- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the ... Quality team based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and Strategy role is an exempt level position with… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director /Senior Director , Clinical Quality Assurance. This is a hybrid ... position. Job Title commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides… more
- Merck & Co. (Durham, NC)
- …and Alum/Sterile Supply) and cross-functional teams (ie Maintenance, Global Engineering, Quality , and Technical Operations) to ensure a successful design, technology ... comprehensive technology transfer of the HPV vaccine Purification area while ensuring compliance with all regulatory and safety guidelines.Lead a diverse team and be… more
- Tris Pharma (Monmouth Junction, NJ)
- …builds in-house analytical capabilities, when needed. The incumbent ensures timeline, quality and compliance with applicable Standard Operating Procedures ... guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , AR&D serves as Deputy to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Development SOP Management Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... centered around rare diseases and immune disorders. Job Summary: The Director , Development SOP Management is responsible for providing strategic direction, planning,… more
- Merck & Co. (Durham, NC)
- …stabilization. The Associate Director will ensure optimized product quality and manufacturing processes, regulatory compliance , employee and environmental ... Job DescriptionGENERAL SUMMARYThe Associate Director - Fermentation Technology Lead within our Bulk Facility Technical Operations organization will be responsible… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director /Senior Director , the ... support of their assigned projects. Position Description- The Principal Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance ... Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before...with delivery lead eg review TLG before DBL, and quality check of data, Works with BD&O to ensure… more
- Merck & Co. (Rahway, NJ)
- …sustained launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Program Leadership ... Job DescriptionJob Summary: -The Director of Device Technology Transfer is a key...team members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance:Ensure that all activities… more
- Merck & Co. (South San Francisco, CA)
- …are seeking an exceptional and experienced leader in the role of Director Discovery Biologics, Protein Sciences and Analytical Characterization within the Discovery ... Biologics at our South San Francisco site.- The Director will be responsible for the leadership of a...the head of a group responsible for delivering high quality characterization data to advance discovery programs from the… more
- Aequor (Waltham, MA)
- Job description Job title - Director , IT Operations, and Infrastructure Location - Waltham, MA 02451 Permanent fulltime role Hybrid role - 3 days onsite, 2 days ... remote Position Summary: The IT Operations Director will oversee the operation of server systems, networking equipment, cloud platforms, and GxP environments,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory ... duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately....Practices. Proactively identifies compliance risks impacting research unit across DSG, and assures… more
- Merck & Co. (Rahway, NJ)
- … mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' ... collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion.Operational Strategy: Develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes ... tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, International… more
- Merck & Co. (North Wales, PA)
- …data capabilities and data products. The role influences and ensures timely and high- quality value delivery across all aspects of the data value chain including but ... Data Mastering, Data Governance including but not limited to Data Marketplace, Data Quality , Data Risk Management c) Value Realization with use of these Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... (CROs) for multiple projects and ensures timely delivery of high quality deliverables at reasonable cost. Identify/develop tools for efficient vendor management.-… more
