[Hiring] QA Compliance Lead Auditor @Fortrea

Role Description

The QA Compliance Lead 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.

• Contribute to global QA policy development.
• Lead and/or participate in conduct of risk-based GCP audits.
• Lead and/or support end-to-end audit/inspection hosting and response activities.
• Lead quality metrics reporting.
• Participate in continuous improvement initiatives across the QA organization.
• Act as a backup to QA Management and support operational reporting responsibilities.

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.

Requirements

• 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 understanding of Quality Management Systems (QMS), quality issue management, and CAPA processes.
• Strong strategic communication skills with clients and internal stakeholders.
• Experience leading or contributing to quality and process improvement initiatives reducing inspection risks and strengthening 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.

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

11/08/26