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.

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
Bachelor's degree

Pharmaceutical Quality GCP Auditor – Consulting

Key skills