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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