GxP Systems Administrator

GxP Systems Administrator

W2 Contract-to-Hire

Location: Redwood City, CA - Hybrid Role

Job Summary:

The GxP Systems Administrator will be responsible for the day-to-day support and administration of application platforms that enable our Research & Development (R&D) functions. The ideal candidate will have hands-on experience administering GxP-compliant SaaS systems, with a focus on user management, system access, and operational support, along with a strong understanding of regulatory requirements in a life sciences environment.

Duties and Responsibilities:

• Administer and support GxP systems that enable R&D functions in compliance with applicable regulations and standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5).
• Manage user access for GxP (and occasionally non-GxP) R&D platforms, including provisioning, modifying, and deactivating user accounts.
• Troubleshoot and resolve support requests and incidents related to GxP systems in a timely and precise manner.
• Collaborate with cross-functional teams (e.g., Quality, Regulatory, Clinical, IT) to support business operations and ensure compliance.
• Perform routine system activities such as periodic user access reviews, audit trail reviews, and other steady-state tasks per company procedures and regulatory standards.
• Support the implementation and maintenance of new GxP systems, including validation activities and system documentation (e.g., specifications, user guides, administration procedures).

Requirements and Qualifications:

• Bachelor's degree or equivalent in a relevant field (e.g., Information Technology, Computer Science) with experience supporting GxP-regulated environments, in pharma, life sciences, or related industries.
• Direct experience administering GxP quality and regulatory platforms.
• Basic understanding of industry guidelines (GAMP 5) and US/international regulations (FDA, ICH, ISO, EU) for GxP systems.
• Knowledge of user management, including security access controls, policies, and permissions.
• Experience providing system support, including troubleshooting and resolving user issues.
• Efficient time management, with the ability to support multiple systems simultaneously.
• Strong written and verbal communication skills and the ability to present complex information.
• Ability to work effectively in a dynamic and fast-paced environment.

Preferred Qualifications:

• Veeva Vault White Belt certification or 2+ years' experience configuring Veeva Vault systems.
• Direct experience administering and configuring Veeva Vault (Quality, RIMS), eTMF (Trial Interactive), DocuSign Part 11, and Lorenz DocuBridge.
• In-depth understanding of Computer System Validation (CSV) principles, Software Development Life Cycle (SDLC) processes, and 21 CFR Part 11 compliance, with applied experience in validation documentation and ensuring regulatory adherence.
• Familiarity with Azure Entra and Active Directory.
• Basic scripting or automation skills (e.g., Python, PowerShell) to support system efficiency.
• Experience collaborating with Quality and Regulatory teams within a GxP environment.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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