Author, review, and approve computerized system validation deliverables, including protocols, test scripts, reports, risk assessments, deviations, and technical documentation, using a risk-based approach and ensure laboratory computerized systems comply with data integrity and electronic records and electronic signatures requirements, including 21 CFR Part 11, EU Annex 11, ALCOA++, and applicable global, regional, and site procedures. Monitor and communicate system health, compliance risks, project status, service performance, and quality metrics to Quality leadership and relevant stakeholder and serve as a subject matter expert during regulatory inspections, client audits, and internal audits for LIMS, analytical instrument systems, computerized system lifecycle controls, and laboratory data integrity.