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Advarra

GCP Auditor, Poland

Advarra

. Conduct Good Clinical Practice (GCP) audits, including planning, agenda preparation, physical or remote audits, and report writing .

Posted 11/6/2026full-timeRemote • PolandSeniorLeadWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Expertise in Good Clinical Practice (GCP) auditing and Clinical Quality Assurance, with a strong focus on compliance, regulatory agency expectations, and quality assurance plan development. Proficient in report writing and effective communication in both Polish and English.

Highest-signal resume keywords
Good Clinical Practice (GCP) AuditingClinical Quality AssuranceRegulatory Agency Compliance (FDA, EMA)Audit Readiness ActivitiesQuality Assurance Plan Development

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
GCP AuditsAudit Report WritingCompliance EvaluationCorrective Action PlansQuality Assurance PlansAnalytical SkillsProblem-Solving Skills
Soft Skills
Interpersonal SkillsClient Interaction SkillsCollaboration SkillsCommunication Skills
Industry Keywords
Clinical TrialsCROsAudit ProgramsStakeholder EngagementAdvarra Consultant Network

About the role

Key responsibilities & impact
  • Conduct Good Clinical Practice (GCP) audits, including planning, agenda preparation, physical or remote audits, and report writing
  • Evaluate investigator sites, CROs, and vendors for compliance or qualification
  • Prepare comprehensive audit reports detailing findings and root causes
  • Provide written audit reports in English
  • Support corrective actions and present findings to QA leadership and stakeholders when required
  • Work collaboratively with clients to ensure quality standards
  • Join Advarra's consultant network for Poland-based projects

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, including FDA and EMA
  • Demonstrated experience in audit readiness activities
  • Demonstrated experience developing and implementing quality assurance plans, audit programs, and corrective action plans
  • B2 level Polish communication, verbal and written
  • B2 level English communication, verbal and written
  • Bachelor's degree
  • 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
  • Registration in Advarra's Expert Enrollment Form is required for candidates not already in the Network

Benefits

Comp & perks
  • Inclusive and collaborative work environment
  • Respect for diverse perspectives
  • Empathy and care for clients and clinical trial participants
  • Consultant network opportunities
  • Corrective actions support and presentation opportunities, if required