Quality Management System Specialist

About Frontier

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

Here at Frontier, we help companies grow full-time, cross-functional teams abroad. We hire the smartest people, and we place them into the best companies. In three years, we’ve never lost a client. 

If you like one of the Frontier roles, and you apply, and you’re accepted, we’ll screen you with a couple of internal interviews, and will work on getting 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 :)

One of our clients, Oak Hill Bio is looking to hire an QMS Specialist.

About The Role

Oak Hill Bio, a new biotech dedicated to developing life-changing medicines for rare and auto-immune diseases that impact patients across their lifespan, is looking for an experienced QMS Specialist. We are building a team of intelligent, hard-working, and collaborative individuals dedicated to bringing these therapies to patients in need. Oak Hill Bio is a fast-growing firm offering the opportunity for extraordinary professionals to take on a major responsibility and drive results. 

QMS Specialist – Position Summary

The QMS Manager will play a critical role in maintaining Oak Hill Bio’s Quality Management System (QMS), with a strong focus on Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) compliance. This position is ideal for a self-starter QA professional with GxP experience, who thrives in a fast-paced, cross-functional environment and is motivated by a mission-driven culture.

Key Responsibilities:

Quality System Oversight & Compliance

• Maintain and update QMS documentation including SOPs, policies, and templates in alignment with global GCP and GMP regulations under the direction of the Senior Director, QA.
• Manage deviation tracking, implement CAPAs, and ensure up-to-date quality logs.
• Oversee ACE eQMS system and ensure all GCP and GMP QA documentation is filed and up to date.
• Maintain eQMS records received from CMC and Clinical Supplies.

Audit Management

• Compile annual audit plan for GXP vendors.
• Coordinate and manage internal and external audits focused on GCP and GMP, according to the annual audit plan.
• Review audit reports, track resolution of findings, and oversee CAPA execution by auditees (internal and external).

Vendor Qualification

• Maintain the Approved Vendor List.
• Maintain Vendor Qualification records in the eQMS.
• Ensure all vendor documentation and quality agreements are up to date and filed in the eQMS.

Inspection Readiness

• Administrative support of GCP inspection preparedness activities, organizing training, documentation review, and site visit support.
• Support QA execution of the inspection plan when inspections are announced and preparation of responses to inspection findings.
• Ensure compliance with regulatory expectations.

Training Record Management

• Maintain training compliance metrics.
• Deliver training sessions on GCP and quality best practices to cross-functional teams.
• Monitor and provide compliance advice in relation to the QMS.

Quality Metrics & Reporting

• Maintain metrics for audit, vendor qualification, CAPA and deviations, and other outputs of the Quality Management System.
• Prepare metric reports from the eQMS for quality management review meetings.

Qualifications:

• Bachelor’s degree in life sciences or a related field.
• 2-5 years’ experience in Quality Assurance within the clinical research or pharmaceutical industry, with a primary focus on GCP or GMP.
• In-depth knowledge of global GCP (Clinical development QA or compliance) and/or GMP regulations or specialist knowledge in CMC compliance.
• Strong organizational, interpersonal, and communication skills.
• Proven ability to manage multiple projects and collaborate with diverse stakeholders.
• Attention to detail and meticulous record keeping skills.
• CSV experience and data integrity knowledge a plus.

Why Join Oak Hill Bio?

This is an opportunity to make a meaningful impact at a company committed to scientific innovation and patient-focused development. You’ll work alongside experienced leaders in a supportive and forward-thinking environment.