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Consultant: Clinical QA (GCP)

Denmark · Job Posted February 17, 2026
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Job Description

The consultant will assess the current “as-is” clinical QA/GCP and clinical safety oversight setup, identify gaps versus expectations, and implement remediation through pragmatic processes, governance, and SOP libraries. The goal is to elevate compliance maturity and ensure robust oversight of clinical activities and vendors, while strengthening readiness for audits and regulatory inspections.

Job Responsibility

  • Quality oversight (GCP) across clinical delivery
  • Clinical Safety / PV quality interface
  • Gap assessment (“as-is”) and remediation plan
  • Build/upgrade SOP library and process framework
  • Audits, inspections, and readiness activities

Requirements

  • Many years of experience in Clinical QA (senior-level capability
  • strong independence)
  • Specific QA GCP experience with demonstrated oversight responsibilities (not only operational execution)
  • Strong track record with audits and regulatory inspections (preparation and/or hosting/support)
  • Experience in rare disease programs and/or complex clinical settings
  • Experience in small biotech/lean organizations where the consultant can build structure without heavy bureaucracy
  • Ability to operate hands-on: building SOPs, setting up governance, and driving adoption

Nice to have

  • Prior experience working closely with Clinical Safety/PV teams and vendors, including oversight and quality interface design
  • Broader GxP quality exposure (e.g., QMS build, quality risk management) if relevant to clinical scope

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