GxP Systems Administrator

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.

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:

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

Required Skills, Experience and Education:

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  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.
  
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  Direct experience administering GxP quality and regulatory platforms.
  
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  Basic understanding of industry guidelines (GAMP 5) and US/international regulations (FDA, ICH, ISO, EU) for GxP systems.
  
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  Knowledge of user management, including security access controls, policies, and permissions.
  
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  Experience providing system support, including troubleshooting and resolving user issues.
  
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  Efficient time management, with the ability to support multiple systems simultaneously.
  
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  Strong written and verbal communication skills and the ability to present complex information.
  
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  Ability to work effectively in a dynamic and fast-paced environment.
  

Preferred Skills:

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  Veeva Vault White Belt certification or 2+ years’ experience configuring Veeva Vault systems.
  
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  Direct experience administering and configuring Veeva Vault (Quality, RIMS), eTMF (Trial Interactive), DocuSign Part 11 and Lorenz Docubridge.
  
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  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.
  
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  Familiarity with Azure Entra and Active Directory.
  
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  Basic scripting or automation skills (e.g., Python, PowerShell) to support system efficiency.
  
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  Experience collaborating with Quality and Regulatory teams within a GxP environment.