Sr. QA Computer System Validation Mgr.

Role: Senior QA Computer System Validation Manager overseeing GxP computer systems in GCP, GMP, and GLP environments within a biotech company developing late-stage therapeutics, including Phase 3 assets for retinal diseases and cystic fibrosis. Responsibilities: provide QA oversight of validation lifecycle, review CSV deliverables, manage external vendor activities, ensure compliance with FDA, EMA, ICH, and GAMP 5 standards, support audits and inspections, and collaborate cross-functionally to improve systems and processes. Requirements: Bachelor's in life sciences, computer science, or related field; 5-7 years biopharma experience, with at least 4 years in QA CSV supporting clinical trials and validated systems like IRT, EDC, and eTMF; deep knowledge of 21 CFR Part 11, EU Annex 11, data integrity, and regulatory standards; strong communication and stakeholder engagement skills. HighValue: supporting clinical systems in late-phase development, compliance with global regulations, validation of critical clinical systems, and cross-functional partnership. WorkSetup: less than 5% travel; primarily office-based.