Senior GCP QA Compliance Lead Auditor (Remote)

Fortrea; Durham (NC); Remote; USD 70,000 - 125,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k)

Job summary

Fortrea is seeking a QA Compliance Lead Auditor, a senior role in its Global Quality Assurance organization. This US‑remote position prefers candidates near Durham, NC and focuses on regulatory expertise, leading GCP audits, and inspection readiness.

The role acts as SME supporting internal teams, clients, and regulatory authorities, driving quality initiatives and ensuring timely responses, CAPAs, and robust audit hosting across the globe.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum 8 years of experience in a regulated environment, including GxP roles.
• Regulatory expertise with knowledge of GCP and global regulations.
• Experience as Lead GCP Auditor with risk-based assessment skills.
• Strong communication with clients and internal stakeholders.

Responsibilities

• Conduct risk-based, end-to-end GCP audits including clinical sites and sponsors.
• Provide regulatory guidance to internal teams, clients, and authorities.
• Coordinate hosting of audits, inspections, and related activities.
• Serve as primary QA contact through audit lifecycle, manage requests and documentation.
• Review audit responses and CAPAs to ensure timely closure.
• Track commitments, CAPAs, and evidence, escalating overdue items.
• Maintain QMS knowledge and progress quality issues and CAPAs.
• Deliver audit-related training and mentor other staff.
• Stay updated on regulatory guidance and industry publications.
• Support QA-to-QA relationships with strategic clients.

Skills

GCP audits

Regulatory compliance

Quality metrics

Stakeholder communication

Auditing leadership

Education

Bachelor's degree in Pharmacy, Chemistry, Biology

Job description

Fortrea is seeking a QA Compliance Lead Auditor, a senior role in its Global Quality Assurance organization. This US‑remote position prefers candidates near Durham, NC and focuses on regulatory expertise, leading GCP audits, and inspection readiness.

The role acts as SME supporting internal teams, clients, and regulatory authorities, driving quality initiatives and ensuring timely responses, CAPAs, and robust audit hosting across the globe.