Regeneron
Pharmaceutical
AssociateDirector-QualityStandardsandContinuousImprovement
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“Associate Director - Quality Standards and Continuous Improvement at Regeneron. Skills: Quality Standards, Continuous Improvement, Issue Management. Oversee Issue Management framework. Ensure standardized practices”
Industry & Context.
Root cause analysis
What They're Looking For.
Must Have
10 years relevant experience, Quality, compliance, quality assurance experience, Clinical development experience, Good Clinical Practice expertise, Good Pharmacovigilance Practice expertise, Training, supervising, mentoring staff, Developing staff experience, Leading a small team, Quality management system oversight knowledge, Quality governance knowledge, Continuous improvement knowledge, Participating in regulatory inspections, Managing regulatory agency inspections, Leading regulatory agency inspections
What You'll Do.
Oversee Issue Management framework
Ensure standardized practices
Ensure compliant practices
Ensure inspection-ready practices
Define Issue Management strategies
Evolve Issue Management strategies
Define Quality Event strategies
Evolve Quality Event strategies
Drive cross-functional alignment
Ensure consistent approach
Ensure right sized approach
Ensure consistency in investigations
Ensure consistency in root cause analysis
Ensure consistency in CAPAs
Ensure consistency in documentation standards
Support QEL community
Set standards for QEL community
Share knowledge with QEL community
Monitor Issue Management performance
Analyze Issue Management metrics
Analyze Issue Management trends
How You'll Work.
Team & Collaboration
Cross-functional teams; Internal leaders; Functional stakeholders
Full Job Description
**Build our future together** 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. ## When & where: * Location: Uxbridge, Dublin, Warren or Armonk * Hybrid model ## Discover your role: * 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. ## This role requires: * 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 Pract
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