- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of robust vendor management oversight plans and establishes a comprehensive interface for risk and issue management.Support GCO Quality by Design, risk ... functions, to ensure a community of practice centered on Quality by Design, Clinical Trial Risk Management,...centered on Quality by Design, Clinical Trial Risk Management, efficient Issue Management, and Continuous Improvement. Metrics… more
- Insmed Incorporated (San Diego, CA)
- …to the Executive Director of Program Management, the Associate Director , Program Management supports the cross-functional drug development ... will drive the development, creation, and implementation of high quality , global, coordinated cross-functional project plans for products in...in accordance with the program strategy. In addition, the Associate Director of PM may be asked… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description Associate Director , Automation The Associate Director Manufacturing Automation is responsible for managing the team ... guidance/support for key review and approval of automation incidents, Quality Notifications (QNs), system commissioning and qualification, change control, and… more
- Merck & Co. (Rahway, NJ)
- Job Description- The Associate Director operates under the guidance of the Technical Engineering and Technology Directors supporting Line of Business (Biologics, ... Operations and Safety), Engineering Firms and Vendors to progress deliverables. The Associate Director would be responsible for leading planning, design, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and ... policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for...to develop a strategy to help address facilitation of risk -based periodic review/update cycles specifically for identified high- risk… more
- Merck & Co. (Rahway, NJ)
- …tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with ... and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …of the MACS EDFE Leader include the following:The EDFE Leader role at the Associate Director level will serve as a technical mentor and process team ... manufacturing plant currently planned in Rahway, New Jersey. The Associate Director will serve as a team...compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific… more
- Merck & Co. (Rahway, NJ)
- …and make informed decisions to manage their parts of the Research & Development division.The Associate Director , PMO People & Process Lead, is a unique role that ... Job DescriptionAssociate Director , PMO People & Process LeadGlobal Project and...the training forum; accountable for curating and defining a quality annual calendar of topics that achieve the purpose… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quantitative and qualitative means. Candidate will define Key Performance Indicators, Key Quality Indicators, Key Risk Indicators, and other targeted operational ... metrics in collaboration with R&D Line Functions. Candidate will establish internal and external benchmarks to inform future planning and target setting. Candidate will oversee the build and governance of a Metrics Library with clear definitions and thresholds… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the... of data is suitable for regulatory submission. The Associate Director will have routine interaction with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and productivity.Key Responsibilities Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Quality Plan together with the supported CSPV teams, including the quality risk assessments and inspection readiness components for the designated ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports...along the GvP modules in support of a proactive quality risk management process.Interact with the audit… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time and within budget. The position holder ... skills in continuous improvement, project management, change management and risk management.Responsibilities Project level AI/ML activities - Responsible, with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also ... require proven skills in continuous improvement, project management, change management, and risk management. The position will act as main statistical contact for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... launch.- The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build a culture… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management. He/she will assess project issues and develop resolutions to meet ... smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior… more
- Aequor (Thousand Oaks, CA)
- …and/or AKTA chromatography, and data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for a product team as the ... and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Quality Management Systems. offers the opportunity… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of research and strategic partnership contracting agreements. In collaboration with the Associate Director , the Associate Manager will support CMR's ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function… more
- Merck & Co. (Rahway, NJ)
- …a fast-paced job that provides both technical and project management responsibility. The Associate Specialist - Engineering Auto Eng position will report to the ... Director , Engineering, Automation Lead position and will be a...process control systems to improve production efficiency and product quality .Collaborate with cross-functional teams, including operations, maintenance, and … more
- Merck & Co. (Durham, NC)
- …procedures and business plan - Receives guidance and oversight from Operations Associate Director and DirectorInterprets client and/or customer needs and ... that Shift(s) objectives are achieved while reliably supplying a quality product at a competitive cost consistent with our...and any action plans to address gaps to the Associate Director and/or Director -… more
