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

Job Location: Durham

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level

The QA Compliance Lead Auditor (Host) is a senior‑level role that is US remote based with preference for candidates near Durham, NC location.

This position is within Fortrea’s Global Quality Assurance organization, responsible for providing regulatory expertise, hosting complex GCP audits and inspections, and driving global quality initiatives. This position serves as a regulatory subject matter expert (SME), supporting internal teams, clients, and regulatory authority interactions to ensure ongoing compliance and inspection readiness.

Key Responsibilities

• Coordinate and host business development, sponsor qualification, routine sponsor audits, regulatory inspections, and for-cause audit activities.
• Serve as a 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.
• Facilitate audit and inspection activities as host, support, or coordinator.
• Manage receipt, triage, review, and internal routing of external audit reports.
• Review and challenge external audit responses, corrective actions, and CAPAs.
• Track external audit commitments, responses, CAPAs, evidence, and follow-up actions.
• Support regulatory inspection readiness and for-cause audit coordination.
• Assist with cross-training, mentoring, coaching, and/or supervision of auditors.
• Maintain professional and technical knowledge through continuing education.
• Contribute to the development and interpretation of global QA policies.

Minimum Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Fluent in English, written and verbal.
• Minimum 8 years of experience in a regulated environment, including GxP roles.

Preferred Qualifications

• Postgraduate degree (MSc or equivalent) in a scientific or management‑related discipline.
• Applicants must be legally entitled to work in US without the need for employer-sponsored work permits.

Work Environment

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

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.

Pay Range

USD $100,000-$115,000 / annual

Benefits

All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. 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).

Application Deadline

August 21, 2026

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