Das ist der Job
Location
This role is open to candidates based in Germany.
Darum lohnt es sich
Job Overview
Advarra is seeking Good Clinical Practice (GCP) Auditors to join our consultant network for German-based projects. Auditors support compliance reviews across GCP clinical sites and vendors.
Job Duties & Responsibilities
• 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.
Basic Qualifications
• 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 German communication, verbal and written
• Bachelor's degree
Preferred Qualifications
• Strong interpersonal and client interaction skills.
• Excellent analytical, problem-solving, communication, and report‑writing skills.
• Ability to work collaboratively across departments and interact with internal and external stakeholders.
