Auditor is an accomplished Quality Assurance professional with over 150 domestic and international quality audits, specializing in pharmaceutical and medical device industries. He possesses expertise in FDA and international regulations, Quality Management Systems, Pharmacovigilance, Computer System Validation, Data Management, and Vendor/Supplier Management. He has held key roles in organizations like Good Clinical Consultants, Boston Scientific Corporation, and i3, conducting audits and providing compliance assistance. His educational background includes a B.Sci in Biology and Chemistry and an M.S. in Clinical Trial Administration. He holds multiple certifications, including Certified Quality Auditor and Certified Clinical Research Professional. He is an active member of professional associations such as the American Society for Quality and Society of Quality Assurance. His extensive experience and qualifications make him a valuable asset in ensuring regulatory compliance and quality within the industry.