- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operations expertise including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit , or equivalent experience.Must have expertise with ... rare diseases and immune disorders. Summary: Accountable to organize and directs an audit universe for GMP relevant activities involving but not limited to supplier… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …required).Ensure audit observations are communicated, tracked, and remediated in compliance with internal policies and procedures as well as with all applicable ... treatment of multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality team based...and support the implementation of the internal and external audit program.Schedule, execute, report and follow-up on internal and… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Associate Director , Medical Review Committee (MRC) Operations is responsible for managing the operational ... execution of the company's Global We're looking for an Associate Director , Medical Review Committee Operations, on the Medical Review team to help us expand what's… more
- Merck & Co. (Rahway, NJ)
- …clinical supplies to clinical sites across more than 60+ countries, in compliance with worldwide regulations, company policies and standard operating procedures.The ... Director , Technical Operations Planning is a strategic team leader...of working.Lead a team of technical experts responsible for:CSO Compliance OperationsCSO Integration OperationsGlobal Site SchedulingProcess ownership, KPIs, investigations… more
- Insmed Incorporated (NJ)
- …and asset operations, and workplace safety.This position will advise the Executive Director , Facilities on all aspects of EH&S compliance , performance, and ... future of science, we're in. Are you?About the Role:The Director , EHS (Environmental, Health, and Safety) isa senior-level role... training, environmental compliance , health and safety compliance , and audit performance and compliance… more
- Insmed Incorporated (NJ)
- …Management and Boards of Directors .Strong understanding of risk management, compliance , and audit processes within regulated industries, ideally biotechnology ... program. This role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive… more
- Insmed Incorporated (NJ)
- …Investigator Brochures, and handling guidanceSupport Clinical Supply Chain to ensure compliance with eTMF documentation and audit readiness activitiesSupport ... and for the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position Assist Director of Institutional Contracts in managing the development and implementation of 340B as ... well as Inflation Reduction Act ("IRA") processes and compliance activities for the Medicare Drug Negotiation Program. Ensures accurate and timely input and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the pharmaceutical or biotechnology industry. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations or the ... Director , GxP Compliance , Patient Safety, & Vendor Oversight. This job will...established metrics Prepare and present regular reports on documentation compliance , audit results, and improvement initiatives to… more
- Insmed Incorporated (NJ)
- … compliance with document management standards, version control, and audit readiness.Coordinate the intake, formatting, and QC of regulatory documents prior ... possible for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for the publishing, management, and… more
