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QA Compliance Lead Auditor (GCP Auditor) North Carolina Hybrid Based
- United States
- United States
Über
QA Compliance Lead Auditor (GCP Auditor)
is a seniorlevel 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 QAtoQA 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 multiregulatory topics) in global Quality initiatives aimed at improving compliance and efficiency. Deliver auditrelated 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 managementrelated 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 bebased on a candidate's skills and prior relevant experience, applicabledegrees/certifications,as well as internal equity and market data.Regular,full-timeor 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: June 2, 2026
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Sprachkenntnisse
- English
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