Senior Manager, Computer System Validation QA
$145k - $170kScorpion Therapeutics
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 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 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 #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 4 days ago
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