- Merck & Co. (Rahway, NJ)
- …compliance and operational excellence in the laboratories. Maintains a state of inspection readiness . Performs proactive resourcing planning and risk assessment ... Communication, Decision Making, Dosage Forms, GMP Compliance, Immunochemistry, Innovation, Inspection Readiness , Learning New Concepts, Manufacturing, Microbiological… more
- Merck & Co. (Rahway, NJ)
- …excellence in the laboratories, and for maintaining a state of inspection readiness at all times. The Director should be well engaged with regulatory ... Communication, Cross-Functional Teamwork, Decision Making, Dosage Forms, GMP Compliance, Inspection Readiness , Medical Device Management, Medical Device… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …into an annual Quality Plan, including quality risk assessments and inspection readiness components for designated programs.Ensure proactive representation of ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...during inspections and external audits. Ensure ongoing submission and inspection readiness for the respective Medical Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study oversight and execution.Ensure their direct reports are maintaining a state of inspection readiness across all activities on their study and making sure ... measures in place to course correct where needed. The Director will be accountable to support SDL and employee...reports are properly trained, following process and SOPs. The Director will ensure the Senior Director , Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical Review Prospective & Retrospective Quality Review of cases Regulatory Intel & Inspection Readiness Maintains up to date knowledge of the regulations and ... you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers...reports pertaining to Novo Nordisk Products. The Medical Review Director is a key Leadership Team member and advisor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of continuous improvement in benefit-risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual will be the main ... cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE)...a global and regional level as required.Support audit and inspection readiness activities as a subject matter… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sites. In addition, this role will support Compliance initiatives, such as inspection readiness , metrics implementation and review, overall regulatory compliance ... landscape to stay informed of regulatory trends and developmentsAssist with inspection readiness efforts and program implementation across all sites.Manage… more
- Merck & Co. (Rahway, NJ)
- …GMP Auditing, GMP Compliance, GMP Operations, Good Manufacturing Practices (GMP), Inspection Readiness , Quality Auditing, Quality Management, Quality Management ... Job DescriptionThe USDA Compliance Subject Matter Expert (SME) - Associate Director , will report to the Animal Health Global Quality Compliance and Technical Lead.--… more
- Merck & Co. (Rahway, NJ)
- …and execution of design verification strategies, and design transfers for testing readiness , which includes incoming and release tests for components and combination ... employees at all levels to effectively engage and coordinate the implementation/ readiness and execution of design verification tests and methodologies in support of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applicable regulatory requirements, and other relevant guidelines.Is accountable for inspection readiness of DM programming documentation filed/archived ... areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management… more
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