Green Life Science
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.
Key Responsibilities
- 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
Why Consider This Role
- 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