3h ago
GxP Systems Administrator
Redwood City, California, United States
full-timemidPharmaceuticals / Biotechnology
Tech Stack
Description
You will provide day-to-day administration and support for GxP-compliant SaaS systems (especially Veeva Vault) that enable R&D functions at a clinical-stage oncology company. Your role includes managing user access, troubleshooting issues, supporting system implementations, and ensuring compliance with regulations like 21 CFR Part 11 and GAMP 5.
Requirements
- Bachelor's degree and 2+ years IT experience supporting GxP environments in pharma/life sciences
- Veeva Vault Platform Administrator certification (or ability to obtain within 6 months)
- Hands-on experience administering Veeva Vault applications (QualityDocs, QMS, RIM)
- Knowledge of user management, security access controls, and permissions
- Experience with ServiceNow for system support and troubleshooting
Responsibilities
- Administer and support GxP systems in compliance with 21 CFR Part 11, Annex 11, GAMP 5
- Manage user access provisioning, modification, and deactivation for GxP systems
- Troubleshoot and resolve support requests using ServiceNow
- Perform periodic user access reviews, audit trail reviews, and other steady-state tasks
- Support implementation and maintenance of new GxP systems, including validation activities
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