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
#J-18808-Ljbffr
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
#J-18808-Ljbffr