R&d Clinical Quality Assurance Senior Specialist

Merck & Co., Inc.

Japan
Hybrid
5+ years gcp auditing experience
Fluent japanese communication skills
Ich-gcp and pmda regulation knowledge
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, manage CAPA processes, and utilize Veeva Vault QMS to drive quality standards within the organization.
  • Success requires fluent Japanese and English communication skills to effectively interact with investigators, internal teams, and global stakeholders.

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 regulation knowledge
  • On-site and remote audit execution
  • CAPA proposal and follow-up expertise
  • Veeva Vault QMS system implementation

Nice-to-have

  • Global team collaboration experience
  • Risk-based audit planning capability
  • Data analysis and trend identification
  • Process improvement initiative leadership
  • Cross-functional stakeholder engagement

Key Requirements

  • BS/BA degree or equivalent qualification
  • Minimum 5 years practical GCP auditing experience
  • Knowledge of ICH-GCP, PMD Law, FDA, and EMA regulations
  • Proven ability to conduct on-site and remote audits
  • Strong understanding of clinical trial lifecycle and protocols

Work Rights

Not specified

Tailored Resume

Cover Letter