Pharmaceutical Quality GCP Auditor – Consulting

This is a fully remote position, open to applicants in Japan.

📋 Description

• Perform Good Clinical Practice (GCP) audits, including planning, creating agendas, conducting physical or remote audits, and writing reports.

• Assess compliance or qualification of investigator sites, CROs, and vendors.

• Compile detailed audit reports that outline findings and root causes.

• Deliver written audit reports in English.

• If necessary, offer support for corrective actions and present findings to QA leadership and stakeholders.

• Collaborate effectively with clients to uphold quality standards.

⛳️ Requirements

• At least 10+ years of experience in Clinical Quality Assurance and/or Good Clinical Practice (GCP).

• A minimum of 5+ years of experience in auditing Good Clinical Practices.

• Proven knowledge of regulatory agency expectations (such as FDA, EMA) and activities related to audit readiness.

• Demonstrated ability to develop and implement quality assurance plans, audit programs, and corrective action plans.

• Proficiency in English communication at a B2 level, both verbal and written.

• Proficiency in Japanese communication at a B2 level, both verbal and written.

• Bachelor's degree required.

🏝️ Benefits

• Flexible work arrangements.

• Opportunities for professional development.