R&d Clinical Quality Assurance Senior Specialist

Merck Sharp & Dohme Corp

Tokyo, Japan
**
5+ years gcp auditing experience
Ich-gcp and pmda regulatory knowledge
Fluent japanese communication skills
** Merck Sharp & Dohme Corp is seeking a Senior Specialist in R&D Clinical Quality Assurance to ensure compliance with global regulatory requirements and maintain high standards in clinical trials across the APAC region, including Japan. The ideal candidate will have extensive experience in GCP audits and proficiency in both Japanese and English. **

Job Summary

  • The role focuses on ensuring participant safety, data integrity, and regulatory compliance across clinical trials in the APAC region.
  • Candidates will lead GCP audits of medical institutions, manage CAPA follow-ups, and support PMDA inspection readiness.
  • The position requires strong bilingual communication skills to interact with internal teams and external stakeholders in both Japanese and English.

Matching Summary

Match Score: 75

** Merck Sharp & Dohme Corp is seeking a Senior Specialist in R&D Clinical Quality Assurance to ensure compliance with global regulatory requirements and maintain high standards in clinical trials across the APAC region, including Japan. The ideal candidate will have extensive experience in GCP audits and proficiency in both Japanese and English. **

Skills & Requirements

Must-have

  • 5+ years GCP auditing experience
  • ICH-GCP and PMDA regulatory knowledge
  • Fluent Japanese communication skills
  • English audit report writing capability
  • Risk-based audit planning expertise

Nice-to-have

  • Veeva Vault QMS system proficiency
  • Global team collaboration experience
  • Process improvement initiative leadership
  • Data analysis and trend identification
  • Cross-functional stakeholder management

Key Requirements

  • BS/BA degree or equivalent experience
  • Minimum 5 years practical GCP auditing experience
  • Knowledge of ICH-GCP, PMD Law, FDA, and EMA regulations
  • Fluency in spoken and written Japanese
  • Ability to conduct remote and on-site audits

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter