Senior GCP Audit Lead — Remote QA Compliance Expert

FTINC Fortrea Inc.; North Carolina; À distance; USD 70 000 - 125 000; Plein temps

Résumé du poste

Fortrea is seeking a senior QA Compliance Lead Auditor for a US‑remote role with preference near Durham, NC. You will provide regulatory expertise, lead complex GCP audits, and support inspections, with accountability for audit hosting, responses, and QA policy input.

The role requires 8+ years in regulated environments, strong GCP knowledge, QMS mastery, CAPA tracking, and excellent client and internal collaboration.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• 8+ years in a regulated environment with GxP experience.
• Fluent in English, written and verbal.

Responsabilités

• Lead risk-based, end-to-end GCP audits (process, provider, site, study, for-cause).
• Provide regulatory guidance to internal stakeholders and clients.
• Coordinate sponsor qualification and routine audits and regulatory inspections.
• Act as primary QA contact throughout audit lifecycle and manage requests, access, and coordination.
• Review and challenge audit responses, CAPAs, and corrective actions.
• Track commitments, CAPAs and follow-up to closure, escalating overdue items.
• Maintain knowledge of QMS and drive progression of quality issues.
• Support QA relationships with strategic clients.
• Lead or support quality metrics, trend reporting, and global QA initiatives.
• Contribute to global QA policies and regulatory-compliant documentation.
• Deliver audit-related training and provide coaching to audit staff.
• Maintain ongoing professional knowledge through education and networks.

Connaissances

GCP auditing

Regulatory expertise

Quality management

CAPA processes

Client communication

Risk assessment

GxP experience

QA leadership

Formation

Bachelors in pharmacy/chemistry/biology

Description du poste

Fortrea is seeking a senior QA Compliance Lead Auditor for a US‑remote role with preference near Durham, NC. You will provide regulatory expertise, lead complex GCP audits, and support inspections, with accountability for audit hosting, responses, and QA policy input.

The role requires 8+ years in regulated environments, strong GCP knowledge, QMS mastery, CAPA tracking, and excellent client and internal collaboration.