Seasoned Quality Assurance professional with experience in performing global GCP audits of clinical investigator sites, vendors, and internal systems/processes. In addition to audit experience, has extensive global health authority inspection experience, including Inspection lead role and conducting inspection risk assessments, preparing for and coordinates all GCP inspections (including routine, directed and submission related inspections i.e., FDA, MHRA, EMA, Health Canada, NMPA, TFDA, PMDA, etc.). Contributed to successful GCP inspections globally which have led to product approvals.