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 through independent clinical quality assurance processes across the APAC region

Job Summary

  • The role focuses on ensuring participant safety, data integrity, and regulatory compliance through independent clinical quality assurance processes across the APAC region.
  • Candidates will lead GCP audits of medical institutions, manage vendor collaborations, and drive corrective and preventive actions (CAPA) to resolve quality observations.
  • The position requires fluency in both Japanese and English to effectively communicate with external stakeholders, internal teams, and regulatory authorities like the PMDA.

Matching Summary

The role focuses on ensuring participant safety, data integrity, and regulatory compliance through independent clinical quality assurance processes across the APAC region.

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 ability
  • Data analysis and trend identification
  • Process improvement initiative participation
  • Strong leadership and influence skills

Key Requirements

  • BS/BA degree or equivalent qualification
  • Minimum 5 years practical GCP auditing experience
  • Fluent Japanese language proficiency required
  • Ability to conduct audits in English
  • Knowledge of FDA and EMA regulations

Work Rights

Not specified

Tailored Resume

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