Senior Manager, Computer System Validation QA

Role: Senior Manager, Computer System Validation (CSV), QA at BridgeBio overseeing validation lifecycle for GxP systems to ensure compliance with regulatory standards. Responsibilities: provide QA oversight of GCP/GVP computer system validation from design through retirement, review risk assessments, change controls, validation deliverables, participate in audits, support inspection readiness, and drive continuous improvement of QMS and validated systems. Collaborate with IT, quality, and functional stakeholders; support AI governance and training. Requirements: Bachelor’s/Master’s in software, engineering, or technical field; 8+ years in quality systems within clinical or biotech/pharma sectors; expertise in GxP CSV/CSA, system lifecycle management, and relevant regulations (21 CFR Part 11, GAMP, ICH GCP). Preferred: experience with AI/LLMs, and working knowledge of data integrity, clinical practice, and pharmacovigilance requirements. High-Value: focus on GxP computerized systems, validation in clinical and commercial drug development, with a need for cross-functional influence. Work setup: remote with quarterly onsite travel to San Francisco; salary range $145,000-$170,000 USD.