QA Compliance Lead Auditor; GCP Auditor North Carolina Hybrid

Position: QA Compliance Lead Auditor (GCP Auditor) North Carolina Hybrid 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).

Final date to receive applications:
June 12, 2026

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