- Merck & Co. (Durham, NC)
- Job Description- The Associate Director of Quality Systems provides leadership, focus, and governance to the Hilleman site in the following Quality Systems: ... Deviation Management, Complaints, Corrective Action/Preventive Action Management, Annual Product Review Authoring, Quality Risk Management, and Quality … more
- Merck & Co. (North Wales, PA)
- …execution for successful delivery across various teams and vendor partners to meet product line objectives with high quality , timeliness, and within budget / ... drives results.Reporting to the HH IT US Data Services Product Line Leader, this role will be responsible for...data products. The role influences and ensures timely and high- quality value delivery across all aspects of the data… more
- Merck & Co. (Rahway, NJ)
- …the Position The Animal Health IT Customer Master Data Management (MDM) Product Owner collaborates with stakeholders across all levels of the organization, from ... that balances user desires with technology capabilities.Develop and maintain product materials, including training documentation, SDLC documentation, and product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team resources, issues, risks as well as achieving overall project level quality metrics. An ideal Associate Director , Program Management must have ... centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for effectively planning,… more
- Merck & Co. (Rahway, NJ)
- …development and GMP clinical supply manufacture of our Company's drug product pipeline.- The FLEx Process Engineering Lead drives process development expertise, ... formulators and device engineers to develop robust and innovative drug product manufacturing processes.- Close partnership with colleagues from Formulation Sciences,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Business Systems and Process Improvement leads procurement efficiency and continuous improvement initiatives within Animal Health ... like RPA, Celonis, and AERA. Reporting to the Vice President of AH-GSM, the Director is a key member of the leadership team driving digital transformation withing… 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, ... Supplements (PAS, CBE-0, CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Job Summary: The Director , Diagnostic Sciences will be responsible for end-to-end process for CDx ... forms, scoring forms, and DTS documentsDevelops and implements a testing quality monitoring program, ensures consistent data monitoring and output across the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes Process Best Practices: ... serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise ... plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions… more
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , Quality Assurance - Analytical,GMP has responsibility for the ... approval of GMP analytical records. Will also provide QA support for GTx Quality Control laboratories. This position is onsite/hybrid and based in San Diego,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval ... for assigned project(s).Strategize and plan for FDA meetings for assigned product . Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics ... vendor management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Lead the definition of solutions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate ... or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics ... vendor management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Work with User Support Leads… 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
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new ... and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal stakeholders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to multiple aspects of the ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal and budget.… more
