- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial member of our team, responsible for spearheading risk management efforts in ... years of experience in pharmaceutical development, device development, device systems operations, quality management , or a related area. Strong knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsible to complete on paper basis audit and to monitor vendor performance management program . Support the issue and communication of audit plans, agenda ... documents that set strategy in QA GMP Audit processes for contribution of Quality Management System (QMS) establishment processes in collaboration with GMP … more
- Formation Bio (New York, NY)
- …driving near-term development milestones until steady-state ownership is established.Key ResponsibilitiesDiligence Program Management Lead and manage the ... faster and more efficiently.About the PositionFormation Bio is seeking an Associate Director, Program Management - Asset Diligence & Integration to partner with… more
- Merck & Co. (Rahway, NJ)
- …Devices Design, Negotiation, Process Manufacturing, Product Design, Production Process Development, Project Management , Quality Management Systems (QMS) {+ 4 ... to set tactical and strategic direction on programs they lead to ensure high quality products and...development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and… more
- Formation Bio (New York, NY)
- …the strategic development and operational management of Formation Bio's quality assurance program to support the growing drug development capabilities. ... and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the...requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …(APS benchmarking, Validation Lifecyle Responsibilities, OOS monitoring and trending program )Contribute to developing and/or improvements to quality systems ... multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based...process validation activities in support of the commercial Carvykti program both within Legend but also externally with our… more
- Terumo Medical Corporation (Somerset, NJ)
- …**Job Details/Responsibilities** Leading the development and execution of Clinical Risk Management Plans and Clinical Quality Plans for studies Conducting ... Clinical Quality Metrics and KPIs across studies Performing vendor management , including audits and issue escalation for clinical suppliers Advising clinical… more
- Formation Bio (New York, NY)
- …and clinical studies. Collaborate with cross-functional teams (Clinical Development, Regulatory, Program Management , etc.) to shape and refine Clinical ... faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the clinical… more
- Merck & Co. (Rahway, NJ)
- …and Change Management - The complexity of categories and projects require high quality project and program management skills and a proven ability to ... this category is more than ~$200M, and delivery of high- quality procurement performance and capabilities is expected as part...can be shared and adopted throughout our Company. Sourcing Management - Adopt, lead , and implement Sourcing… more
- Merck & Co. (Rahway, NJ)
- …Governance Management , Leadership, Oncology, Operational Excellence, Privacy Compliance, Quality Management , Risk Management and Mitigation, Risk ... D, Medical Sciences;MBA or innovation/entrepreneurial certification preferredRequired Skills: Academic Quality Improvement Program (AQIP), Biopharmaceutical Industry, Biopharmaceutics,… more
- Merck & Co. (Rahway, NJ)
- …observations.-- Facilitate equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities.- Provide capital project ... Operations, Process Engineering, Process Optimization, Product Formulation, Protocol Development, Quality Management , Regulatory Inspections, Reliability Management… more
- Merck & Co. (Rahway, NJ)
- … and ensure raw materials are ordered and available for manufacturing activities Lead data management activities related to communication through FLEx Scheduling ... (3) years' experience in a functional area, such as Operations, Management , Quality , Technical Operations, Technology, Engineering Preferred Experience and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... generation plans based on insights from the marketplace. This role may also lead the Core Medical Team, Project Team (co-chair), and National Advisory Board meetings… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …execution. In-scope contracts mainly include CDAs, MSAs, SOWs, short-form agreements, quality agreements, license agreements, and amendments. The role will be ... utilizing Procurement's Contract Lifecycle Management (CLM) platform on a daily basis and will...contract owners and requesters, SME reviewers in Legal, Safety, Quality , Compliance, Data Privacy, IT, etc. Will interact with… more
- Merck & Co. (Rahway, NJ)
- …Support, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance, Process Technologies, Production Efficiencies, Production ... selected candidate will be a key contributor to the Operational Readiness program with the purpose of establishing the procedures, documentation, and training… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning management systems.Knowledge of cGMP ... This individual will partner with Training team members in collaboration with management in Operations to support personalized cell therapy production through safe… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Execution Systems Lead and will be responsible for providing project management support to the development and administration of EBR and digital solutions at ... program plans. Having experience with global teams, budgetary management , resource planning, and fiscal awareness is preferred.Provide technical expertise of… more
- Terumo Medical Corporation (Somerset, NJ)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for ... drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of...to the company's procedure (ITSM, CHARM, etc.) for user management and role management . + Meet the… more
- Merck & Co. (Rahway, NJ)
- …relevant scientific discipline (Oncology preferred) or MD from a top ranked program , equivalent experience considered4+ years of strategy management consulting ... development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare as part of our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …IT, Clinical, Research, Operations, Patient Support Programs, and Digital Health Lead cross functional collaboration with internal colleagues, including those in ... assist outside counsel as required Perform other duties as assigned by senior management Provide Corporate Law Legal Support Provide legal support and counseling to… more
