• Experienced professional in Pharmaceutical and healthcare compliance domain with wide experience in GXP, 21 CFR part 11, GAMP 5 and other compliance requirements and adherence.
• Specialist in Life Sciences IT Compliance/CSV with extensive experience in FDA (GxP, 21 CFR Part 11), and other regulations.
• Over 10 years of experience in providing tactical direction and guidance for project teams implementing Computer Systems for new or existing GxP systems including the development and analysis of system requirements.
• Extensive experience in Global IT Quality systems creation, rollout and management including Global IT Policy, SOPs, Procedures.
• Experienced Program Manager with extens...