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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