GCP Auditor Consultant (Freelance)

Job Summary
The GCP Auditor Consultant is an independent clinical quality professional responsible for conducting objective, risk-based audits of clinical trials, vendors, and quality systems to ensure compliance with ICH-GCP, global regulatory requirements, and client SOPs.

This is a high-impact consulting role suited for a seasoned professional with deep GCP expertise, strong regulatory inspection experience, and the ability to deliver actionable quality insights and support client needs across a range of clinical quality activities.

Qualifications

• · Bachelor’s degree at a minimum in a scientific, technical, healthcare or related discipline (advanced degree preferred)
• · Minimum 10+ years of experience in GxP-regulated environments
• · At least 8 years of experience in GCP auditing or clinical quality assurance
• · Proven experience conducting independent GCP audits
• · Strong knowledge of ICH-GCP guidelines
• · Strong knowledge of FDA regulations (21 CFR), EMA, and global regulatory frameworks
• · Experience supporting or hosting regulatory inspections
• · Experience auditing veterinary clinical studies and supporting animal health submissions preferred
• · Working knowledge of additional GxP areas including GLP, PV, GMP, GCLP, or CSV preferred
• · Demonstrated ability to operate independently as a senior auditor in complex environments
• · Proven ability to provide risk-based quality assessments and actionable recommendations
• · Strong communication, technical writing, and presentation skills
• Perform thorough audits of clinical trial sites, manufacturing processes, and quality systems to verify compliance with GCP guidelines and applicable regulations.
• Review documentation related to chemistry, manufacturing, and controls (CMC) to ensure accuracy and regulatory adherence.
• Assess adherence to FDA regulations and other relevant international standards during audits.
• Identify areas of non-compliance or potential risk, providing clear recommendations for corrective actions.
• Collaborate with project teams to develop audit plans, scope, and schedules tailored to client needs.
• Document audit findings meticulously, prepare detailed reports, and communicate results effectively to stakeholders.
• Support clients in implementing compliance management strategies and continuous improvement initiatives.

Responsibilities

• Conduct independent GCP audits of investigator sites, CROs, vendors, clinical systems, and EDC systems including qualification, surveillance, and performance monitoring audits
• Assess compliance with ICH-GCP guidelines, global regulatory requirements, and client SOPs
• Perform document review and quality evaluation of clinical data, reports, and quality systems
• Prepare clear, comprehensive audit reports with risk-based findings and recommendations
• Communicate audit outcomes to sponsors, stakeholders, and leadership teams
• Maintain complete, accurate, and inspection-ready audit documentation
• Support inspection readiness activities from an audit and gap assessment perspective
• Participate in mock inspections and provide expert input on potential compliance risks
• Provide strategic guidance on remediation approaches when contracted
• Offer advisory support for quality system improvements, vendor oversight, and inspection readiness as needed
• Deliver GCP and compliance-related training or presentations upon request
• Interface with cross-functional teams and external partners within the defined audit scope
• Maintain independence and objectivity as a third-party auditor
• Travel as required to conduct on-site audits

Pay: From $100.00 per hour

Work Location: Remote