Senior Director, Clinical Quality Assurance

About the Role:

The Senior Director, Clinical Quality Assurance, is a senior leadership position responsible for building, leading, and overseeing a global Good Clinical Practice quality program across clinical development activities. This role ensures that Phase I through Phase III clinical trials are conducted in compliance with regulatory standards, internal quality systems, and industry best practices. Common search terms include Senior Director Clinical Quality Assurance, GCP Quality Director, Clinical QA Leader, Head of Clinical Quality, and GxP Quality Assurance Director.

Responsibilities:

• Lead and execute global Clinical Quality Assurance strategy, aligning with regulatory requirements and organizational goals
• Establish, maintain, and continuously improve a GCP-compliant Quality Management System for clinical trials
• Provide quality oversight for global clinical trials, including late-stage Phase III studies, ensuring inspection readiness at all times
• Conduct risk-based quality assessments, identify compliance risks, and implement mitigation strategies across clinical programs
• Oversee vendor qualification, selection, and ongoing CRO and clinical site quality management
• Lead and manage GCP audits, including investigator sites, vendors, CROs, Trial Master Files, and Clinical Study Reports
• Serve as lead representative during regulatory inspections, including FDA and global health authorities, and manage responses to findings and CAPAs
• Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, and Biostatistics to ensure quality and compliance
• Develop, review, and update SOPs, quality processes, and compliance documentation to support continuous improvement
• Implement quality metrics, dashboards, and reporting systems to monitor compliance and drive operational excellence
• Investigate quality events, deviations, and nonconformances, ensuring root cause analysis and effective CAPA implementation
• Lead and mentor Clinical Quality Assurance staff and external resources, fostering a culture of quality and accountability

Qualifications:

• Bachelor's degree in life sciences, healthcare, or related field required, advanced degree preferred
• 15 or more years of experience in clinical quality, clinical development, or clinical operations within the biopharmaceutical industry
• 10 or more years of experience in GCP, GCLP, and global clinical quality assurance, including leadership experience
• Extensive experience supporting global clinical trials, including Phase III pivotal studies
• Strong expertise in GxP regulations, ICH guidelines, and global regulatory requirements for clinical trials
• Proven experience leading regulatory inspections and managing audit responses, CAPA development, and compliance remediation
• Demonstrated experience with vendor oversight, CRO management, and global clinical quality systems
• Strong leadership, project management, and stakeholder management skills in complex, fast-paced environments
• Excellent written and verbal communication skills, including technical documentation and audit reporting
• Proficiency with clinical systems such as eTMF, CTMS, and Quality Management Systems

Desired Qualifications:

• Professional certifications such as ASQ Certified Quality Auditor or Clinical Research Professional
• Experience supporting global regulatory inspections across multiple regions including FDA, EMA, and other agencies
• Experience building or scaling Clinical Quality Assurance functions in growing organizations
• Advanced knowledge of risk-based quality management and inspection readiness frameworks
• Experience developing and delivering GCP training programs and quality culture initiatives