Consultant: Clinical QA (GCP)
Black Swans Exist is looking for an experienced consultant on behalf of a client to strengthen Clinical Quality Assurance with a strong GCP oversight foundation and solid understanding of Clinical Safety / Pharmacovigilance (PV) interfaces. The assignment is focused on gap assessment, remediation, and building fit-for-purpose processes and SOP libraries—with an emphasis on audit/inspection readiness.
Assignment summary
- Discipline: Clinical QA (GCP) with Clinical Safety/PV oversight interface
- Industry context: Biotech / smaller company environment (preferred)
- Therapeutic area: Rare disease
- Start: ASAP
- Workload: Part-time (indicatively 2 days/week)
- Location: Open / flexible — Denmark, UK, and broader EU considered (remote-first possible depending on profile and client needs)
Mission
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.
Key responsibilities
1) Quality oversight (GCP) across clinical delivery
- Establish and execute risk-based GCP oversight of clinical activities (internal and vendor/CRO-led).
- Ensure quality governance for key clinical processes (e.g., TMF oversight, vendor oversight, issue management, deviations/CAPA, training, change control where applicable).
- Support quality decision-making with clear documentation and defensible rationale.
2) Clinical Safety / PV quality interface
- Strengthen the QA interface into Clinical Safety/PV, especially where it intersects with clinical operations.
- Review and improve oversight of safety processes relevant to clinical programs (e.g., safety case handling interfaces, reconciliation touchpoints, oversight of PV vendors/partners as applicable).
- Ensure inspection-ready documentation and traceability for safety oversight activities connected to clinical trials.
3) Gap assessment (“as-is”) and remediation plan
- Conduct a structured gap assessment of current QA/GCP and relevant PV oversight practices.
- Define a prioritized remediation roadmap with clear owners, timelines, and risk rationale.
- Provide pragmatic recommendations suited to a smaller organization and rare disease realities.
4) Build/upgrade SOP library and process framework
- Design, write, and/or refresh SOPs, work instructions, templates, and quality plans required to support compliant clinical execution.
- Ensure the SOP library is usable (not over-engineered) and supports consistent execution across stakeholders and vendors.
- Facilitate roll-out: training approach, adoption support, and alignment with stakeholders.
5) Audits, inspections, and readiness activities
- Plan and/or perform audits (vendor, system, process, trial-level) and support audit follow-up (CAPAs, effectiveness checks).
- Strengthen inspection readiness posture: mock inspection support, readiness reviews, storyboarding, and evidence mapping.
- Coach stakeholders on inspection communication and documentation expectations.
Deliverables (expected outputs)
By the end of the initial engagement (4–6 months), the consultant is expected to deliver:
- A documented gap assessment (as-is vs. expectations) and risk-based remediation plan
- A working process framework with prioritized SOP library (new and/or updated SOPs, templates, and guidance)
- Implemented GCP oversight model (governance cadence, vendor oversight approach, quality risk management touchpoints)
- Improved audit/inspection readiness, including evidence mapping and readiness actions
- Clear handover package enabling the client to sustain the model after the assignment
Ideal background
Must-haves
- 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).
Strong advantages
- 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-haves
- 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.
Please Reply via the Link or contact Søren via: E-mail:S.Bach@BlackSwansExist.com
