Senior Manager, Computer System Validation QA
Job in
New York, New York County, New York, 10261, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, IT QA Tester / Automation
Job Description & How to Apply Below
Role
Senior Manager, Computer System Validation (CSV), QA at Bridge Bio 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
- 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)
- experience with AI/LLMs
- working knowledge of data integrity, clinical practice, and pharmacovigilance requirements
- focus on GxP computerized systems, validation in clinical and commercial drug development, with a need for cross‑functional influence
- remote with quarterly onsite travel to San Francisco
- salary range $145,000-$170,000 USD
Position Requirements
10+ Years
work experience
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