QA Compliance Lead Auditor (GCP) North Carolina area Remote Based

Fortrea•Durham, NC

1d•$70,000 - $125,000•Remote

About The Position

The QA Compliance Lead Auditor is a senior-level, US remote-based role within Fortrea’s Global Quality Assurance organization, with preference for candidates near Durham, North Carolina. The position provides regulatory expertise, leads complex GCP audits and inspections, and drives global quality initiatives. It serves as a regulatory subject matter expert, supporting internal teams, clients, and regulatory authority interactions to help ensure ongoing compliance and inspection readiness. The role contributes to global QA policy development; leads or participates in risk-based GCP audits; leads or supports audit and inspection hosting and response activities; leads quality metrics reporting; and participates in continuous improvement initiatives across the QA organization. It also acts as a backup to QA Management and supports operational reporting responsibilities.

Requirements

Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline; relevant and equivalent experience may be considered in lieu of formal education.
Fluency in written and spoken English.
Minimum 8 years of experience in a regulated environment, including GxP roles.
Demonstrated regulatory expertise with detailed knowledge of GCP and applicable global regulations.
Experience as a 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 that reduce inspection risks and strengthen inspection readiness.
Legally entitled to work in the US without employer-sponsored work permits; this position is not eligible for sponsorship.

Nice To Haves

Postgraduate degree (MSc or equivalent) in a scientific or management-related discipline.

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.