Pharmaceutical Quality GCP Auditors (Consulting)

Advarra, Inc.; Deutschland; Remote; USD 94.377 - 173.025; Teilzeit

Zusammenfassung

Advarra, Inc. is seeking Pharmaceutical Quality GCP Auditors to join our consultant network for German-based projects. Auditors support compliance reviews across GCP clinical sites and vendors.

Role involves planning audits, evaluating sites and vendors, and preparing audit reports detailing findings and root causes. Remote role open to candidates based in Germany with strong English and German communication skills.

Qualifikationen

• Minimum 10+ years of Clinical Quality Assurance and/or GCP experience.
• Minimum 5+ years of Good Clinical Practices auditing experience.
• Demonstrated experience with FDA/EMA expectations and audit readiness.
• Experience developing QA plans, audit programs, and corrective actions.
• Proficient in English and German at B2 level (written and spoken).

Aufgaben

• Conduct GCP audits (planning, agenda, on-site or remote) and report writing.
• Evaluate investigator sites, CROs, and vendors for compliance.
• Prepare comprehensive audit reports with findings and root causes.
• Provide corrective action support and present findings to QA leadership.
• Collaborate with clients to ensure adherence to quality standards.

Kenntnisse

GCP auditing

Clinical QA

Regulatory knowledge

Audit planning

English (B2)

German (B2)

Jobbeschreibung

Pharmaceutical Quality GCP Auditors (Consulting)

Job Category: Expert

Requisition Number: PHARM004113

• Posted: July 8, 2026
• Part-Time
• Remote

Locations

Remote - Germany

This role is open to candidates based in Germany.

Job Overview Summary

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.
• 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

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.