QA Compliance Lead Auditor – GCP

🕒 July 21

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $70k - $125k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 45%

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

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 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 • Support client- and regulatory authority-facing activities • 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 • Support readiness, request management, document and system access, SME and interview coordination, and issue escalation • Facilitate and review audit and inspection responses, corrective actions, and CAPAs • Track audit and inspection commitments, CAPAs, supporting evidence, and follow-up activities through completion and closure • Maintain knowledge of the Quality Management System and support progression, tracking, escalation, and closure of quality issues and CAPAs • Support QA-to-QA relationships with key strategic clients • Lead or support quality metrics, trend reporting, Quality Reviews, and global Quality initiatives • Contribute to development and interpretation of global QA policies and ensure regulatory compliance • Deliver audit-related training and provide cross-training, mentoring, and coaching • Maintain current professional and technical knowledge through continuing education, regulatory guidance, publications, and professional networks • Perform other related duties as assigned

🎯 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 • 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 • Legally entitled to work in the US without employer-sponsored work permits; position is not eligible for sponsorship • Postgraduate degree (MSc or equivalent) in a scientific or management-related discipline (preferred) • Ability to access and use in-house and off-the-shelf computer software • Regular and consistent attendance • Varied hours may be required

🏖️ Benefits

• Medical • Dental • Vision • Life insurance • Short-term disability (STD) • Long-term disability (LTD) • 401(K) • Flexible time off (FTO)

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