- 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)
- …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
- 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)
- …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
- 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
- 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)
- …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)
- …required to assure compliance with PV agreements. Participate in audit and inspection readiness activities. Provide input for remediating PV system deficiencies ... cited in audit/inspections. Implement effective corrective and preventative action PV Agreements and Contracts: Manages PVAs/SDEAs and maintains oversight of PV relevant contracts. Oversee and set standards for PV contract management. Review contribute to… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and quality delivery and regulatory compliance of outsourced activities.- Ensures inspection readiness of all data management activities conducted internally ... areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the vision,… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to ensure departmental KPIs and regulatory compliance are consistently met Audit & Inspection Readiness Support the preparation and execution of internal and ... external audits and regulatory inspections Ensure documentation and processes are audit-ready and aligned with global pharmacovigilance standards Physical Requirements 0-10% travel required. Development Of People Supervisory. Verbiage below applies only to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and ensure appropriate documentation Perform case follow-up activities Participate in inspection readiness and support audits/ inspection as required ... of assigned projects in Patient Safety. Relationship Reports directly to the Director , Patient Safety Case Management. This role involves the case handling and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …templates meet both Global and local regulatory requirements Supports audit and inspection readiness Develops and maintains company (safety) SOPs Business ... with SDEA requirements. Relationships This position reports to the Associate Director , Safety Contracts & Supplier Management. This position works closely with… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Director of Inspection Readiness is responsible for ensuring ... cell therapy, and medical device operations. Reporting to the Senior Director of Inspection Readiness , this individual contributor role leverages extensive… more
- Merck (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
- Merck (Rahway, NJ)
- …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
- Bristol Myers Squibb (Madison, NJ)
- …strategies and roadmaps that align with business priorities, regulatory requirements, and inspection readiness . By leading Communities of Practice and driving ... of core PV processes within your assigned L2 pillar, ensuring effectiveness, inspection readiness , and alignment with regulatory requirements, industry best… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …activities, in partnership with risk program and SMEs. + Support the overall inspection readiness of the GVP Audit program, including preparation for and ... Join Gilead and help create possible, together. **Job Description** The Associate Director , Good Pharmacovigilance Practice (GVP) Audits, serves as a key role within… more
