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Associate Director – Quality Standards and Continuous Improvement
RegeneronAssociate Director ensuring quality standards and continuous improvement in a biotechnology company. Overseeing Issue Management framework and collaborating with cross-functional teams.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Benefits
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Issue ManagementQuality Event strategiesRoot cause analysisCAPAsQuality Management System oversightQuality governanceContinuous improvementRegulatory agency inspectionsGood Clinical PracticeGood Pharmacovigilance Practice
Soft Skills
LeadershipCoachingMentoringCross-functional alignmentCommunicationStandard settingKnowledge sharingTeam developmentPerformance monitoringTrend analysis