OVERVIEW :

Our client  is in the early stages of building out their clinical quality infrastructure. Lean team  that is actively getting ahead of inspection readiness.

SCOPE & RESPONSIBILITIES :

• ICH R3 SOP alignment – review every SOP touching GCP processes, identify the gaps, and revise or write new procedures to meet R3 requirements. This is the primary deliverable. The person needs to be comfortable owning documents, not just reviewing them.
• RIF deviation review – there was a recent reduction in force. The task is to identify whether any GCP-touching areas generated deviations as a result and build out mitigation plans for anything that did.
• GCP inspection readiness – lead the initiative end to end. Work with clinical and study teams to build inspection storyboards, deliver training, and get the organization ready. BIMO inspection readiness experience is a major plus here.

SPECIAL REQUIREMENTS:

• 10+ years of GCP clinical quality experience.
• BIMO inspection readiness experience – the most important differentiator. Direct experience preparing teams and building storyboards for FDA BIMO inspections is what they are looking for.
• SOP writing and revision.

LOGISTICS:

• 30 per week, consistent throughout the engagement.
• Contract length: Rest of 2026.
• Target start: Early April 2026.
• Fully remote.