QA Compliance Lead Auditor (GCP Auditor) North Carolina Hybrid Based

<p>The <b>QA Compliance Lead Auditor (GCP Auditor)</b> is a senior‑level role that is US remote based with <b><i><u>preference for candidates near Durham, NC location</u></i></b>. 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.</p><p>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.</p><p></p><p><b>Key Responsibilities</b></p><ul><li>Conduct risk-based end-to-end GCP audit activities, i.e., process, service provider/vendor, clinical investigator site, study, for cause audits.</li><li>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.</li><li>Facilitate and review audit and inspection responses, including oversight of CAPA development and implementation.</li><li>Contribute to the development and interpretation of global QA policies related to regulatory requirements.</li><li>Support project teams in CAPA plan creation and execution.</li><li>Support QA‑to‑QA relationships with key strategic clients.</li><li>Lead or support reporting of quality metrics and trends via Monthly Reports, Quality Reviews, and Liaison Meetings.</li><li>Manage (for area of expertise) or participate (for multi‑regulatory topics) in global Quality initiatives aimed at improving compliance and efficiency.</li><li>Deliver audit‑related training, including basic, intermediate, and complex audit methodologies.</li><li>Act as backup to the QA Manager as required and provide monthly activity reporting.</li><li>Ensure Regulatory Compliance and Quality Assurance (RC & QA) responsibilities defined in applicable controlled documents are followed.</li><li>Perform other related duties as assigned.</li></ul><p></p><p><b>Minimum Qualifications</b></p><ul><li>Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.<br><i>Relevant and equivalent experience may be considered in lieu of formal education.</i></li><li>Fluent in English, written and verbal.</li></ul><p></p><p><b>Required Experience</b></p><ul><li>Minimum <b>8 years</b> of experience in a regulated environment, including GxP roles.</li><li>Demonstrated regulatory expertise with detailed knowledge of <b>GCP and applicable global regulations</b>.</li><li>Experienced <b>Lead GCP Auditor</b> with strong critical thinking and risk-based assessment skills.</li><li>Strong strategic communication skills with clients and internal stakeholders.</li><li>Experience leading or contributing to quality and process improvement initiatives reducing inspection risks and strengthen inspection readiness.</li></ul><p></p><p><b>Preferred Qualifications</b></p><ul><li>Postgraduate degree (MSc or equivalent) in a scientific or management‑related discipline.</li></ul><p><i>Applicants must be legally entitled to work in US without the need for employer-sponsored work permits. This position is not eligible for sponsorship.</i></p><p></p><p><b><i>Work Environment:</i></b></p><ul><li>Work is performed in an office environment with exposure to electrical office equipment.</li><li>Occasional drives to site locations with occasional travel both domestic and international.</li></ul><p></p><p><b><i>Physical Requirements:</i></b></p><ul><li>Frequently stationary for 6-8 hours per day.</li><li>Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.</li><li>Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.</li><li>Ability to access and use a variety of computer software developed both in-house and off-the-shelf.</li><li>Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.</li><li>Regular and consistent attendance.</li><li>Varied hours may be required.</li></ul><p></p><p><b>Pay Range: USD $105,000-$120,000</b></p><p><b>Benefits: </b>All job offers will be based on a candidate’s skills and prior relevant experience, applicable <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">degrees/certifications,</span> as well as internal equity and market data. <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">Regular, full-time or</span> 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).</p><p><b>Application Deadline: June 12, 2026</b></p><p></p><p>#LI-SE1</p><p>#remote</p><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank" rel="noopener noreferrer">EEO & Accommodations request here</a><span>.</span></p>