Validation and Assurance Strategy: Lead planning, execution, review, and approval of validation and assurance deliverables for new GxP systems, system upgrades, integrations, infrastructure changes, software changes, and system retirements, Determine appropriate validation or assurance rigor using risk-based principles aligned with GAMP 5, CSA, data integrity, e-record/e-signature, and applicable GxP expectations, Lead or review system risk assessments, validation strategy assessments, supplier/vendor assessments, impact assessments, and validation planning decisions, Ensure validation strategies are proportionate to system risk, intended use, business process impact, patient/subject safety, product quality, data integrity, and regulatory impact. CSV/CSA Deliverables: Author, review, or approve validation lifecycle deliverables, including system risk assessments, validation plans or assurance plans, URS, functional/design/configuration specifications, IQ/OQ/PQ or functional testing protocols, regression testing, UAT evidence, traceability matrices, validation summary reports, periodic reviews, change impact assessments, data migration, archival, decommissioning, and retirement documentation, Ensure validation documentation is complete, accurate, traceable, reviewable, and inspection-ready, Provide quality and technical review of deliverables prepared by project teams, IT system owners, vendors, and less senior CSV/CSA resources.