Director of Quality Assurance

Director of Quality Assurance & Compliance | Clinical Research (SMO)

We’re supporting a leading US-based Site Management Organisation (SMO) specialising in Phase I–IV clinical trials
, with a strong footprint across neuroscience and related therapeutic areas.

This is a senior, hands-on quality leadership role based at a flagship Miami site, with broader exposure across a growing site network.

• Lead Quality Assurance & Compliance activities for a high-volume clinical research site
• Ensure compliance with ICH-GCP, FDA regulations, and study protocols
• Oversee internal audits, sponsor audits, and regulatory inspections
• Own CAPA management
  , deviation handling, and continuous improvement initiatives
• Partner closely with Site Leadership, Clinical Operations, and Medical leadership
• Manage and develop QA/QC staff
• Contribute to and support the wider corporate Quality Management System (QMS) across multiple sites
• Support inspection readiness and quality initiatives across the broader site network as needed
• Significant experience in clinical research quality within an SMO
  , CRO, or research site environment
• Strong hands-on knowledge of GCP, FDA regulations, and audit processes
• Proven experience leading or mentoring teams in a regulated environment
• Background supporting high-volume, patient-facing clinical trial operations
• Comfortable working on-site and partnering with operational leadership
• Willingness to travel occasionally to support other sites

• Leadership role within a fast-growing, established clinical research organisation
• High-impact position with visibility across site and corporate quality functions
• Opportunity to shape quality culture and inspection readiness at scale