Freelance GCP Auditor

Job Summary

To support pharmaceutical and biotechnology clients, the part-time Freelance GCP Auditor will plan and conduct independent, risk-based GCP audits across Japan, utilizing both remote and on-site work arrangements as needed.

Key responsibilities

• Plan and conduct independent GCP audits against applicable Japanese GCP requirements and ICH GCP principles
• Review pre-audit records and prepare audit plans, including interviewing site or vendor personnel and assessing clinical trial processes
• Record observations, assess their significance, and prepare timely audit reports while maintaining confidentiality and objectivity

Required qualifications

• Direct experience conducting or co-conducting GCP audits in clinical research or related settings
• Demonstrated capability in at least one GCP audit specialism, including audit evidence assessment and report preparation
• Working knowledge of Japanese GCP and PMDA/MHLW expectations, with familiarity with ICH GCP
• Native-level Japanese proficiency for detailed interviews and document reviews
• Professional English sufficient for international coordination and audit reporting