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

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

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave) for eligible employees at all levels

Associate Director – Quality Standards and Continuous Improvement

Key skills