Quality Assurance and Compliance Specialist with 14+ years of progressive experience within the pharmaceutical/ biotech industry. Area of expertise includes assuring laboratory compliance (GLP/ GMP/ GCP/ISO/WHO) for sample testing. Specializing in auditing quality and technical operation policies and procedures to verify compliance. Experience working in virtual, international and multi-site environments with persons of varied backgrounds and cultures. Understanding of 21 CFR 11, 58, 210, 211, 820; ICH Q8, Q9, Q10; ISO 15189, 17025, and 19011.