"IT Compliance Lead"

Experience

• At least 7 years’ experience in pharmaceutical business processes with in-house and outsourced manufacturing and the associated IT solutions.
• At least 7 years’ experience dealing with pharmaceutical industry regulations and guidelines (including FDA 21 CFR Part 11, EU Annex 11, GxP, GAMP)
• 7+ years’ experience in a Computer Systems Validation role, with at least 3 years in a leadership role
• Experience in GxP inspections performed by regulating authorities
• Strong track record of contributing to projects and achieving results within a validated regulatory environment
• Experience working with IT validation document repository (ValGenesis), electronic signature solutions (Adobe and DocuSign), IT control management system (AuditBoard) and corporate quality management system (TrackWise and Veeva).
• A working knowledge of IT application development, implementation and support processes within a regulatory environment