Associate Director - Quality Standards and Continuous Improvement

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, Quality Standards and Continuous Improvement to join our Global Development Quality team, supporting quality management system oversight, governance, quality events and continuous improvement across Global Development. In this role, you will help maintain effective quality standards and processes while collaborating with internal leaders, functional stakeholders and cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organisation making a meaningful difference to patients worldwide.,

• 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.
  
  Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter.