Generate, obtain approvals for, and execute validation deliverables for computerized systems and supporting infrastructure - including Validation Plans, Test Plans, User and Functional Requirements, Installation/Operational/Performance Qualification (IQ/OQ/PQ) test scripts, Traceability Matrices, Test Summary Reports, and Validation Summary Reports - ensuring documents meet the regulatory and procedural requirements of 21 CFR Part 11, Annex 11, data integrity, and GAMP 5, among others. In this role, you will provide senior-level leadership and hands-on expertise across the qualification and validation of GxP-regulated computerized systems and IT infrastructure throughout the computerized system lifecycle, ensuring compliance with applicable regulatory requirements, Computer Systems Validation (CSV) and lifecycle procedures, and data integrity principles.