Career Center

Head/Associate Director, GCP Auditing & CAPA Mgt (Hybrid) Location:  Cambridge, MA (Hybrid role,) or Zurich, Switzerland   About the role: Manage the CQA GCP Audit Operations team (5 - 7 FTE and contractors). Establish processes and standards for excellence in GCP audits, responses, CAPAs and effectiveness checks to optimize effective and consistent performance within CQA and for R&D clinical trial stakeholders. Conduct and/or manage the audits of R&D clinical studies and ensure effective risk mitigations are established. Interpret CQA quality audit metrics to identify and communicate compliance risks and liaise with R&D and R&D Quality functions to drive or