Associate Director - Quality Standards and Continuous Improvement

Job Description

Responsibilities

• Oversee the end-to-end Issue Management framework, ensuring standardized, compliant, and inspection-ready practices
• Define and evolve Issue Management and Quality Event strategies to support scalability, efficiency, and consistency
• Drive cross-functional alignment across Quality Event Leads (QEL) and functional teams to ensure consistent and right sized approach to issue management and quality decision-making
• Lead QEL forums and provide SME guidance on QMS governance, continuous improvement, and inspection readiness
• Ensure consistency in investigations, root cause analysis, CAPAs and documentation standards
• Lead and develop line reports whilst also supporting the broader QEL community through coaching, standard setting, and knowledge sharing
• Monitor Issue Management performance through metrics and trend analysis

Requirements

• Bachelor's degree with at least 10 years of relevant healthcare or pharmaceutical industry experience
• Experience in quality, compliance, quality management, quality assurance or clinical development
• Expertise or transferable skills related to Good Clinical Practice or Good Pharmacovigilance Practice
• Experience training, supervising, mentoring, developing staff and leading a small team
• Advanced knowledge of quality management system oversight, quality governance and continuous improvement
• Experience participating in, managing and leading regulatory agency inspections