QA Compliance Lead Auditor (Host) North Carolina / US Remote Based

This is a senior-level, US remote-based role with preference for candidates near Durham, NC. The position sits within Fortrea’s Global Quality Assurance organization and serves as a regulatory subject-matter expert, hosting complex GCP audits and inspections while driving global quality initiatives.

Responsibilities

• Coordinate and host business-development, sponsor-qualification, routine-sponsor audits, regulatory inspections, and for-cause audit activities, including scheduling, agendas, request lists, SME coordination, and preparation of audit/inspection support materials.
• Serve as the primary point of contact for external auditors, sponsors, inspectors, internal stakeholders, and operational teams throughout the audit or inspection lifecycle.
• Support operational-team readiness before, during, and after external audits and inspections, including preparation meetings, document collection, interview coordination, and issue escalation.
• Facilitate audit and inspection activities as host, support, or coordinator, ensuring requested documentation, systems access, and subject-matter experts are available in accordance with applicable procedures.
• Manage receipt, triage, review, and internal routing of external audit reports, including coordination of stakeholder review, finding assessment, response ownership, and timelines.
• Review and challenge external audit responses, corrective actions, and CAPAs to ensure they are adequate, complete, clearly supported, aligned with procedural expectations, and responsive to the reported observations.
• Track external audit commitments, responses, CAPAs, evidence, and follow-up actions to support timely completion, closure, and appropriate escalation of overdue or quality-critical items.
• Support regulatory inspection readiness and for-cause audit coordination by compiling requested information, maintaining audit/inspection records, and providing status updates to leadership and relevant stakeholders.
• Assist with cross-training, mentoring, coaching, and/or supervision of auditors, audit hosts, or audit support staff as required.
• Maintain professional and technical knowledge through continuing education, review of relevant guidance and publications, and participation in professional networks; contribute to team objectives and perform other duties as assigned.
• Contribute to the development and interpretation of global QA policies related to regulatory requirements.

Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline; relevant and equivalent experience may be considered in lieu of formal education.
• Fluent in English, written and verbal.
• Minimum 8 years of experience in a regulated environment, including GxP roles.
• Demonstrated regulatory expertise with detailed knowledge of GCP and applicable global regulations.
• Experienced 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.

Preferred Qualifications

• Postgraduate degree (MSc or equivalent) in a scientific or management-related discipline.
• Legally entitled to work in the US without employer-sponsored work permits; this position is not eligible for sponsorship.

Work Environment

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional domestic and international travel.

Physical Requirements

• Frequently stationary for 6–8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15–20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

Pay

USD $100,000–$115,000 / annual

Benefits

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including:

• Medical, Dental, Vision, Life, STD/LTD
• 401(K)
• Flexible time off (FTO)