Our client is seeking a Director of Clinical Quality Assurance (CQA) to lead GCP quality and compliance across clinical development programs.
The Director will oversee the Clinical Quality function, working closely with Clinical Operations, Regulatory Affairs, and cross-functional teams to maintain FDA, ICH-GCP, and global regulatory standards.
Responsibilities
- Lead Clinical Quality Assurance (CQA) strategy and Quality Management System (QMS)
- Ensure compliance with FDA regulations (21 CFR 11, 50, 56, 312) and ICH-GCP
- Oversee internal, vendor, and clinical site audits
- Lead inspection readiness and regulatory inspection support (FDA and global agencies)
- Manage CAPA systems, deviations, and root cause investigations
- Develop and monitor quality metrics and risk-based quality processes
- Maintain and improve SOPs and quality documentation
- Partner with Clinical Ops, Regulatory, Data Management, and Medical teams
- Lead and develop QA team members
Requirements
- 8 to 12+ years in Clinical QA or clinical research in regulated environments
- 5+ years in a leadership role
- Solid knowledge of ICH-GCP and global regulatory requirements
- Experience with audits, CAPA, and inspection readiness
- Strong leadership and cross-functional communication skills
- Biotech, pharma, or CRO background
Preferred
- Advanced degree (MS, MPH, PharmD, MBA, or related)
- RAC or ASQ CQA certificationExperience with global clinical trials and eQMS systems