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Fortrea is a contract research organization (CRO) that provides advanced laboratory-focused services that help change lives. On a mission to deliver “life-cha
QA Compliance Lead Auditor – GCP Auditor
Location
North Carolina
Posted
61 days ago
Salary
$105K - $120K / year
Seniority
Senior
Job Description
QA Compliance Lead Auditor – GCP Auditor
Fortrea
• Conduct risk-based end-to-end GCP audit activities • Provide GCP subject matter expertise and lead/influence the Clinical Development organization • Facilitate and review audit and inspection responses • Contribute to the development and interpretation of global QA policies • Support project teams in CAPA plan creation and execution • Lead or support reporting of quality metrics and trends via Monthly Reports • Manage or participate in global Quality initiatives aimed at improving compliance and efficiency • Deliver audit-related training
Job 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
- Fluent in English, written and verbal
- 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.
Benefits
- Medical, Dental, Vision, Life, STD/LTD, 401(K)
- Flexible time off (FTO)
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