Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements for laboratory systems and equipment (Understanding of data integrity principles and security controls including, but not limited to audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc). In this role, you''ll establish operational objectives, drive cross-functional alignment, and lead the full lifecycle of validation documentation - including System Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Test Scripts, and RTMs - in accordance with GAMP 5, 21 CFR Part 11, and FDA''s Computer Software Assurance guidance.