Organization / Workplace
Raleigh-Durham, North Carolina Area United States
Associate Director, IT - Infosario Delivery Excellence & Assurance at Quintiles
Medical / Health Care / Pharmaceuticals
Over 15 years of IT/QA experience in project management, auditing and computer system validation in highly regulated environments (Pre-clinical/clinical/Manufacturing) for large to medium pharmaceutical/biotech companies. BS in Computer science + MA in Computer Info. Mgmt. Expert in US FDA 21CFR Part 11, EU GMP Annex 11, and GAMP compliance and strong working knowledge with GMP/GLP/GCP. Strong experience with full SDLC including IQ/OQ/PQ protocol creation, validation master planning, testing root cause analysis of system software errors after release to production, writing non conformance and investigation reports, corrective and preventive action, change control, risk assessment, imp...