- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes and implements digital and technology tools to enable efficiency and compliance , including automation and generative AI.This role will have an opportunity ... technology entablements, and other projects to gain experience with compliance -related labeling activities. The candidate will gain hands-on experience managing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include contract owners and requesters, SME reviewers in Legal, Safety, Quality, Compliance , Data Privacy, IT, etc. Will interact with third-party vendors, and CLM ... completeness, accuracy; identify necessary SME reviewers such as Quality, Safety, Compliance , IT based on business understanding and risk assessment; collaborate… more
- Merck & Co. (Rahway, NJ)
- …and equipment performance to ensure robust operation while maintaining compliance with all current regulatory expectations.-Receives assignments, direction, and ... Optimization, Product Formulation, Project Management, Quality Control Management, Regulatory Compliance , Regulatory Issues, Safety Compliance {+ 5… more
- Eisai, Inc (Nutley, NJ)
- …The Senior Director oversees vendor qualification, governance frameworks, and compliance with ICH/GCP guidelines and local regulations, ensuring inspection readiness ... Collaboration is central, working closely with Finance, Legal, Regulatory & Compliance , IT Security, and Clinical teams to align outsourcing strategies with… more
- Eisai, Inc (NJ)
- …strategies that deliver cost efficiencies, enhance vendor performance, and ensure compliance with regulatory and corporate standards. This role manages CRO and ... processes and partner with Vendor Risk Assessment teams to ensure compliance with regulatory requirements and alignment with corporate objectives.Applies strong… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …shipping validation, and data integrity.Key ResponsibilitiesProvide quality and compliance oversight for computer systems validation, process validation, equipment, ... and evaluates quality processes and system standards to ensure compliance with applicable Legend standards, industry standards, and global regulations.Interacts… more
- Cipla (Fall River, MA)
- …Manufacturing/Packaging and partners with cross functional team members to ensure compliance and operational success through user focused documentation at InvaGen ... and process validation of API equipment and products in compliance with site SOPs and regulatory guidance. Autonomously leads...of a team. Capable of handling and participating in compliance and regulatory audits at the local and federal… more
- Insmed Incorporated (NJ)
- …program. This role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive ... consistent with NIST and FDA data protection standards.Partner with Legal, Compliance , Clinical Operations, Quality and R&D to proactively manage risk across… more
- Cipla (Central Islip, NY)
- …and Services, ensuring cost-effective purchasing while maintaining quality and compliance standards. This role involves supplier management, negotiation, rate ... Develop and maintain strong, professional relationships with suppliers/vendors to ensure compliance with quality standards and timely delivery of goods and services.… more
- Genmab (NJ)
- …do; and we work with integrity-we do the right thingOversee direct report compliance with the Genmab Code of Conduct, guidelines and all policiesResponsible for ... knowledge of FDAMA 114, 21st Century Cures Act, HIPAA and other compliance regulations and guidelines relevant to industry interactions with payers and population… more
