GXP Systems Specialist

Role Responsibilities:

• Actively manage and execute a short-term, Box-to-Box data transfer project into Oak Hill Bio.
• Maintain system administrator responsibilities for SharePoint, Ignite, and Box.
• Manage and execute the full validation lifecycle for systems utilized in clinical trials.

Regulatory Compliance:

• Ensure all system activities, data transfers, and technical processes align with GAMP guidelines and GCP regulations.
• Provide auxiliary support for the Electronic Quality Management System using ACE Software.
• Report directly to the Senior Director, QMS and Clinical QA.

Qualifications:

• Proven background in Computer System Validation (CSV) within biotech or pharma.
• System administrator-level experience with Box, Ignite, and SharePoint.
• Strong understanding of GAMP guidelines and GCP regulations.