- 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
- 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
- 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
- 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
- Sandoz Group AG (Princeton, NJ)
- …Performance Evaluations, Finance Acumen, Gmp Procedures, Goal-Oriented, Health Authorities, Inspection Readiness , Leadership, Logical Thinking, Major Incident ... personally. Join us as a Founder of our 'new' Sandoz! As the Associate Director , Market Product Quality you will be responsible for the execution of processes… more
- Endo International (Horsham, PA)
- …and related international regulations. + Quality systems, batch documentation, and inspection readiness + Technology transfer, including CMC documentation and ... and compliance objectives, ensuring the facilities are in a constant state of inspection readiness and compliant with regulatory agency requirements. + Ensures… 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
- Merck (West Point, PA)
- …globe. The Quality Compliance Director will drive FDA and global inspection readiness , oversee site internal audits and Health Authority reporting, design ... **Job Description** We are hiring a Quality Compliance Director to join the West Point Quality Assurance...systems. **Key responsibilities:** + Lead FDA and Health Authority inspection readiness and responses; coordinate mock inspections,… more
- Merck (West Point, PA)
- …in areas of expertise + Provide expertise in developing strategies for inspection readiness including working with Regulatory with relevant submissions for ... Trials Operations, Creativity, Cross-Cultural Awareness, Cross-Functional Teamwork, Diversity Programs, Inspection Readiness , Leadership, Lean Six Sigma (LSS),… more
- J&J Family of Companies (Titusville, NJ)
- …leadership and at governance meetings (eg TA governance, DC/IC). + Lead and ensure inspection readiness for program through risk identification and readiness ... more at https://www.jnj.com/innovative-medicine **We are searching for the best talent for Director , Program Delivery Leader - Post Approval Delivery Unit, to be… more
- Lilly (Branchburg, NJ)
- …provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly ... of a sterility assurance network or hub in global TSMS + Support inspection preparation and execution during health authority on-site or remote inspection … more
- J&J Family of Companies (Raritan, NJ)
- …to meet the portfolio objectives throughout the year. + Support regulatory inspection readiness , inspections, and CAPAs where relevant **Education and ... America **Job Description:** Johnson & Johnson, is recruiting for a Executive Director , Therapeutic Area Safety Head, Cardiopulmonary to be located in Raritan, NJ;… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Serve as mentor to other leads. + Ensure preparation for audit and inspection readiness + Ensuring diversity and inclusion in decision making, organization and ... Read more: careers.bms.com/working-with-us . **Position Summary** Position reports to the Director of Medical Communications within WWMH, of Global Medical Affairs… more
