CSV Manager, Quality Systems Technology (QST)
Corcept TherapeuticsRedwood City, California, United States
Posted April 1, 2025
154100 - 181300 USD year
Full Time
About the Company
Corcept Therapeutics innovates in modulating cortisol's effects for various health conditions.
Job Description
Corcept is seeking a Computer Systems Validation (CSV) Manager to lead continuous improvement initiatives for its Quality Management System (QMS) and support enhancements to validated GxP systems. This is a hybrid position requiring on-site presence 3 days per week.
Requirements
- 8+ years' experience in the development and maintenance of quality systems in clinical and commercial-stage pharmaceutical companies
- Deep knowledge of ICH Q10 & GAMP 5, 21 CFR Part 11 and Annex 11
- Familiarity with risk-based computer system validation (CSV/CSA) strategies
Benefits
- competitive salary range ($154,100 - $181,300)
- opportunity to work with a team dedicated to discovering and developing novel treatments for patients with serious unmet medical needs
