QA Compliance Lead Auditor (GCP Auditor) REMOTE

Fortrea•Durham, NC

1d•$105,000 - $120,000•Remote

About The Position

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.

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.
Fluent in English, written and verbal.
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.

Nice To Haves

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.

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.