- Merck & Co. (Durham, NC)
- Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across the full value chain for a late-stage ophthalmic program. In this ... advise, problem-solve, and drive continuous improvementImplement and oversee fit-for-purpose Quality Management Systems and standard ways of... teamsRepresent Quality on the Value Chain Management Team and related working groups; lead … more
- Merck & Co. (Ames, IA)
- …and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below ... aspects of the Supplier Quality Management (SQM) and Animal Health global...through ongoing training and continuing education programs.Coordinate with Site Quality leads on audit refusals and postponements. Lead … more
- Merck & Co. (Rahway, NJ)
- …COMMUTABLE DISTANCE AND BE ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end ... Business System Owner (BSO) of the current Documentum-based global submission content management solutionCo- lead the implementation of the next generation Veeva… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Patient Services Quality & Process leads quality assurance and ... training, and data-driven optimization aligned with Insmed's strategic goals.The Associate Director , Patient Services Quality & Process is responsible for… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and ... strategic direction for the clinical project management functions in a technology-driven, AI-focused biotech environment. This individual will be responsible for… more
- Repligen (Waltham, MA)
- …contribution drives progress. Join us!About the RoleRepligen is seeking a hands-on, strategic Director of IT & OT Infrastructure to lead the design, ... to business strategy, while overseeing internal teams, MSPs, and vendors to ensure high- quality , secure, and reliable services.You will lead and develop a… more
- Insmed Incorporated (San Diego, CA)
- …of science, we're in. Are you?About the Role:We're looking for an Associate Director , Clinical Scientist for the Gene Therapy Clinical Development team to help us ... what's possible for patients with serious diseases. Reporting to the Executive Director , Clinical Development, you will support and work predominately with the… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global regulatory ... development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical functions and will act… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Executive Director of Metabolism & Obesity will be responsible for overseeing and facilitating the research in metabolic diseases & obesity and ... data science, while focusing on uncovering novel biology that delivers high- quality drug discovery pipeline.-We are a research-driven biopharmaceutical company. -Our… more
- Insmed Incorporated (NJ)
- …compliance with regulatory requirements while maintaining operational excellence. The Executive Director , Cybersecurity & Risk Management plays a critical ... seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role will manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Medical Director responsible for Communication Strategy and Medical Program Management on tracking and management of budget.Support Head of Publications- ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes Global Medical and ... systems globally. The ability to successfully participate in and lead cross-functional teams is a critical part of this...is a critical part of this role. The Executive Director has scientific and budgetary oversight for all outcomes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trained, following process and SOPs. The Director will ensure the Senior Director , Clinical Operations (Asset Lead ) is fully informed of the overall ... mitigations in place. The Director can be an extension to the Asset Lead when needed and serve as an SME (Subject Matter Expert) on applicable Study Managment… more
- Merck & Co. (Rahway, NJ)
- …Negotiation, Optical Microscopy, Product Commercialization, Production Process Development, Project Management , Prototyping, Quality Management Systems ... Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our… more
- Insmed Incorporated (NJ)
- …through Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including ... of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC...cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive Quality input into… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Associate Director , Patient Services Partner Relations oversees key vendor partnerships that support ... service excellence, compliance, and alignment with Insmed's strategic goals.The Associate Director , Patient Services Partner Relations is responsible for leading and… more
- Merck & Co. (Rahway, NJ)
- …oversee GMP environmental monitoring and microbiological release of pipeline products.- The director will provide guidance, lead activities, and strengthen a ... formulations, and their processes for non-sterile and sterile products. The Director will also collaborate with Development Quality , Pharmaceutical Operations,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborating with GxP Quality representatives across the organization Quality Management and Continuous Improvement: Lead effective communication ... Management Process for the respective business areas.Responsibilities:Leadership and Project Management : Lead the end-to-end quality execution across… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …strong knowledge of regulatory frameworks (eg, FDA), GCP guidelines, and quality management systems.Preferred but Not Mandatory: Medical practice experience ... OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to ... the main point of contact and support all signal management activities. They will lead the safety...as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool… more
