QA Compliance Lead Auditor (GCP Auditor) NC BASED - REMOTE

Fortrea Holdings Inc.

Job Overview

Location

2 Locations

Job Type

Full-time

Full Job Description

📋 Description

• The QA Compliance Lead Auditor (GCP Auditor) is a senior-level remote role based in the US with preference for candidates near Durham, NC, serving as a regulatory subject matter expert within Fortrea’s Global Quality Assurance organization to ensure ongoing compliance and inspection readiness.
• Day-to-day responsibilities include conducting risk-based end-to-end GCP audits across processes, service providers, clinical investigator sites, and studies; providing GCP expertise to internal stakeholders and clients; facilitating audit and inspection responses; overseeing CAPA development and implementation; contributing to global QA policy development; leading quality metrics reporting; delivering audit-related training; and acting as backup to QA Management.
• The role sits within Fortrea Holdings Inc.’s Global Quality Assurance team, supporting internal teams, clients, and regulatory authority interactions to drive global quality initiatives and improve compliance and efficiency across clinical development operations.
• The person in this role will deepen their expertise in GCP and global regulations, lead high-impact audit activities, influence quality and process improvement strategies, and develop leadership capabilities in regulatory compliance, stakeholder communication, and cross-functional QA collaboration.

🎯 Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline (relevant equivalent experience may be considered)
• Minimum 8 years of experience in a regulated environment, including GxP roles
• Demonstrated regulatory expertise with detailed knowledge of GCP and applicable global regulations
• Proven experience as a Lead GCP Auditor with strong critical thinking and risk-based assessment skills
• Strong strategic communication skills with clients and internal stakeholders
• Experience leading or contributing to quality and process improvement initiatives that reduce inspection risks and strengthen inspection readiness

🏖️ Benefits

• Comprehensive benefits package including Medical, Dental, Vision, Life, STD/LTD, and 401(K) for full-time or part-time employees working 20+ hours per week
• Flexible time off (FTO)
• Remote work arrangement with preference for candidates near Durham, NC
• Occasional domestic and international travel to site locations
• Opportunity to lead global quality initiatives and serve as a regulatory SME within a growing clinical research organization

Skills & Technologies

GCP

Senior

Remote

$105k-120k

Degree Required

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Fortrea Holdings Inc.

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About Fortrea Holdings Inc.

Fortrea is a global contract research organization spun out from LabCorp in 2023 to provide drug development services across Phases I-IV. It offers clinical trial management, patient access solutions, regulatory consulting, and commercialization support to biopharmaceutical, medical device, and diagnostic clients. The company operates in more than 90 countries with 19,000 employees, leveraging therapeutic expertise in oncology, rare diseases, neuroscience, and other complex areas to accelerate therapies from lab to market while prioritizing patient experience and data-driven insights.

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