Global GCP Auditor (Contract) - Travel Ready

RQM+; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

RQM+ is seeking a seasoned GCP Auditor to join our Global Audit Practice on a contract basis in the United States. You will plan, conduct, and report GCP audits to assess compliance with FDA, ICH GCP, and international regulations, working with clients, sites, sponsors, CROs, and vendors.

The ideal candidate has 10+ years in clinical research or QA, strong writing and communication skills, and the ability to travel domestically and internationally.

Qualifications

• 10+ years in clinical research, clinical operations, quality assurance, GCP auditing, or a related field.
• Significant hands-on experience conducting GCP audits across multiple clinical research environments.
• Bachelor's degree in life sciences or related discipline; equivalent experience considered.
• Expert-level knowledge of ICH GCP and applicable clinical research regulations and guidance.
• Strong technical writing and audit report-writing skills.
• Excellent verbal communication, presentation, and client-facing abilities.

Responsibilities

• Plan, conduct, and report GCP audits to assess compliance with regulations, guidelines, protocols, and organizational procedures.
• Identify compliance risks, strengthen quality systems, and maintain inspection readiness across the clinical development lifecycle.
• Audit clinical trial activities including sites, sponsors, CROs, vendors, systems, and processes; communicate findings and provide practical, risk-based recommendations.

Skills

GCP auditing

Regulatory compliance

Clinical research

FDA / NB inspections

21 CFR Part 11

Risk-based auditing

Quality systems

CAPA investigations

Clinical trials management

Travel readiness

Education

Bachelor's degree in life sciences

Job description

RQM+ is seeking a seasoned GCP Auditor to join our Global Audit Practice on a contract basis in the United States. You will plan, conduct, and report GCP audits to assess compliance with FDA, ICH GCP, and international regulations, working with clients, sites, sponsors, CROs, and vendors.

The ideal candidate has 10+ years in clinical research or QA, strong writing and communication skills, and the ability to travel domestically and internationally.