QA Compliance Lead Auditor North Carolina Us Remote Based

The **QA Compliance Lead Auditor (GCP Auditor)** 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, leading 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 participates in conduct of risk-based GCP audits, supports audit hosting and inspection 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** * Conduct risk-based end-to-end GCP audit activities, i.e., process, service provider/vendor, clinical investigator site, study, for cause audits. * Provide GCP subject matter expertise and lead/influence the Clinical Development organization by providing guidance and client/authority facing support on specific niche regulatory topics to internal stakeholders, project teams and clients. * Facilitate and review audit and inspection responses, including oversight of CAPA development and implementation. * Contribute to the development and interpretation of global QA policies related to regulatory requirements. * Support project teams in CAPA plan creation and execution. * Support QA‑to‑QA relationships with key strategic clients. * Lead or support reporting of quality metrics and trends via Monthly Reports, Quality Reviews, and Liaison Meetings. * Manage (for area of expertise) or participate (for multi‑regulatory topics) in global Quality initiatives aimed at improving compliance and efficiency. * Deliver audit‑related training, including basic, intermediate, and complex audit methodologies. * Act as backup to the QA Manager as required and provide monthly activity reporting. * Ensure Regulatory Compliance and Quality Assurance (RC & QA) responsibilities defined in applicable controlled documents are followed. * 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 $105,000-$120,000** **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: July 24, 2026** #LI-SE1 #remote Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).