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

About this role

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. The role contributes to global QA policy development, leads and/or supports audit/inspection hosting and response activities, leads quality metrics reporting, and participates in continuous improvement initiatives across the QA organization. The position also acts as a backup to QA Management and supports operational reporting responsibilities.

Key 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 a primary point of contact for external auditors, sponsors, inspectors, internal stakeholders, and operational teams thro ughout 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 as appropriate; contribute to team objectives and perform other duties as assigned.  • Contribute to the development and interpretation of global QA policies related to regulatory requirements. • Perform other related duties as assigned.

Minimum Qualifications • 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.

Required Experience • 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 reducing inspection risks and strengthen inspection readiness.

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. 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 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. • 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 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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Learn more about our EEO & Accommodations request here .

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