Auditor (Life Sciences)

TL;DR

Auditor (Life Sciences): Conducting specialized audits across clinical research, pharmacovigilance, and manufacturing environments with an accent on Japanese regulatory compliance (GCP, GVP, GPSP, GMP). Focus on identifying compliance risks, preparing detailed audit reports, and supporting CAPA follow-up activities for biotech and pharmaceutical clients.

Location: Must be based in Japan and able to support onsite audit work when required.

Company

hirify.global provides expert consulting and operational support to biotech, med device, and pharmaceutical organizations across the complete product lifecycle.

What you will do

• Plan, conduct, and report audits in alignment with Japanese regulations and client requirements.
• Perform audits across clinical research, pharmacovigilance, PMS, GVP, GPSP, and GMP environments.
• Review operational processes, quality systems, and vendor oversight controls.
• Identify audit findings, assess compliance risks, and prepare structured audit reports.
• Support follow-up activities including root cause analysis and CAPA review.
• Engage professionally with clients and auditees during onsite or remote audit assignments.

Requirements

• Must be based in Japan and available for onsite audit work.
• Native level Japanese language proficiency required.
• Business level English for documentation and client communication.
• Proven experience conducting audits in life sciences environments (GCP, GVP, GPSP, or GMP).
• Strong working knowledge of applicable Japanese regulations.
• Ability to work independently as a freelance contractor.

Culture & Benefits

• Freelance contractor engagement model offering flexibility.
• Opportunity to work on diverse, high-profile audit projects.
• Collaborative environment committed to diversity, equity, and inclusion.
• Professional development through exposure to global quality teams.