​Planet Pharma is seeking a GxP Systems Administrator to join the Information Sciences team supporting a client’s Research & Development functions. This individual will provide day-to-day administration, user management, and operational support for GxP-compliant SaaS platforms, working remotely on a contract basis. The administrator reports to the Senior Manager, GxP Business Systems, and collaborates closely with CSV and Quality teams.

• ​Location: Remote (Listed base location: Redwood City, CA)
• ​Employment Type: Contract
• ​Experience: Required experience supporting GxP-regulated environments in pharma, life sciences, or related industries.
• ​Focus: User access management, troubleshooting, implementation support, and ensuring regulatory compliance (21 CFR Part 11, Annex 11, GAMP 5) and the validated state of R&D systems.

​Key Responsibilities: Compliance and System Integrity

​The administrator is key to maintaining system integrity, regulatory adherence, and operational efficiency for R&D.

• ​System Compliance & Administration: Administer and support GxP systems in compliance with regulations like 21 CFR Part 11, Annex 11, and GAMP 5.
• ​User & Access Management: Manage user access for GxP (and occasionally non-GxP) R&D platforms, including provisioning, modifying, and deactivating user accounts.
• ​Support & Troubleshooting: Troubleshoot and resolve support requests and incidents related to GxP systems in a timely and precise manner.
• ​Routine Activities: Perform steady-state tasks such as periodic user access reviews and audit trail reviews per company procedures.
• ​Validation Support: Support the implementation and maintenance of new GxP systems, including validation activities and system documentation (e.g., specifications, user guides).
• ​Collaboration: Collaborate with Quality, Regulatory, Clinical, and IT teams to ensure systems are effectively managed and remain in a validated state.

​Required and Preferred Qualifications: GxP and Veeva

• ​Required: Direct experience administering GxP quality and regulatory platforms. Strong technical skills, attention to detail, and efficient time management. Basic understanding of GAMP 5 and US/international GxP regulations.
• ​Preferred Experience:
  • ​Veeva Vault White Belt certification or 2+ years’ experience configuring Veeva Vault (Quality, RIMS).
  • ​Direct experience administering eTMF (Trial Interactive), DocuSign Part 11, and Lorenz Docubridge.
  • ​In depth understanding of Computer System Validation (CSV) principles, SDLC, and 21 CFR Part 11 compliance.
  • ​Basic scripting or automation skills (Python, PowerShell).