Pharmaceutical Quality GCP Auditor – Consulting

Advarra

Good Clinical Practice Auditors supporting compliance reviews across GCP clinical sites in Japan. Conducting audits and ensuring quality standards for clinical research.

Posted 7/9/2026part-timeRemote • 🇯🇵 JapanSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Expertise in conducting Good Clinical Practice (GCP) audits and developing quality assurance plans, with a strong focus on regulatory compliance and effective communication in English and Japanese.

Highest-signal resume keywords

Good Clinical Practice (GCP) AuditingClinical Quality AssuranceRegulatory Compliance (FDA, EMA)Audit Report WritingQuality Assurance Plan Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCP AuditsAudit Program DevelopmentCorrective Action PlansRegulatory Agency ExpectationsAudit Readiness Activities

Soft Skills

Collaborative WorkEffective Communication

Industry Keywords

Clinical TrialsInvestigator SitesCROsVendor ComplianceQuality Standards

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and report writing)
Evaluate investigator sites, CROs, and vendor compliance or qualification.
Prepare comprehensive audit reports detailing findings and root-causes.
Provide written audit reports in English.
If required will provide corrective actions support and present findings to QA leadership and stakeholders
Work collaboratively with clients to ensure quality standards.

Requirements

What you’ll need

Minimum 10+ years of Clinical Quality Assurance and/or Good Clinical Practice (GCP) experience.
Minimum 5+ years of Good Clinical Practices auditing experience.
Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness activities.
Demonstrated experience in developing and implementing quality assurance plans, audit programs, and corrective action plans.
B2 level in English communication, verbal and written
B2 level in Japanese communication, verbal and written
Bachelor's degree

Benefits

Comp & perks

Flexible work arrangements
Professional development opportunities