally, the position is responsible for establishing performance metrics and reporting metrics to management. Job Function and Description Lookback Process and/or verify Lookback/PDI Notifications/Observations received from plasma suppliers within the timeframe specified in department procedures and incompliance with regulatory requirements. Ensure Lookback/PDI Reference files are complete, accurate, maintained, and filed appropriately and meet all procedural requirements. Establish, prepare,...

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...

This position works out of our St. Paul, MN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Senior Supplier Development Quality Engineer , you'll have the chance to develop components and associated quality requirements for new product development initiatives. This position is responsible for managing supplier relationships, qualifying components and developing incoming controls that will drive the quality of future components. This will include technical support in the selection of suppliers...

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...

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...

Software Quality Assurance Engineer Our Princeton, NJ location has an opportunity for a Software Quality Assurance Engineer in the Instrument Operations Software technical group within Abbott Point of Care (APOC). In this role, the Software Quality Assurance Engineer will perform software and hardware testing, validation, and troubleshooting activities to ensure that software and processes are appropriately developed, implemented, and are in compliance with all applicable internal requirements and external regulations. What You’ll Work On Perform software testing activities for Manufacturing Software Engineering team. Develop software validation strategies. Write and execute software validation protocols. Assist in troubleshooting production floor issues,...

Quality Engineer I This position works out of our Plymouth location in the Electrophysiology Medical Device division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. We are seeking a passionate Quality Engineer to assure products, processes, and quality records conform to quality standards and establish compliance within Abbott's quality system. We need you to be responsible for maintaining a strong collaborative partnership with multi-functional teams. Help facilitate success by protecting patient safety and meeting business needs....

This position works out of our Westford, MA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. THIS IS AN ONSITE DAILY REQUIRED POSITION. NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION. OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL. MAIN PURPOSE OF ROLE Establish and maintain effective structures to ensure consistent implementation of quality systems at Abbott. Create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidances, and standards (LRGS). MAIN RESPONSIBILITIES Identify internal requirements and external laws, regulations, guidances...

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

The Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for class III and/or class IIb products. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. Duties and Responsibilities Collaborate with Operating Unit Regulatory Affairs Specialists and international regulatory colleagues to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to address questions from regulatory agencies. Provide support to currently marketed products as...

The Regulatory Intelligence & Research Director provides strategic global regulatory insights to the organization. This individual leads the identification, impact assessment, and communication of timely and relevant developments in the global, external regulatory environment that impact Vertex products. This individual partners with Regulatory Strategy Team Leads and other internal stakeholders to develop tailored and targeted communications of regulatory intelligence insights, including impact assessments to inform Vertex’s drug development strategies. In addition, the Regulatory Intelligence & Research Director is responsible for carrying out custom-made expert regulatory precedent research, in line with the needs of Regulatory teams, to inform highly effective regulatory...

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

Career Category Regulatory The Global CMC Regulatory Affairs Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Contributes to product teams...

Position Specialist, Quality Assurance 2nd Shift 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,...

The Compliance / Audit Program Manager will have responsibility for developing and executing global strategic internal audit and compliance improvement initiatives. This person should be a well-rounded individual who thrives in fast-paced, technically advanced, and collaborative settings. Responsibilities may include the following and other duties may be assigned. Plan, perform and implement process improvement initiatives (using Lean, DMAIC or Six Sigma processes to understand existing processes through to improvement). Organize, lead and facilitate cross-functional project teams. Develop metrics that provide data for process measurement, identifying indicators for future improvement opportunities. Collect data to identify root cause of problems. Take initiative...

Cardiac Ablation Solutions is focused on disrupting the Electrophysiology (EP) market to be the number one arrhythmia care, cardiac mapping, and ablation solutions provider for our customers and patients. Inspired by the Medtronic mission and dedicated to transforming the lives of people with cardiac arrhythmias, to date CAS has transformed the lives of over 1 million patients. This position is based in Mounds View, MN. The Associate Regulatory Affairs Specialist will work under the guidance of their manager and more senior regulatory specialists to provide support for Cardiac Ablation Solutions products. This role will include a blend of regulatory affairs...

We anticipate the application window for this opening will close on - 8 April 2025. Join our dynamic team at Medtronic's Fort Worth manufacturing site as a Quality Engineer I, where you'll play a crucial role in ensuring the highest standards of product quality and compliance. As a Quality Engineer, you will be at the forefront of driving continuous improvement initiatives, collaborating with cross-functional teams to enhance processes, and ensuring that our products meet rigorous industry standards. This position offers an exciting opportunity to grow your career in a fast-paced environment, contributing to Medtronic's mission of improving lives through innovative...

The Senior Director charged with overseeing all internal Quality Control Testing will lead a group of high-functioning QC analysts comprising approximately 50 individuals organized under 3-5 direct reports. The ideal candidate will be highly skilled in managing an integrated testing schedule that supports both a high-throughput late-phase, commercial manufacturing supply chain as well as a dynamic early phase clinical pipeline. The successful candidate will foster a collaborative environment and play a key role in executing the strategy that ensures a continuous global supply of Sarepta’s AAV gene therapies for neuromuscular disorders. The candidate will excel in a team-based environment, working...

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. Associate Director, Quality Assurance (QA) – Change and Deviation Program Owner,...

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. Associate Director/Director, Quality Assurance – Materials Management & Logistics 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. About the job At Lilly, we unite caring with discovery to...

The Associate Director, RA Global Regulatory Strategy, US & Canada 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. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements. This individual assures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs. This individual will support products...

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

As a Quality Product Lead US Fill/Finish , you will provide operational quality (OQ) oversight of combination product device assembly including pre-filled syringes/autoinjectors, and packaging, including but not limited to Product enabling e.g., technology transfer, PQ readiness, Quality Agreements, audit, PQ, registration Routine operations e.g., presence and Quality direction (e.g., real time problem solving, support, influence, decision making), deviation, investigation and incident management, review and approval of methods and protocols, periodic product reviews Audit/inspection e.g., inspection preparation / management / response, on-going inspection readiness, time cycle audit support This role will provide YOU the opportunity to lead key activities to...

General/ Vertex is in an exciting time of growth and innovation, and technology and data are valued as strategic assets. The Data & Software Engineering team in the Data, Technology and Engineering (DTE) organization is seeking an experienced technology leader to help create and maintain the strategy and roadmaps for data products, data assets and analytics and plan, manage and lead governance for data & software engineering projects in the clinical, quality and regulatory areas. As the Director of Engineering and Data Governance, you will report to the Sr. Director of DSE Governance and be responsible for managing the data...

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

About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit us at...

Legend Biotech is seeking Title as part of the Department team based in Location. Role Overview The Quality Systems IT Manager is responsible for the system and platform-level management and support of critical GxP computerized systems. This role will take ownership of the development, enhancement, and support of validated computerized systems which support GxP activities and is a critical role in the company with significant impact on strategic projects and regulatory compliance. Key Responsibilities IT Platform/System leadership and administration for Veeva vaults (Quality, RIM, Clinical). Oversee change management activities in support of operations, expansion and optimization of use, business...

In this exciting role as an Associate Quality Application Specialist, you will support Synergy Business as a member of the Internal Supplier Quality Organization for the West Platform. The role is both dynamic and demanding. Internal Supplier Quality plays a vital service-oriented role that impacts and collaborates with various departments across the site, including Finance, Manufacturing, Compliance, and Supply Chain. Quality operations support these areas in multiple ways. Responsibilities may include the following and other duties may be assigned. Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate...

As a member of Supplier Quality Engineering at Medtronic Energy and Component Center (MECC), you will be responsible for management of external suppliers to MECC. You will lead oversight of supplied products, ensuring conformance to purchased material requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations. 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...

Job Title Director Quality Assurance The Director of Quality Assurance leads management team and technical staff of multiple groups/functions within business unit/product specific division Quality organization responsible for ensuring product safety, reliability, and quality. In this role, the Director will ensure that processes and staffing are appropriately developed and implemented to maintain the quality system, set strategic vision/goals in alignment with site organization and division, ensure compliance within organization to all applicable internal requirements and external regulations, establishes quality systems and plans to assure manufacture of the highest quality products to exceed customer requirements. May interfaces with outside...

This position works out of our Menlo Park, 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. Roles and Responsibilities The main responsibility of this role is to support production and sustaining quality engineering tasks. Some examples are listed below Manage unplanned events, release of unplanned event areas, and product accept/reject decisions. Support production lines per line support schedules (including accept/reject decisions). For potential nonconformities, determine product impact and manage product containment. Draft,...

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 II , you’ll have the chance to assure products, processes, and quality records conform to quality standards and establish compliance within Abbott's quality system. We need you to be responsible for maintaining a strong collaborative partnership with multi-functional teams. Help facilitate success by protecting patient safety and meeting business needs. You will...

Would you like to apply your Regulatory Affairs expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we do this with integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe. Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs...

Are you energized by a highly impactful quality role that drives process improvement and broad stakeholder engagement? If so, this Senior Manager, Third-Party Quality opening could be an ideal opportunity to explore. As a Senior Manager, Third-Party Quality, you will be responsible for designing, developing and implementing Third-Party Quality strategies and quality oversight for external GMP services provided to GSK R&D to ensure that GSK external providers of critical services (CMOs) comply with GSK data integrity and quality standards, GxP regulations and meet national health authority requirements. Promote and implement a Quality and Safety culture within GSK R&D. Provide GSK...

About the role Join Takeda as the Head of Ethics & Compliance Operations, Oncology at the director level, where you will be a key forward-thinking leader, helping drive ethical behaviors, risk identification and mitigation, and compliance with global requirements. You will respond rapidly to changing environment and business needs; as E&C, you will be close to the market and encourage ethical behavior in line with Takeda’s values. In doing so, you will respond rapidly to changing environment and business needs. By working in an agile manner, you will ensure balance between stable structures, governance, processes and systems, and dynamic approaches...

That’s what makes us Roche. PAC-QC is one of the four departments that comprises Analytical Development and Quality Control (ADQC) organization within Pharma Technical Development, US (PTDU). As a GMP department, PAC-QC is responsible for implementation of control system for IMP biologics, managing the characterization and extension of expiry of Reference Standards, authoring/reviewing the QC related sections of INDs/CTAs and BLA filings, release and stability testing of IMP products, and QC operations supporting the GMP functions in ADQC and partially gRED. The Opportunity This role will support multi-disciplinary teams within PAC-QC utilizing expertise of various Roche Quality Systems that create,...

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

To provide expert technical and analytical support to the Quality Control function including instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation and exploitation of new technology. The individual should be qualified to graduate level/or equivalent in a scientific field, with experience of working in a Good Manufacturing Practice laboratory environment. The selected candidate will have strong knowledge and understanding of analytical chemistry and laboratory instrumentation, as well as Good Manufacturing Practice/Global Laboratory Practice. Must have an understanding of the Quality Control function, and it’s role and importance to the business. Typical Accountabilities · Conduct activities and interactions consistent...

The Associate Director, R&CD QA Pharmacovigilance, with minimal supervision, will support the management of GVP quality oversight, GVP-related audit program and for providing regulatory/GVP guidance. This position will liaise with internal groups such as Pharmacovigilance Operations, Safety Evaluation & Risk Management, and Market Research, as well as external groups including contract auditors in an effort to ensure a high level of quality and consistency across the Sarepta platform; design and oversee the audit strategy; assist the GVP team in identifying and implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable...

We are looking for a Senior Quality Engineer (Software Design Controls) who will beinvolved in quality management system (QMS) and software development life cycle(SDLC) activities, in accordance with FDA’s Quality System Regulation (QSR), ISO 13485, and other applicable regulatory requirements, as well as best practices in the software industry. This position is within the Tempus Quality Assurance (QA) group. Responsibilities ● Support Tempus’ SDLC activities for medical device software and Software as a MedicalDevice (SaMD). ● Support Tempus’ QMS activities by maintaining relevant procedures, identifying improvement opportunities, and providing training ● Ensure required documentation and DHF deliverables are generated...

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

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021. We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in...

The Product Quality Director is accountable for end-to-end quality oversight of small molecule, biologics, or device program(s) throughout clinical development, commercialization, filing, approval, launch, and post approval lifecycle management activities. This oversight includes setting and maintaining overall Quality strategies in support of commercialization efforts including establishing relevant product quality standards for current or novel technologies (including devices where applicable), ensuring QA and cross-functional alignment with industry and regulatory expectations, identifying product quality risks and mitigations throughout the development lifecycle of the assigned program, through commercialization and decommissioning. The candidate should have a good understanding of drug development and commercialization and...

GxP Quality Operating Model (QOM) Process Lead What you will do GxP Quality Operating Model (QOM) Process Lead, you will support the development, implementation, and sustainability of the GxP Quality Operating Model (QOM) with a focus on governance, process architecture, and cross-functional collaborator management. This position will be classified as a remote position and will report to the Senior Director, GxP Quality. This role will require a deep understanding of R&D and Operations strategy to design and optimize the GxP Process Architecture within the GxP Quality Operating Model. By integrating end-to-end processes under global process owners, this role will...

As a Quality Inspector II/III at our Billerica site, you will be essential in making sure our cutting edge cardiac ablation devices meet the highest quality and safety standards. You will meticulously examine components and assemblies, ensuring they meet precise specifications and function correctly. Leveraging your expertise and the appropriate tools, you will assess whether products conform to our stringent quality criteria or require modifications. By adhering to established protocols and instructions, you'll contribute to operational efficiency and guarantee the safety and reliability of our products for patients. Your sharp attention to detail and unwavering dedication to quality will reinforce...

The Program Compliance Senior Analyst (PCSA) is responsible for monitoring and reconciliation to ensure data is accurate and compliant with 60+ individual country policies; and company OPPFs, procedures, and CFMs for all activity including top tier Congress activity. The PCSA is also responsible for the successful close-out of activities, ensuring financial, transparency and compliance accuracy of all costs and activity associated with events planned within company Business Service Group or by Third Party Vendors, as required by country specific, federal and state government reporting and regulations. The PCSA role includes the continued enhancement of Cross Border Transparency requirements by executing,...

Purpose This role is primarily responsible for supporting AbbVie’s pipeline, by supporting batch disposition activities and ensuring high-quality clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. This is achieved by effectively partnering with the business, ensuring risks are mitigated appropriately and supporting efficient review of clinical supply batches to support continued uninterrupted access to clinical supplies. The successful candidate will be able to manage multiple tasks and adjust priorities based on supply needs. This position requires the ability to positively interact with multiple functional areas quickly and effectively resolve batch record documentation related...

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

Senior Director, Drug Substance Validation and Tech Transfer Location Gaithersburg Shape the Future of Biologics at AstraZeneca Are you ready to lead with purpose and drive innovation that transforms lives? Join AstraZeneca as our Senior Director, Drug Substance Tech Transfer and Validation and take on a pivotal leadership role in delivering life-changing medicines to patients worldwide. As part of our Global Technical Operations team, this role places you at the forefront of scientific and operational excellence. You’ll lead groundbreaking initiatives across our biologics pipeline, ensuring seamless drug substance transfers and validations that support the delivery of transformative therapies. Why AstraZeneca?...

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

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. What You Will Achieve In this role, you will Perform on-the-floor QA tasks within the manufacturing areas as needed, collaborating with manufacturing and other departments to provide routine quality support, and maintain inspection readiness. Conduct on-the-floor QA review of executed batch records and other manufacturing...

Team is working hybrid and position will be onsite 2 days/week in Carlsbad, CA. At our Quality Engineering department in Medtronic, plc, we focus on providing Engineering support for Design and Development, Quality Compliance, and Risk Management activities across the Ventilation Service Solutions portfolio. As a Quality Engineer II, you will work within a team of four engineers to apply Design Controls and Risk Management principles to ensure that any changes to our sustaining ventilation products are safe, effective, and compliant to associated Regulations and Methods. Responsibilities may include the following and other duties may be assigned Responsible for...

This opportunity is an exciting and challenging role that will be key to Gilead's success as we work towards bringing new combination products, such as vial kits and pre-filled syringes, to market. You will be a key Quality person supporting these new product lines in the commercial stage, starting with collaborating with the design and development team and the Gilead network on Quality Assurance related activities. We are looking for a Quality professional to ensure that we have end-to-end Quality support of our combination products. Roles/Responsibilities Provide Quality oversight for QMS development and maintenance. Create/revise/execute SOPs and other controlled documents...

Responsibilities Serve as a quality engineer for medical device combination product development projects, with a strong emphasis on design control and risk management activities. Collaborate with device engineering on new combination product development, supporting design verification, validation, and transfer activities. Contribute to quality improvement initiatives and ensure compliance with relevant regulations and standards, including FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and Gilead’s quality system requirements. Plan and implement approved quality improvement action items and deliverables. Interface with internal stakeholders, contract manufacturers, and suppliers to resolve complex technical issues related to drug-device combination products,...

In Pharma Technical Regulatory (PTR) we develop and maintain our licenses globally and influence Health Authorities in their thought processes to develop regulations. In the role of Head of Pharma Technical Regulatory , you will be a member of the Global Pharma Technical Operations (PT) Leadership team and report directly to the Head of Global Pharma Technical Operations. You will lead a global, multilayered organization of about 350 FTEs with approximately 8 direct reports, with a budget responsibility of approximately 100m CHF. As a member of the PT leadership team, you will work collaboratively as part of a team to...

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

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. Compan Overview At Lilly, we serve an extraordinary purpose. We make...

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

About the role This position is responsible to ensure that products meet the highest standards of quality and consistency throughout the production process. Quality Control Lead is also responsible for leading a team of analysts, ensuring compliance with local, global, and regulatory standards are maintained. This position will support and drive improvements in safety, customer satisfaction, employee development, and continuous improvement, consistent with plant objectives. Additionally, the Lead Analyst is responsible for leading a team of QC professionals, conducting root cause analysis for defects, collaborating with cross-functional teams, and driving continuous improvement efforts to optimize quality and efficiency within the...

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

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

About the Role As the QC Analyst, you will conduct biological or chemical and physical analyses on raw materials, in-process samples, product samples and other samples collected from manufacturing areas. This position is on site and you will report to the AQC Manager. How You Will Contribute Use laboratory instrumentation including analytical equipment, autoclaves, and incubators. Perform test equipment, equipment maintenance and calibrations. Perform assays requiring precise analytical skills and understanding of biology and chemistry principles. Conduct biological, chemical, and physical analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring. Maintain data integrity and...

Are you passionate about serving patients with quality products? Within our Research and Development Division, the Global Clinical Supply (GCS) organization is accountable for the end-to-end supply chain (planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites and patients) across the product portfolio to enable the execution of Phase I-IV clinical trials in 60+ countries in accordance with worldwide GxP regulations as set by the US cFR, EU eudralex, and all applicable jurisdictions as well as Sarbanes-Oxley (SOX) financial, and Environmental Health & Safety agency guidelines. GCS operates in close collaboration with Discovery Sciences Clinical Supply (DSCS),...

Job Title Validation Engineer Process Engineer - Des Plaines, IL The Validation Engineer will be primarily involved in preparing, drafting and execution of validation protocols. They ensure the assigned area of Validation are effectively managed and all elements follow the requirements specified by Abbott Molecular Diagnostics Division Quality System and in the relevant international standards. This individual will also participate in the development and improvement of engineering solutions for equipment, processes, parts and components. What You’ll Work On Equipment Validation Validate automated manufacturing equipment, ancillary equipment, facilities, and utilities. Draft Validation Change Requests and align on validation requirements with...

Quality Assurance Senior Manager, Drug Substance What you will do As a Quality Assurance Senior Manager, you will lead our Cell Bank QA and our B7 QA teams and will serve as the Quality Leader for Good Manufacturing Practices (GMP) Operations within the Cell Bank and the B7 commercial drug substance manufacturing facility. The QA Senior Manager will lead a team of QA staff, collaborate with cross-functional partners, and provide QA leadership and oversight in support of the operational team’s key responsibilities which include Meet site demands for cell bank production for clinical and commercial programs in the cGMP...

Compliance Sr. Director U.S. Rare Disease What you will do In this vital role The WC&BE Sr. Director, Rare Disease, will be responsible for upholding the reputation of Amgen and driving ethical solutions for the patients we serve. Reporting to the Associate Vice President of Compliance, this position will serve as the primary compliance business partner for the Amgen Rare Disease Business Unit, leading a team that works closely with that organization's leadership to maintain a strong culture of compliance, integrity, and ethics. This position would ideally sit in proximity to either our Thousand Oaks, CA or Deerfield, IL...

About the role The EHS Representative – Environmental Compliance and Sustainability (ES) will partner with Los Angeles (LA) and Van Nuys (VN) site personnel to promote a EHS culture, complete company safety and health policies, and ensure compliance to all applicable local and regional regulations. You will support the following environmental compliance programs such as storm water, wastewater, hazardous waste, medical waste, and air pollution; and, sustainability programs such as waste reduction, landfill diversion, reducing carbon emissions, and reducing water use. You will partner with subject matter experts from multiple departments to support the facility's ongoing compliance and risk reduction...

Reporting to the Director, Research & Clinical Development Quality Assurance, the Senior Manager, Research & Clinical Development QA, Audit Management will be responsible for monitoring and evaluating the compliance of clinical studies and Sarepta’s oversight of studies to FDA and International regulations and guidelines, as well as corporate policies and standard operating procedures. The Senior Manager will participate in vendor risk assessment and vendor qualification, GxP audit consultation management, and the development of performance, quality and risk metrics. Investigator site and internal process audit coordination and execution are additional aspects of this role. This position will also participate in inspection...

As VP of Regulatory Affairs for Oncology and INT, you will lead and develop the regulatory strategy for Moderna’s oncology and individualized neoantigen therapies programs. You will work collaboratively to articulate clear and compelling regulatory strategies, highlighting risks and opportunities, and leveraging the mRNA platform technology. Your leadership will be pivotal in navigating the complex interplay between the FDA, EMA, and other international health agencies, ensuring successful registration and commercialization of oncology and INT products. Here’s What You’ll Do Strategic Leadership Design and execute the strategic vision for regulatory affairs in Oncology and INT, ensuring alignment with Moderna’s global business...

Moderna is seeking a Sr. Manager of Regulatory Strategy to provide regulatory support for our Flu and Covid Combination programs. Based in one of Moderna’s East Coast hubs (Cambridge MA, Bethesda MD, or Princeton NJ), this role includes but is not limited to managing INDs, marketing applications, and other regulatory submissions (orphan drug designations, pediatric plans, DSURs, MAA/BLA/NDA, etc.). Here’s What You’ll Do Works with global regulatory lead(s), regulatory strategists, Global Regulatory Sub-Teams and project teams regarding the development and execution of regulatory strategy through the product development lifecycle. Coordinate, develop and contribute to content and format of regulatory submissions...

As an Associate Director of Regulatory Projects, you will be a forward-thinking leader, driving both the strategic and operational aspects of global regulatory projects. Acting as a key strategic partner, you will develop proactive regulatory plans, identify innovative pathways to success, and make decisive, progressive decisions that align with broader organizational goals. In this role, you will be hands-on in managing day-to-day project execution, while maintaining a clear focus on the bigger picture to ensure regulatory milestones are achieved. Here’s What You’ll Do Serve as a strategic partner by leading the development of forward-looking global regulatory plans for ongoing late-stage...

We are seeking an experienced and dynamic Regulatory CMC Project Senior Manager to join our team. In this role, you will manage regulatory submissions related to Chemistry, Manufacturing, and Controls (CMC) for the development and commercialization of biopharmaceuticals, biologics, or small molecules. You will lead cross-functional teams to ensure timely, high-quality regulatory submissions and approvals, and manage project timelines and submission-related processes. The ideal candidate will have a strong background in CMC regulatory submissions, project management, and a deep understanding of global regulatory submission frameworks (FDA, EMA, ICH, etc.). You will be instrumental in supporting the launch of innovative therapies...

The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning, creation, and submission of regulatory submissions. In collaboration with the Regulatory Lead, you will manage and prepare high-quality global submissions, both in-house and via CROs, ensuring timely delivery of compliant submissions to global health authorities. The Global Publishing Manager provides regulatory operations expertise to cross-functional submission project teams, promoting and ensuring excellence in the planning, preparation, and delivery of regulatory submissions. You will act as the primary point of contact for daily submissions for major submissions and lead a team of publishing specialists. At Moderna, we act with...

The Senior Manager, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials across various communication channels. This role will serve as a key liaison between Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic regulatory guidance on advertising and promotional activities. The ideal candidate will have expertise in FDA regulations, OPDP (Office of Prescription Drug Promotion)/Advertising and Promotional Labeling Branch (APLB) guidance, and industry best practices. Here’s What You’ll Do Review and approve promotional materials, corporate communications, and disease awareness campaigns to ensure compliance with FDA and other applicable...

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

The Associate Director – GMP Operations (Compliance) is accountable for quality oversight of QMS system records (deviations, CAPA, and change controls) supporting cell and gene therapy programs throughout clinical and commercial development to commercialization. The Associate Director is an advanced technical resource in the principles and application of quality assurance and compliance, has experience in participating in cross-functional teams working with deviations, Root cause analysis and CAPAs, as well as developing and communicating department QMS metrics and lead ing internal Tier meetings such as investigation and change control review boards. This position reports to the Director, GMP Manufacturing Technical Services...

About This Role As an Associate Director IT, Veeva Quality Docs & Training, your leadership will be instrumental in spearheading the deployment and management of vital applications, Veeva Quality Docs and Veeva Vault Training. In this role, you'll ensure top-notch service delivery across the entire lifecycle—from project inception to enhancements and support. By collaborating with cross-functional teams, including business analysts, technical architects, and project managers, you'll drive improvement to these new modules that align with our strategic IT goals. You will be the linchpin that brings together business needs with technological solutions, thereby enhancing our operational excellence and contributing significantly...

About This Role As an Associate Director IT, Veeva Quality Docs & Training, your leadership will be instrumental in spearheading the deployment and management of vital applications, Veeva Quality Docs and Veeva Vault Training. In this role, you'll ensure top-notch service delivery across the entire lifecycle—from project inception to enhancements and support. By collaborating with cross-functional teams, including business analysts, technical architects, and project managers, you'll drive improvement to these new modules that align with our strategic IT goals. You will be the linchpin that brings together business needs with technological solutions, thereby enhancing our operational excellence and contributing significantly...

The Associate Director, Regulatory Labeling, will be responsible for initiating, leading, reviewing, and approving labeling strategies to ensure compliance with product registrations and regulatory requirements worldwide throughout the product lifecycle. Additional responsibilities will include monitoring regulatory compliance trends in industry and interpreting new regulations, guidance documents, and enforcement letters. The Associate Director will train teams on regulatory issues pertaining to product labeling and will work cross-functionally in the development and implementation of labeling for Apellis’ product portfolio that supports the achievement of business objectives. Key Responsibilities Include Lead the development, review, approval, and implementation process for target product profiles...

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

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

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

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

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

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...

Associate Regulatory Affairs Director Introduction to role The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARAD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARAD provides regulatory expertise and guidance on procedural and documentation requirements to all collaborators and cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives globally. Accountabilities Lead and/or contribute to the planning, preparation, and...

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 (three positions available) . 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 engineering principles, problem-solving skills, and a commitment to continuous improvement. This role will support the Advanced Surgical Instruments operating unit supporting products including (but not limited to) Surgical Stapling, Robotic Surgi cal Devices, and Powered Instrumentation. Key Responsibilities Support...

The Senior Manager, Quality Control is responsible for Quality oversight of analytical methods and specifications used to test and release Acadia’s products. This position assists in the establishment of commercial analytical methods used to support manufacturing, release, and stability testing that are conducted at Acadia drug substance (DS) and drug product (DP) Contract Service Providers (CSPs). Responsible for the Quality oversight of CSPs performing GMP analytical testing and review of analytical method validations/transfers between laboratories. This position will be responsible for the quality review of release testing and stability data of DS and DP. Coordinate efforts with CSPs to report...

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

Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise to be based in one of Moderna’s US offices. This is a role intended for a forward looking, creative and agile regulatory strategist able to anticipate and address the challenges involved in developing and registering oncology therapeutics/vaccines based on messenger RNA technology, an unprecedented new drug modality in the US and other global markets. The Associate Director will be a strategic leader within the Global Regulatory Strategy, Oncology group. They will be responsible for developing and executing regulatory plans for the US market...

As part of GSK’s ambition to “Supercharge our data capability”, the Onyx Research Data Platform organization represents a major investment by GSK R&D and Digital & Tech, designed to deliver a step-change in our ability to leverage data, knowledge, and prediction to find new medicines. We are a full-stack shop consisting of product and portfolio leadership, data engineering, infrastructure and DevOps, data / metadata / knowledge platforms, and AI/ML and analysis platforms, all geared toward Building a next-generation, metadata- and automation-driven data experience for GSK’s scientists, engineers, and decision-makers, increasing productivity and reducing time spent on “data mechanics” Providing best-in-class...

This position works out of our Abbott Park, IL location for our AQR Abbott Quality and Regulatory division. The function of the Quality Program Manager is to provide leadership, oversight, and project management covering Abbott’s Quality System. This includes division / business support and quality expertise and consulting activities. The Quality Program Manager will support Divisions across all Abbott Quality Systems in activities associated with quality, regulatory compliance areas. The candidate will provide strategic, technical, and business support across all Quality Systems by interacting directly with Divisions and providing quality and technical expertise and strategic consulting activities for the Divisions....

Validation Engineer (CSV) Location Warren, NJ The Validation Engineer CSV supports the successful implementation, deployment, maintenance, and administration of all validated computerized systems in compliance with policies, guidelines, and procedures. Through this work, the validation engineer supports the successful operation of facility, laboratory and business functions at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, identifies issues or unmet needs and initiates efforts to address them. This individual works independently to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent is able to recognize problems of...

POSITION SUMMARY The Director, Regulatory Affairs, will be responsible for leading regulatory activities for one or more products through all stages of a product’s lifecycle. The Director may manage a group of individuals responsible for developing global regulatory strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities. The Director will be expected to provide guidance to the product teams supporting products in their portfolio. In addition, the individual will be responsible for preparation, review, and approval of related agency correspondence and regulatory applications. The candidate will need to successfully manage multiple projects in a...

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Analytical Lifecycle Management The Director Analytical Lifecycle Management is vital for the success of Clinical Biologics QC, providing strategic leadership and overseeing daily operations. Responsibilities include managing Clinical specification strategies, reference standards and critical reagents...

Material Compliance Associate What you will do In this vital role you will be responsible for assisting the Brand Marketers build and monitor their projects through the Material Approval and Compliance (MAC) review process. The MCA will quality check files submitted for review, collect “live” edits during compliance review and approval meetings, and edit submission documents within the electronic review system, Veeva. They will ensure all materials submitted adhere to Amgen MAC Standards and FDA requirements throughout the process. Responsibilities Supports one Material Approval and Compliance (MAC) Team. Supports Global Initiative/Other Project. Quality check submissions for review to ensure...

Senior Material Compliance Associate What you will do In this vital role you will be responsible for leading MCA Staff members and assisting the Brand Marketers build and monitor their projects through the Material Approval and Compliance (MAC) review process. Responsibilities Lead 1 MAC Team Provide process guidance/ system pathways and issue resolution when issues arise to the MAC Team and Cross Functional Partners Manage MAC, Office Hours, and Prioritization Partner with Commercial Director and Brand teams Manage elevation process Ensure compliance along all phases of the MAC process Serve as a neutral partner to ensure business needs are...

The Associate Director, Therapeutic Area Audit Strategy Lead will be mainly responsible for developing the TA audit strategy and overseeing the planning, conduct and reporting of internal and external audits of clinical trial investigator sites. Key Responsibilities Design , develop and implement the Clinical Audit Strategy for various Therapy Areas (ICN & HOCT) . Oversee the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and process/systems, including for- cause and directed activities. Provide input in the global audit plans based on identified signals/trends/risks/gaps . Partner with R isk, G overnance, O perations (RGO)...

This position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. The Manager of Quality Assurance will be responsible for establishing and maintaining quality standards, ensuring compliance at every stage of the process. What You’ll Work On Develop and implements quality assurance strategies and regulations. Assesses potential risks, ensures compliance and gives recommendations. Takes responsibility for all quality control aspects of...

That’s what makes us Roche. Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. The Opportunity The Regulatory Program Director is develops and implements regulatory strategies for combination products and standalone physical devices in accordance with domestic and international regulations and guidance. In addition to portfolio-related responsibilities, the individual plays a role to build...

About the role The Quality Control Scheduler will be responsible for maintaining and supporting 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. 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 need. How you will contribute Independently maintain schedules for Quality Control using system tools (i.e Smart QC). Coordinate scheduling activities with support groups, includes...

About the Role As the Quality Control Analyst II - Bio Chemistry, you will focus on the daily lab operations and execution of testing to support manufacturing operations. Testing may include samples from drug substance and drug product, manufacturing, stability, raw materials and various protocol studies using test methods. The assays range from pH, enzyme concentration to more complex assays such as SDS silver Gels, PCR, and enzyme activity. You will maintain operational and GMP readiness of the QC areas and participate in more complex projects, operational excellence projects and quality systems. You will report to the Quality Control Supervisor....

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 Senior Director of Global Regulatory Affairs – CMC (GRA-CMC)...

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 Technician, Incoming Quality Assurance will support activities within Warehouse...

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 The CPQA-ARC Quality Assurance (QA) Associate Complaint Investigator (hereafter referred...

Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role Overview The Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will serve as the business process owner for the Corrective and Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes. Key Responsibilities Provide oversight to the CAPA program for the CAR-T manufacturing site. Oversee metrics, trending,...

Coordinates schedules and implementing activities for the Distribution function, that include overseeing personnel, directing operations and following-up on transactions, to ensure department standards and the Regulations are observed. Manages sterilization, returned goods, receipt, storage and transaction of finished goods in accordance with validated procedures. Ensures that customer orders are processed quickly and accurately to meet Division standards. WHAT YOU’LL DO As a Validation Engineer, you’ll have the chance to create and implement the Abbott Division validation program. Creates and maintains validation documentation for new and existing systems and processes subject to design control. Ensures that validation activities are implemented for...

The Sr. Validation Engineer plays a pivotal role for the Columbus manufacturing site. The role ensures the validation change management process follows the established policies and procedures with an emphasis on timely approvals and consistent approaches. The main functions are periodic review of existing validation packages, monitoring of active validation packages, setting expectations for validation packages, and ensuring compliant reviews are executed. WHAT YOU’LL DO Responsible for implementing and maintaining the effectiveness of the quality system. Assures that the plant validation program is executed consistently with the Abbott Validation Policies. The Validation Engineer will be part of the Engineering Team...

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...

About the role The Quality Operations Supervisor oversees the daily activities related to the Quality Assurance Operations team. You will work as part of teams providing quality leadership and focus on product quality and compliance through Quality on the shop floor (QOTSF), Acceptable Quality Limit (AQL) inspection, Incoming raw materials release, Documentation review (Batch records, electronic batch records), Investigation approvals and Quality oversight of manufacturing processes. You will report to the Associate Director of Quality Assurance Operations. How you will contribute Supervise a team of Quality Technicians and Quality Analysts. Responsible for the team's continuous development and ensuring they are...

About the role As the Site Quality Head you will lead the Takeda Brooklyn Park Quality organization. Design and implement the Quality organizational structure. Design & direct Quality’s talent development program in alignment with HR and site programs. Build and maintain a best in class Quality team focused on biologics manufacturing and testing excellence. Create the Quality vision for Brooklyn Park to drive implementation of processes and systems that ensure continuous global GXP compliance. Set the Quality culture of Brooklyn Park through focus on people, science, and systems. Own and drive budget and resource planning, tracking and accountability for the...

Job Title Supplier 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 Supplier Quality Engineer is within our Infectious Disease Developed Markets business unit located at all sites under Abbott Diagnostics Scarborough . This role will perform daily activities required to ensure that all purchased or otherwise received materials, products and services that can impact the quality of product or service provided conform to predefined...

The Quality Assurance Operations co-op provides students with an overview of Gene Therapy Manufacturing - Quality Assurance responsibilities including general knowledge of Quality Review Process of GMP Production Batch Records and Change Controls. The co-op will receive hands-on experience in developing the skills to lead and drive Continuous Improvement initiatives aimed at Error Reduction and Quality Review optimization. In addition, the co-op will have a unique networking opportunity to manage their own project by working in cross-functional teams to support the timely release of high-quality products to serve patients globally. The Opportunity to Make a Difference This application is for...

The Global Regulatory Affairs Chemistry, Manufacturing and Control (GRA-CMC) co-opportunity provides students with an overview of Regulatory Affairs (RA) responsibilities including general knowledge of global health authority requirements and guidance to develop regulatory CMC strategies to enable the development and/or lifecycle management of pharmaceutical products. The co-op will receive hands-on experience in developing the skills to prepare various global regulatory CMC submission documents for products in drug development and lifecycle (commercial) space, all while being an active contributor to the GRA-CMC Team. In addition, the co-op will have a unique networking opportunity to manage their own project by working in...

Purpose To provide strategy for Quality staff by managing daily activities with consideration to the LRP. Strong decision making and communication for issue resolution within the Quality System. Responsibilities Responsible for ongoing compliance with and understanding of applicable policies and procedures, including cGMP Defines strategy for staff to manage daily activities for planning and implementing the LRP. Manages direct reports including hiring, setting performance expectations, reviewing performance and developing staff to support the Quality needs of the plant. Quality oversight of drug product manufacturing and finished good packaging, as well as batch record review and batch release. Supports internal and...

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

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 Senior 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...

In this exciting role as a Senior Quality Engineer , 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 initiatives. This is an onsite role at the Danvers, MA location. Responsibilities Include Provide Quality Engineering support for commercial medical device products. Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise...

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...

The Senior Director, Regulatory Strategy, is a regulatory leader with expert technical and tactical experience in global regulatory strategy and will be responsible for overseeing the development and implementation of advanced global regulatory strategies for a multi indication phase 3 development programs to support potential regulatory Submissions in 2026 and beyond. This incumbent will play a major role in shaping cohesive regulatory strategy across the assigned programs and ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy. This roles responsibilities may be global, regional or local depending on the position and assigned region. This role will understand and translate...

– 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 - · Responsible for following SOPs for managing regulatory documents and records in Global Product Registration (GPR) system and overall regulatory operation activities. · Ensure communications convey all necessary detail and adhere to applicable regulatory standards. · Have a basic understanding of Structural Heart product families. Organize product information for internal procedures, quality plans and audit needs. · Understand Windchill and other...

This S enior Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This Senior Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment. You will be responsible for managing a team overseeing the Diabetes Care product...

This position works out of our Abbott Park, IL location for our GENC General Counsel division. The Privacy and Regulatory Paralegal supports the Privacy and Regulatory attorneys by staying informed about global developments in privacy, cybersecurity, AI, data, and FDA regulations (covering medical devices, diagnostics, food, and drugs). This includes monitoring new regulations, published guidance, and enforcement actions. Works under the supervision and direction of attorneys. What You’ll Work On Legal Assistance Assist attorneys to resolve routine and moderately complex to complex legal matters that involve various functional areas or divisions within Abbott with minimal supervision. Legal Research and...

We are seeking a motivated and detail-oriented Quality Assurance (QA) Co-Op to join our dynamic team in the Quality Management department. This internship provides an excellent opportunity to gain experience in the biotechnology industry and clinical research via a Quality lens. The Co-Op will gain hands-on experience in clinical quality assurance practices, learn about quality management systems that support clinical trials, and assist with managing Health Authority (e.g., FDA) inspections which lead to drug approvals, and help maintain a culture of quality excellence. The Opportunity to Make a Difference This application is for a 6-month co-op program that will start...

The Senior Manager 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. Responsibilities Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new...

The Senior Manager 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. Responsibilities Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new...

Use Your Power for Purpose Candidate will be responsible to provide leadership for will be responsible for managing a team of Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity within the Rochester Quality organization. Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and performs second level reviews as required. Provides oversight of department, ensuring proper use of assets, budget, and...

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North, South and Central America, Europe, Africa, Asia and Australia. Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic status. POSITION OVERVIEW As a Director, Early Oncology Global Regulatory Affairs, you will develop and execute Oncology regulatory strategies in alignment...

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue elite medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Sr. Specialist Device Quality, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. We offer one of the most exciting, fast paced,...

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue elite medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Sr. Specialist Device Quality, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. We offer one of the most exciting, fast paced,...

Primarily responsible for quality systems implementation and support. This role manages activities supporting the QA System and business driven objectives. The Manager, Quality Systems Support has leadership responsibilities over all laboratory enterprise systems providing oversight to business system owners and the site digital system leads/administrators. In addition to these responsibilities the Manager, Quality Systems Support owns the business change management processes and data governance models within the enterprise systems ensuring compliance in all sites within the AbbVie enterprise. Manage team of 2 direct reports; QA System Specialists. Oversee projects for implanting new IT Systems, setting robust implementation strategies and tactical...

Join our team of experts as a Sr. Specialist, Regulatory Strategy! Take the lead in preparing document packages for regulatory submissions, ensuring compliance with local and regional registration requirements and company policies. Stay ahead of regulatory changes, maintain tracking systems, and recommend strategies for swift clinical trial approvals. Be the go-to contact for internal projects and program activities. Shape the future of regulatory strategy with us. _ Your Contributions (include, but are not limited to) As a Regulatory Affairs Specialist where you will play a pivotal role in preparing and submitting critical documents to regulatory authorities with precision and finesse...

OBJECTIVES/PURPOSE The Quality Operations Manager is responsible for the quality oversight of laboratory testing operations in two lab locations in accordance with established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on Good Manufacturing Practices (GMPs), the Clinical Laboratory Improvement Act of 1988 (CLIA), and applicable Takeda and BioLife policies, and quality initiatives. Manages through subordinates the coordination of the activities of the Quality Operations Organization of two lab locations. Is responsible for results in terms of testing quality and conformance to regulations and Takeda quality policies. ACCOUNTABILITIES Establishes and oversees quality operations...

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...

The Chemistry Manufacturing Controls Senior Manager will participate in the execution of multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and submission of regulatory CMC documentation. This role also acts as a resource for regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs. Key Duties and Responsibilities Prepares and reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies Develops global regulatory CMC strategies for investigational and/or commercial products...

This position is based in our Plymouth, MN location in the Office of Ethics and Compliance. As the Senior Business Systems Analyst supporting the Medical Devices Division, you will provide compliance guidance and data-driven analysis to key business stakeholders, and leverage data insights to inform elements of Abbott’s compliance program at the business unit and division-wide level. You will also support efforts to streamline compliance trending, risk identification, risk mitigation, and remediation across Abbott’s Medical Devices Division. Join Our Team as a Senior Business Systems Analyst! We are seeking a dynamic professional with a proven track record in developing data-intensive...

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...

Summary Lead and manage Computer System Validation (CSV)/Computer System Assurance (CSA) and qualification efforts for systems used across multiple functional business organizations supporting regulated processes. Engage with project team for CSV projects ensuring efficiency, consistency, quality of work and compliance with external regulations and internal procedures. Collaborate with IT Delivery teams, business users and internal business functions staff to ensure that CSV activities are planned and executed in accordance with internal procedures. Work with one-up manager and peers to propose effective and efficient quality strategies for IT implementation across multiple business functions. Refine and standardize SDLC and CSV processes for...

This position works out of our Westford, MA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. What You’ll Work On This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. MAIN RESPONSIBILITIES This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. MAIN RESPONSIBILITIES Identify and implement effective process control systems to support the development, qualification, and on-going...

This Regulatory Affairs Manager – International Compliance Operations will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This Regulatory Affairs Manager – International Compliance Operations will provide support for the regulatory department to ensure efficient and compliant business processes and environment. This position has responsibility for compliance activities for products and processes. The individual may execute tasks and play a consultative...