Role OverviewThe QA Compliance Lead Auditor (Host) 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, hosting complex GCP audits and inspections, and driving global quality initiatives.
What You Will Do
Coordinate and host business development, sponsor qualification, routine sponsor audits, regulatory inspections, and for-cause audit activities, including scheduling, agendas, request lists, SME coordination, and preparation of audit/inspection support materials.
Why It Might Be a Fit
The position requires a regulatory subject matter expert (SME) with strong critical thinking and risk-based assessment skills, experience leading or contributing to quality and process improvement initiatives, and a strong strategic communication skills with clients and internal stakeholders.
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.
- Fluent in English, written and verbal.
Benefits
- Medical
- Dental
- Vision
- Life
- STD/LTD
- 401(K)
- Flexible time off (FTO)
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