- 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
- 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
- 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
- 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)
- …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
- 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)
- …FDA Compliance, FDA GMP, FDA Inspections, FDA Regulatory Requirements, Inspection Readiness , Pharmaceutical Development, Pharmaceutical IndustryPreferred Skills: ... Job DescriptionDirector - Global Quality Auditing and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and… more
- Insmed Incorporated (NJ)
- …training to ensure consistent and compliant execution across Patient Services.Lead audit readiness and inspection management for internal QA, client, and ... the future of science, we're in. Are you?About the Role:The Associate Director , Patient Services Quality & Process leads quality assurance and process improvement… 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
- 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
- Insmed Incorporated (NJ)
- …closely with our QA organization to implement and manage a process for Inspection Readiness .Contributes to the development and review of regional/global policies ... 1-2 indications within one compound, in collaboration with the Senior Director , Clinical Operations. Ensures consistent and successful execution of operational… 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
- Bristol Myers Squibb (Princeton, 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
- J&J Family of Companies (New Brunswick, NJ)
- …Johnson & Johnson is currently recruiting for a IM PD Asset Management Readiness Lead! This position can be located in New Brunswick, Titusville or Raritan, ... and patients._ The Innovative Medicine (IM) Project Delivery (PD) Asset Management Readiness is part of the Project Delivery Technical Support Group (TSG), that… 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
- Taiho Oncology (Princeton, NJ)
- …Deviations, Corrective Actions and Preventive Actions (CAPAs). + Responsible for supporting inspection readiness related to GVP. + Support Taiho Global GXP ... Pharmaceuticals Co., Japan, TCAN. TPOC, and TPAC as needed. + Support inspection readiness activities including audits and inspections conducted by external… 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
- Bristol Myers Squibb (Madison, NJ)
- …manage regulatory inspections, applying principles of Quality Risk Management to ensure inspection readiness and compliance. Assist in the review and preparation ... lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Executive Director , Cell Therapy Quality Compliance, is responsible for ensuring robust… more
- Merck (Rahway, NJ)
- …FDA Compliance, FDA GMP, FDA Inspections, FDA Regulatory Requirements, Inspection Readiness , Pharmaceutical Development, Pharmaceutical Industry **Preferred ... **Job Description** ** Director - Global Quality Auditing and Supplier Management** The Director will report to the Animal Health Global Quality Lead for… more
