- Insmed Incorporated (San Diego, CA)
- … Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and ... regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team,...agency inspections and vendor audits.Ability to ensure that a strategic audit plan is developed, designed and implemented, and… more
- Merck & Co. (Rahway, NJ)
- …Operational Strategies, Outsourcing, Process Improvements, Production Scheduling, Project Management Planning, Quality Compliance , Regulatory Compliance {+ 3 ... establish boundaries and ground rules for engagement with the EPs, while ensuring compliance / quality readiness of these suppliers at all times through the… more
- Merck & Co. (Rahway, NJ)
- …be responsible for upskilling GCS in the applications used for reporting.- The Associate Director , BI&A will help in driving the strategic performance of the ... and WW regulations, company policies and Standard Operating Procedures.The Associate Director , Business Insights and Analytics (BI&A), is responsible for Developing… more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) ... controls for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... vision to influence the regulatory environmentWill be responsible for sub-functional strategic planning, coordinating, and execution of initiatives for the Company's… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (Durham, NC)
- …The successful candidate will be responsible for managing or supporting strategic projects designed to improve overall warehouse operations and efficiency.- ... routine internal and external GMP and Financial audits, QSAT actions, to ensure compliance .- This is a fast-paced and multi-faceted role that provides leadership and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Marketing and Sales to develop strategies and tactics that will Improve strategic planning Expand and improve the quality of clinical research Increase ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....they and their team act in complete and total compliance with all laws, regulations and policies. Responsible for… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic ... and mitigate risks. The ideal candidate has deep experience in procurement, strategic sourcing, and vendor management within the biotech, pharmaceutical, or life… more
- Tris Pharma (Monmouth Junction, NJ)
- …control systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality , and regulatory standards in warehouse ... in our Monmouth Junction, NJ facility for an experienced, hands-on SR. Director / Director , Procurement. Title and salary commensurate with experience. The … more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and ... relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in shaping ... with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing interface with key… more
- Twist BioScience (South San Francisco, CA)
- …are seeking an experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization ... MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance, and R&D. The Director will serve as the… more
- Merck & Co. (Durham, NC)
- …Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization ... compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control).-… more
- Eisai, Inc (Exton, PA)
- …supporting technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing scientific ... close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …high-performing team while ensuring compliance with legal standards. The Director will drive informed decision-making and strategic alignment through ... in? Are you ready to experiment with us? The Position The Director , Market Intelligence and Portfolio Insights will leverage Competitive Intelligence methodologies… more
- Twist BioScience (South San Francisco, CA)
- Twist Bioscience is seeking a strategic and execution-oriented Director or Senior Director of Business Development (title commensurate with experience) to ... and execution of signed partnerships, maximizing their impact on business goals. Compliance & Quality :Ensure all activities comply with applicable regulatory… more
- Formation Bio (New York, NY)
- …role in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and ... faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision ... within R&D. Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cutting-edge AI/GenAI technologies and developing AI/GenAI products to deliver high quality insights with speed and efficiency Promotes a culture of creativity ... the Novo Nordisk US Operations, including ED&AA, IT, Ethics and Compliance , Commercial, Patient Services, CMR (Clinical, Medical, Regulatory), Finance, and Novo… more
