Senior GCP QA Compliance Lead Auditor — Remote

Lifelancer Ltd; United States; Remote; USD 70,000 - 125,000; Full time

Job summary

Lifelancer Ltd in the United States is seeking a QA Compliance Lead Auditor (GCP) for a remote-based role, ideally near Durham, NC. You will join Fortrea’s Global Quality Assurance organization and lead complex GCP audits and regulatory inspections.

The role requires 8+ years in a regulated environment, deep regulatory expertise in GCP and global regulations, and strong skills in risk-based assessment, CAPA handling, and client communications.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology or 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 with GxP.

Responsibilities

• Conduct and lead risk-based, end-to-end GCP audits, including sponsor and site audits.
• Provide regulatory guidance to internal teams, clients, and regulatory authorities.
• Coordinate and host sponsor qualification and routine audits and inspections.
• Serve as primary QA point of contact throughout audit and inspection lifecycle.
• Facilitate and review audit responses, CAPAs, and corrective actions.
• Track commitments, CAPAs, evidence, and follow-up through closure.

Skills

GCP audits

Regulatory expertise

Risk-based assessment

CAPA management

Client communication

Education

Bachelor’s degree in Pharmacy, Chemistry, Biology

Master’s degree (MSc) preferred

Job description

Lifelancer Ltd in the United States is seeking a QA Compliance Lead Auditor (GCP) for a remote-based role, ideally near Durham, NC. You will join Fortrea’s Global Quality Assurance organization and lead complex GCP audits and regulatory inspections.

The role requires 8+ years in a regulated environment, deep regulatory expertise in GCP and global regulations, and strong skills in risk-based assessment, CAPA handling, and client communications.