Pharmaceutical Quality GCP Auditor – Consulting

Advarra

Advarra seeks Good Clinical Practice Auditors in Germany for compliance reviews at clinical sites and vendors. Role involves audit planning, conducting GCP audits, and report writing.

Posted 7/9/2026part-timeRemote • 🇩🇪 GermanySeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in conducting Good Clinical Practice (GCP) audits and developing quality assurance plans, with a strong focus on regulatory compliance and effective communication in English and German.

Highest-signal resume keywords

Good Clinical Practice (GCP) AuditingClinical Quality AssuranceRegulatory Compliance (FDA, EMA)Audit Report WritingCorrective Action Plans

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCP AuditsAudit Program DevelopmentQuality Assurance PlansRegulatory Agency ExpectationsRoot-Cause AnalysisAudit Readiness ActivitiesCorrective Actions SupportComprehensive Audit ReportingInvestigator Site EvaluationVendor Compliance Evaluation

Soft Skills

CollaborationCommunicationPresentation Skills

Industry Keywords

Good Clinical Practice (GCP)Clinical TrialsCROsQuality StandardsStakeholder Engagement

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Benefits

Comp & perks

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