Experience leading validation deliverables for GxP systems and computer system validation (CSV) and computerized system assurance (CSA) activities across the shop-floor systems lifecycle (L2 to L6), including validation plans, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) protocols, summary reports, user requirements specifications, functional specifications, design specifications, traceability matrices, risk assessments, test strategy and execution, deviation management, final reporting, and release approval. Lead computer system validation (CSV) and computerized system assurance (CSA) deliverables across the shop-floor systems lifecycle (L2 to L6), including risk assessments, validation planning, requirements traceability, test strategy and execution, deviation management, final reporting, and release approval.