Director of Quality and Compliance

Director of Quality Assurance & Compliance (Clinical Research)

We are seeking a seasoned quality professional to lead and advance clinical research quality initiatives within a high-performing multi-site research environment.

• Provide strategic and operational leadership for quality assurance and compliance across clinical research sites.
• Ensure day-to-day trial operations adhere to regulatory requirements, industry standards, study protocols, and internal procedures.
• Lead and coordinate internal, external, and regulatory audits, maintaining inspection readiness and managing follow-up actions.
• Oversee corrective and preventive action (CAPA) management, quality events, document control, training compliance, and electronic quality systems.
• Collaborate with site leadership, investigators, and operations teams to maintain consistent quality and compliance across studies.
• Mentor and manage QA/QC staff, fostering a proactive and inspection-ready quality culture.
• Support organization-wide quality initiatives, including cross-site audits and continuous improvement efforts.
• Act as a primary quality liaison in interactions with clients, sponsors, and stakeholders, ensuring clear communication and alignment.

• Extensive experience in clinical research quality within multi-site or networked research organizations.
• Strong knowledge of FDA regulations, ICH/GCP guidelines, and clinical trial operations.
• Demonstrated leadership experience in audit management, inspections, and CAPA oversight.