Freelance Life Sciences Auditor (Japan)

TL;DR

Freelance Life Sciences Auditor (Japan): Conducting specialized audits across clinical research, pharmacovigilance, and manufacturing environments with an accent on Japanese regulatory compliance (GCP, GVP, GPSP, GMP). Focus on planning, executing, and reporting audit findings while managing CAPA processes and maintaining professional objectivity for diverse client projects.

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 compliance risks and prepare clear, structured audit reports.
• Support follow-up activities, including root cause analysis and CAPA response reviews.
• Engage professionally with clients and auditees during onsite or remote audit activities.

Requirements

• Must be based in Japan and able to support onsite audit work.
• Native level Japanese language capability required.
• Business level English for documentation and client communication.
• Proven audit experience in life sciences (pharmaceutical, biotech, CRO, or related).
• Strong working knowledge of Japanese regulations (GCP, GVP, GPSP, or GMP).
• Ability to work independently on project-based contractor assignments.

Nice to have

• Experience as an independent consultant or freelance auditor.
• Experience supporting international clients or global quality teams.
• Experience conducting audits in both Japanese and English environments.
• Experience with inspection readiness and mock inspections.

Culture & Benefits

• Flexible, project-based freelance engagement.
• Opportunity to work with diverse, high-profile drug and device programs.
• Commitment to diversity, equity, and inclusion.
• Professional environment with a focus on collaborative and entrepreneurial spirit.