Director of Quality Assurance

Job Summary

Leading U.S. quality operations, the full-time salaried Director of Quality Assurance will manage compliance with regulatory requirements, oversee audits and inspections, and drive continuous improvement initiatives in a remote environment.

Key Responsibilities

• Lead U.S. Quality Assurance operations within the global Quality Management System (QMS) to ensure compliance
• Maintain inspection readiness and oversee audits, including FDA inspections and CAPA management
• Provide QA guidance to cross-functional teams to support compliant execution of programs and monitor quality metrics

Required Qualifications

• 10+ years of experience in clinical research, pharma, biotech, or CRO environments
• 8+ years in QA / Quality Management leadership roles
• Strong knowledge of GxP, FDA expectations, and clinical quality systems
• Experience operating in global or matrixed organizations
• Proven success leading audits, inspections, and CAPA programs