Executive Director, GCP Quality Assurance

Job description

SUMMARY/JOB PURPOSE: The Executive Director, GCP/GVP QA, is accountable and responsible for defining and implementing an end-to-end GCP/GVP QA strategy and direction, as well as implementing and maintaining an effective cross-functional GCP/GVP Inspection Readiness program. This position leads and develops a team of GCP QA professionals and collaborates with functional embedded compliance roles to assess company compliance and quality across GCP and GVP functions, systems, and activities. Integrates quality by design throughout functional and cross-functional GCP and GVP processes, and a risk-based approach to associated audits; supports cross-functional Quality Risk Management (QRM) processes to identify, track, and mitigate risk within GCP/GVP, develops, tracks, and trends key metrics to inform risk-based decisions, and collaborates with functional representatives to manage patient safety and clinical data integrity and reliability risks through support of functions and QA oversight activities. In addition, this position drives GCP/GPV Inspection Readiness initiatives internally and serves as the coordinator for the Inspection Readiness Governance Council (IRGC), partners with cl...