Yvonne Lee

With over 18 years of experience in the pharmaceutical and contract research organization (CRO) industries, Yvonne Lee is a Quality Assurance professional specializing in corporate compliance, clinical operations, and global auditing. She has strong expertise across GxP domains, including GCP, GcLP, GMP, GDP, and GPvP, as well as Quality Management Systems (QMS), CAPA, and SOP-driven process improvements.

Yvonne has conducted over 50 audits across Asia-Pacific, Europe, and North America, both remotely and on-site. Her experience includes Investigator Site Audits, Pharmacovigilance Audits, Process Audits, Computer Systems Validation (CSV), and a wide range of Vendor Audits, along with regulatory commitment verification and mock inspections.

Currently serving as Quality Assurance Manager for the APAC region, she is recognized for her detail-oriented approach, regulatory expertise, and commitment to quality and continuous improvement in clinical research. She holds a degree in Clinical Medicine.