Provide strategic quality eadership for Computerized System Validation (CSV) and Computer Software Assurance (CSA), including risk-based validation approaches, system changes, upgrades, integrations, data migrations, and periodic reviews. Serve as the Digital Systems QA SME for regulatory inspections and audits, maintaining inspection readiness and monitoring evolving FDA, EMA, PMDA, GAMP 5, 21 CFR Part 11, EU Annex 11, data integrity, CSA, and AI-related regulatory expectations.