QA Compliance Lead Auditor – GCP Auditor

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🔥 15 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $105k - $120k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• 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.

🎯 Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. • 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. • Fluent in English, written and verbal. • Applicants must be legally entitled to work in US without the need for employer-sponsored work permits.

🏖️ Benefits

• Medical • Dental • Vision • Life • STD/LTD • 401(K) • Flexible time off (FTO)