GxP Systems Administrator

The Opportunity:

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 and configuring GxP-compliant SaaS systems (particularly Veeva Vault), including basic security updates, object configuration, and lifecycle and workflow management, along with a strong understanding of regulatory requirements in a life sciences environment.

This individual will play a key role in handling user requests, provisioning accounts, troubleshooting issues, and supporting the implementation and maintenance of new GxP applications and systems. Strong technical skills, attention to detail, and the ability to communicate effectively across functional teams are essential for success in this role. As a member of the Information Sciences team, the GxP Systems Administrator will report directly to the Senior Manager, GxP Business Systems and collaborate closely with CSV, Quality, and other R&D stakeholders to ensure systems are effectively managed and remain in a validated state. Key responsibilities include:

• 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 occasional non-GxP) systems, including provisioning, modification, and deactivation of accounts per company procedures.

• Troubleshoot and resolve support requests and incidents related to GxP systems using ServiceNow, ensuring timely, accurate documentation and adherence to defined SLAs.

• 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).

• Participate in change control, impact assessments, and release management for validated systems.

• Maintain a working understanding of applicable GxP regulations and guidelines (e.g., 21 CFR Part 11, Annex 11, GAMP 5) and ensure data integrity principles (ALCOA+) are applied in day-to-day system administration and operations.

Required Skills, Experience and Education:

• Bachelor’s degree with a minimum of 2 years experience in Information Technology/Computer Science supporting GxP-regulated environments, in pharma, life sciences or related industries.

• Veeva Vault Platform Administrator certification required (or ability to obtain within 6 months of hire), with demonstrated hands-on experience administering and configuring Veeva Vault applications (e.g., QualityDocs, QMS and RIM).

• Experience supporting or administering Veeva Vault systems.

• Basic understanding of GxP regulatory expectations and industry guidelines (e.g., GAMP 5, FDA, EU).

• Knowledge of user management, including security access controls, policies, and permissions.

• Experience providing system support preferably using ServiceNow, 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.

• Experience with applications supporting life science research and development.

Preferred Skills:

• Direct experience administering and configuring Veeva Vault (Quality, RIMS), eTMF (Trial Interactive), DocuSign Part 11, ComplianceWire, and similar GxP systems.

• Working knowledge of Computer System Validation (CSV) principles and deliverables, Software Development Life Cycle (SDLC) processes, and 21 CFR Part 11 compliance, with applied experience in validation documentation and ensuring regulatory adherence.

• Familiarity with Active Directory and Azure Entra.

• Basic scripting or automation skills (e.g., Python, PowerShell) to support system efficiency.

• Experience collaborating with Quality and Regulatory teams within a GxP environment. 

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