The role focuses on ensuring participant safety, data integrity, and regulatory compliance across clinical trials in the APAC region including Japan
Job Summary
The role focuses on ensuring participant safety, data integrity, and regulatory compliance across clinical trials in the APAC region including Japan.
Candidates will lead GCP audits of medical institutions and suppliers while managing CAPA resolution and reporting to internal stakeholders.
The position requires strong bilingual communication skills in both Japanese and English to interact with investigators, internal teams, and global regulators.
Matching Summary
The role focuses on ensuring participant safety, data integrity, and regulatory compliance across clinical trials in the APAC region including Japan.
Skills & Requirements
Must-have
5+ years GCP auditing experience
Fluent Japanese communication skills
ICH-GCP and PMDA regulatory knowledge
On-site and remote audit execution
CAPA management and follow-up
Nice-to-have
Veeva Vault QMS system expertise
Risk-based audit planning capability
Global team collaboration experience
Data analysis and trend identification
Process improvement initiative leadership
Key Requirements
BS/BA degree or equivalent
Minimum 5 years practical GCP auditing experience
Fluent Japanese language proficiency
English business communication skills
Knowledge of ICH-GCP, PMD Law, FDA, and EMA regulations