Sr Director Clinical Quality Assurance

Overview

• Lead the global Clinical Quality Assurance strategy, ensuring compliance with regulations and guidelines.
• Drive digital transformation to enhance quality oversight capabilities and knowledge within the organization.
• Collaborate with cross-functional teams to align clinical portfolio and business strategies.
• Manage relationships with regulatory bodies to address emerging needs and issues.
• Oversee operational and budget management, vendor relations, and resource planning.
• Lead initiatives for continuous improvement and advanced analytics adoption.
• Provide strategic oversight and stakeholder management across levels internally and externally.
• Manage and develop a team of Clinical Quality Assurance professionals.

Key Responsibilities & Duties

• Design and execute the global Clinical Quality Assurance strategy, including audit and inspection management.
• Conduct complex audits of sites, vendors, and internal processes.
• Train junior auditors and contribute to training audits.
• Trend and leverage internal audit and industry intelligence to improve quality systems.
• Direct future-focused skill development initiatives through partnerships and technology adoption.
• Build relationships with industry QA communities and present at conferences.
• Manage talent within the team, including performance management and development.
• Travel up to 20% for audits, inspections, and stakeholder engagements.

Job Requirements

• Bachelor's or Master's degree with 15+ years of clinical pharmaceutical experience.
• Substantial experience in Clinical Quality Assurance conducting diverse audits.
• Knowledge of GxP systems, CSV regulations, and quality processes.
• Proven strategic and operational management experience in clinical quality projects.
• Leadership experience managing teams and influencing senior stakeholders.
• Strong performance in strategic oversight and stakeholder management.
• Ability to travel up to 20% for professional engagements.
• Preferred certifications in quality assurance or clinical compliance.