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.

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

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