The Auditor, a seasoned regulatory and quality assurance professional, has over 20 years of experience in FDA-regulated medical product research and development, GXP compliance, and FDA project management. They have held key roles both in the public and private sectors, including positions at the US FDA and various pharmaceutical companies in the United States. With a Master's degree in Endocrinology and Physiology from University Laval in Canada, the Auditor has demonstrated expertise in implementing risk-based quality approaches, leading regulatory inspections, and ensuring compliance with Good Clinical Practice (GCP) standards. They bring a wealth of knowledge in areas such as regulatory affairs, medical writing, clinical quality assurance, and risk management. The Auditor's extensive background and dedication to excellence make them a valuable asset in their current role as Senior Director of GCP Quality Assurance at Stealth Biotherapeutics, based in Needham, Massachusetts, USA.