GXP Systems Specialist

About Frontier

Frontier is a subsidiary of Fresh Prints. Fresh Prints is a New York-based, fast-growing, fully remote, 150-person company with most of our team based in India and the Philippines. A few years ago, Fresh Prints began helping other fast-growing companies build their teams. We got so good at it that we spun out a new company to focus exclusively on that — and called it Frontier.

At Frontier, we help companies grow full-time, cross-functional teams abroad. We hire the smartest people and place them into the best companies. In three years, we’ve never lost a client. If you’re interested in a Frontier role and you apply and are accepted, we’ll screen you through a couple of internal interviews and aim to get you an interview for a full-time job within the month.

Think of us as your personal talent agent — and good luck with the application! 😊

About Oak Hill Bio

Oak Hill Bio is a clinical-stage, rare disease therapeutics company focused on developing life-changing treatments for patients with urgent unmet needs. We are passionate about translating cutting-edge science into meaningful therapies and building a collaborative culture that drives innovation and impact.

Role Overview

We are seeking a highly skilled GXP Systems Specialist for a focused, 12-week contract to lead a critical data migration project and support our broader quality systems. The primary focus of this role is a Box-to-Box data transfer into Oak Hill Bio, alongside ensuring robust Computer System Validation (CSV) in compliance with life sciences regulatory frameworks. The ideal candidate will possess deep system administrator experience across SharePoint, Ignite, and Box, coupled with a solid understanding of clinical trial system regulations.

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)
• Location: Fully Remote
• Working Hours: 10:00 AM to 6:00 PM GMT (Monday – Thursday)