Director of Clinical Quality

📋 Description

• Own and lead the quality function across GCP QA and Business Quality.
• Lead GCP audits, inspection readiness, and regulatory quality matters.
• Oversee IMS with ISO 9001 and ISO 27001; improve processes.
• Develop SOPs, CAPA, deviation, risk management for trials.
• Guide clinical ops with regulatory updates (US FDA, EU/UK).
• Lead a small team; partner with US/UK clinical operations leadership.

🎯 Requirements

• 10+ years in GCP QA leadership roles (planning/conducting audits).
• 10+ years with ICH GCP (E6 R2/R3) and FDA regs; EU/UK exposure.
• Experience prepping regulatory inspections (FDA/EMA) and sponsor audits.
• Experience building a GCP QA system: SOPs, CAPA, deviations, risk.
• Able to advise ops teams on evolving regulations.
• Experience with eQMS (Qualio) and practical quality systems.
• Strong team leadership: manage and develop small teams, hands-on.
• High initiative and bias for action; passionate about transforming healthcare.

🎁 Benefits

• Competitive salary plus equity.
• Annual $2,000 Learning & Development budget.
• 39 days annual leave (PTO + holidays).
• Health: $800 monthly insurance contribution.
• Wellbeing: $40 monthly wellness allowance.
• Gym and Happl discounts.