San Francisco, California
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Today
Responsibilities: Lead and manage CSV (Computer System Validation) for GxP systems across Quality, Manufacturing, Clinical, and Business areas. Develop and maintain validation procedures, templates, and master validation plans. Prepare and review validation documentation (plans, protocols, reports). Ensure compliance with GAMP 5, 21 CFR Part 11, and ISO 13485. Collaborate with cross-functional teams (IT, QA, Engineering, Manufacturing, Clinical). Support change control, audits, CAPA, and documen
Full-time