Pharmaceutical Quality GCP Auditor – Consulting

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

📋 Description

• Perform Good Clinical Practice (GCP) audits, including planning, agenda setting, physical or remote audits, and report writing.

• Assess investigator sites, Contract Research Organizations (CROs), and vendor compliance or qualification.

• Compile detailed audit reports that outline findings and identify 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 experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness initiatives.

• Established experience in creating and executing quality assurance plans, audit programs, and corrective action plans.

• B2 level proficiency in English communication, both verbal and written.

• B2 level proficiency in German communication, both verbal and written.

• Bachelor's degree required.

🏝️ Benefits

• N/A