- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in design (and resolution) of ... knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience working with drug-device… more
- Merck & Co. (Rahway, NJ)
- …more productive and enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position will report to ... partners, user experience researchers, engineers, and data scientists to assess value risk , usability risk , feasibility risk and business viability… more
- Merck & Co. (Rahway, NJ)
- …Management Section of the GCS Planning organization.- Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic ... Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.-Responsible and accountable… more
- Merck & Co. (Rahway, NJ)
- …the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines,- strategies and… more
- Merck & Co. (Rahway, NJ)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... supplies.-Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and IT etc.Ensures contracts include the appropriate terms and conditions for cost, quality , payment terms, timelines, and mitigates any risk ; while ensuring all ... execution.Leads all aspects of strategic sourcing to ensure best value (cost, quality , Account Mgmt, timelines) for the businesses. Performs in-depth bid analysis… more
- Novo Nordisk Inc. (Durham, NC)
- …confirmation on shop floor Ability to support all processes & functions in Department Quality Risk Management Make decisions on quality & compliance issues ... & process confirmation on shop floor & improvement of Quality processes. Relationships Reports to Manager , QA....Part 11, GAMP5, ISO, Data Integrity preferred Experience with Risk Assessment & Vendor Assessments required Minimum of four… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM ... of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires...Lead the team to develop and implement metrics including Quality Tolerance Intervals, Key Risk Indicators, Key… more
- Merck & Co. (Durham, NC)
- …Review Meetings (with External Partner).-- Compliance:-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk ... investment requirements, and provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner… more
