FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
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.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
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
Industry Keywords
HealthcarePharmaceuticalQuality assuranceComplianceClinical developmentInspection readinessQMS governanceQuality Event LeadsIssue Management frameworkInspection-ready practices
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