• Oversee the PFM risk-based Computer System Validation planning and execution (e.g., Validation Plans, Requirements Traceability Matrix, IQ/OQ/PQ, UAT), aligned to 21 CFR Part 11, EU Annex 11, ICH E6(R3) GCP, GLP, and data integrity principles (ALCOA++). • Ensure all computerized systems are validated according to internal SOPs and regulatory expectations. • Maintain a robust risk-based approach to system validation and lifecycle management by assuring periodic review, change control, configuration management, and release readiness for validated systems. • Supports lifecycle controls from implementation through decommissioning. • Establish and enforce QA policies and procedures for PFM systems. Provides input to the Application Development Lifecycle (ADLC) processes to represent regulated technologies • Monitor compliance trends and implement continuous improvement initiatives. • Serve as the primary key liaison with regulatory agencies and third parties for system-related audits and inspections. • Supports the maintenance of inspection ready validation documentation • Partner with Security, Development, PMO, BRM, Business Analysts, DevOps, Clinical Ops, and Lab leaders to prioritize QA activities and embed quality into SDLC/DevOps pipelines • Act as a key liaison with regulatory agencies during inspections related to corporate systems. • Deliver training and coaching on validation, testing, and data integrity for system owners and study teams • Partake to the qualification of data/system service providers • Ensure accurate and timely documentation of validation activities, deviations, and corrective actions. • Provide regular compliance reports and metrics to senior leadership. • Maintain audit readiness for all corporate systems. • Collaboratively work with IT to respond to audit findings.