QA Compliance Lead Auditor (GCP Auditor) REMOTE

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.

The role contributes to global QA policy development, leads and/or participates in conduct of risk-based GCP audits, leads and/or supports end-to-end audit/inspection hosting and 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 and lead risk-based, end-to-end GCP audits, including process, service provider/vendor, clinical investigator site, study, and for-cause audits.
• Provide GCP subject matter expertise and regulatory guidance to internal stakeholders, project teams, and clients, including client- and regulatory authority-facing support as appropriate.
• Coordinate and host sponsor qualification and routine audits, regulatory inspections, for-cause audits, and other external audit activities.
• Serve as a primary QA point of contact throughout the audit and inspection lifecycle, supporting readiness, request management, document and system access, SME and interview coordination, and issue escalation.
• Facilitate and review audit and inspection responses, including assessment and challenge of responses, corrective actions, and CAPAs to ensure they adequately address reported observations.
• Track audit and inspection commitments, CAPAs, supporting evidence, and follow-up activities through completion and closure, escalating significant or overdue items as appropriate.
• Maintain a strong working knowledge of the Quality Management System (QMS) and support the timely progression, tracking, escalation, and closure of quality issues and associated CAPAs .
• Support QA-to-QA relationships with key strategic clients.
• Lead or support quality metrics, trend reporting, Quality Reviews, and global Quality initiatives focused on compliance, consistency, and efficiency.
• Contribute to the development and interpretation of global QA policies and ensure activities are conducted in accordance with applicable regulatory requirements and controlled documents.
• Deliver audit-related training and provide cross-training, mentoring, and coaching to auditors, audit hosts, and audit support staff, as appropriate.
• Maintain current professional and technical knowledge through continuing education, regulatory guidance, relevant publications, and professional networks.
• 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 understanding of Quality Management Systems (QMS), quality issue management, and CAPA processes, including tracking issues and actions through timely resolution and closure.
• ·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 $70,000-$125,000

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: 11/08/26

Originally posted on Himalayas