A pharmaceutical quality assurance professional with 22 years of diverse and comprehensive experience in GCP, GLP, GCLP, GVP, cGMP and CSV activities of drug development. Proven record of accomplishments in the implementation of successful Inspection Readiness (IR) programs and successful management of regulatory inspections leading to positive outcomes in inspections conducted by USFDA, EMA, ANVISA, WHO, MoH Turkey, DCG(I), OECD GLP, ISO 17025, ISO 15189.Skills: • Audits - Good Clinical Practice (GCP), Good Laboratory Practice (GLP/GCLP), Good Manufacturing Practices (cGMP).• Quality Management Systems and Learning Management Systems implementation and management.• Management and auditing of External Service Providers, CROs and CMOs.• Development and Management of Inspection Readiness Programs.• Hosting and Management of Regulatory Agency Inspections (DCG(I), USFDA, EU, ANVISA and other international agencies).• Computer System Validation of Combined instruments and stand-alone applications at user end - MasterControl eDMS, Veeva eQMS, ComplianceWire eLMS, eLN, Watson LIMS.Audits:• 50+ regulatory inspections successfully hosted leading to positive outcomes.• Hosted 200+ sponsor audits for GCP/GLP/cGMP.• Conducted 50+ site audits for GCP/GLP/GCLP/GVP/cGMP (Pre-Clinical, Phase 1 to Phase 3 clinical studies ) – Investigator sites, vendors, suppliers, and CSV audits..