Clinical Quality Consultant

Clinical Quality Assurance (GCP) Consultant | Neurology Biotech

Eblex Group is supporting an emerging biotechnology company developing a neurology-focused product and is seeking an experienced

Clinical Quality Assurance (CQA) Consultant

to provide hands-on GCP oversight across active clinical programs.

This is a contract opportunity suited to an independent consultant with strong inspection readiness and audit experience in early-phase biotech environments.

The consultant will support quality oversight across Phase I/II neurology studies, working closely with Clinical Operations, Regulatory Affairs, Medical, and external vendors to ensure regulatory compliance and proactive risk management.

Scope of Work for Clinical Quality Assurance Consultant: • Plan and conduct investigator site and vendor GCP audits • Provide risk-based quality oversight across clinical programs • Lead CAPA investigations, root cause analysis, and effectiveness reviews • Support TMF quality review and remediation activities • Contribute to inspection readiness strategy for potential MHRA, EMA, or FDA inspections • Review and advise on clinical SOPs and quality systems • Provide quality input during study start-up and ongoing trial conduct • Monitor compliance trends and escalate systemic risks

Ideal Background for Clinical Quality Assurance Consultant: • 5+ years in Clinical Quality Assurance within biotech or pharmaceutical environments • Demonstrated experience auditing early-phase or neurology/CNS trials • Strong working knowledge of ICH-GCP and relevant EU/UK and/or FDA regulations • Experience preparing organisations for regulatory inspections • Comfortable operating independently in a consultancy capacity • Experience supporting small or scaling biotech organisations preferred

Engagement Details for Clinical Quality Assurance Consultant: • Contract engagement (LTD or Umbrella / EOR) • Remote with occasional travel for on-site audits as required • Flexible level of effort depending on audit schedule and program milestones • Competitive hourly or daily consulting rate

This is an opportunity to work closely with a growing neurology biotech where quality oversight will directly influence development timelines and regulatory readiness.

clinical | clinical quality assurance consultant | GCP | clinical quality | biotech | Neuro | Neurology | Audit | ICH-GCP | Pharmaceutical | early phase | phase I | phase II