GXP Systems Specialist

Key Responsibilities

• Data Migration & System Administration: 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.
• Computer System Validation (CSV): Manage and execute the full validation lifecycle for systems utilized in clinical trials, ensuring complete technical compliance with regulatory expectations.
• Regulatory Compliance: Ensure all system activities, data transfers, and technical processes strictly align with GAMP guidelines and GCP regulations.
• eQMS Support (Extension): Provide auxiliary support and system optimization for Oak Hill Bio’s Electronic Quality Management System using ACE Software (by PSC) as project timelines permit.
• Cross-Functional Collaboration: Report directly to the Senior Director, QMS and Clinical QA, and partner closely with the IT Quality Lead and Project Lead to ensure smooth data transfer operations.

Qualifications

• Proven CSV Experience: Strong background in Computer System Validation (CSV) specifically within the biotech, pharmaceutical, or life sciences industries.
• Technical System Depth: Demonstrated system administrator-level experience with Box, Ignite, and SharePoint. Experience transferring data from Electronic Trial Master Files (eTMFs) is a strong plus.
• Regulatory Knowledge: Deep understanding of GAMP guidelines and GCP regulations regarding systems used in clinical trials.
• eQMS Exposure: Prior hands-on experience or familiarity with ACE Software (by PSC) is highly desirable.
• Adaptability & Execution: Ability to hit the ground running in a fast-paced, 12-week sprint, delivering accurate technical results with minimal ramp-up time.
• Communication: Strong technical communication skills to seamlessly align with IT Quality and Project leadership.

Additional Details

• Position Type: 12-Week Contract (Short-term sprint)…