- Ascendis Pharma (Palo Alto, CA)
- …with subject matter experts and senior management to formulate responses to audit /inspection findings relevant to GCP and GVP . + Responsible for the ... risk-based Quality Strategy, and maintenance of vendor qualification, global GCP and GVP processes, standards, and compliance monitoring systems. Responsible for… more
- BeiGene (San Mateo, CA)
- …processes and tools, and provide expertise and leadership in the areas of GCP/ GVP /GLP compliance of clinical development activities & operations. + Proactively ... GVP and GLP Inspection Management Teams and cross-functional compliance functions, in developing/adjusting adequate Inspection Readiness (IR) Plans and… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide mentorship and ... leadership for all aspects of quality and compliance . The incumbent will engage with key collaborators, build strategic partnerships working and collaborating… more
- Thrivent Financial (Minneapolis, MN)
- …uncovering and resolving multifaceted issues which may involve additional disciplines, including Senior Counsel, Internal Audit , and business line owners to ... region liaison to regulators and corporate auditors. + Partners with senior management and Compliance /Legal concerning internal investigations, member/client… more
- Lilly (Indianapolis, IN)
- …and Analytics (CDDA), Manufacturing, MQO, Global Quality Assurance Auditing & Compliance , Legal, and Ethics and Compliance ; and third-party organizations ... is responsible for partnering with Cell & Gene Therapy Senior Management within discovery, research, product development and manufacturing...and ensure operation in a manner such that all GCP/ GVP activities are followed. + The Sr Director is… more