QA Compliance Lead Auditor North Carolina Us Remote Based

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 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 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** #LI-SE1 #remote Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).