Senior Director, Site Quality Head- Newark, DE

Own the Quality Vision. Shape a Global Impact. Lead What's Next in Diagnostics.If you're a transformative quality leader ready to influence not just one sitebut the global future of IVD manufacturingthis is your moment. Step into a role where your decisions elevate patient safety, strengthen global standards, and drive innovation across an international reagent manufacturing network.The RoleAs the Senior Director, Site Quality Head, you'll define and execute the site's quality strategy, develop top-tier talent, and ensure world-class regulatory excellence. You will be the catalyst for digital transformation, continuous improvement, and harmonized quality practices across our global network.What You'll DoSet the quality vision and align the site to global standards and enterprise strategy.Lead, coach, and grow a skilled team of managers, engineers, and QC leaders.Drive regulatory excellence and ensure readiness for audits, inspections, and IVD compliance.Modernize quality systems, champion digitalization, and accelerate continuous improvement.Collaborate globally to harmonize processes and elevate quality maturity across sites.Partner cross-functionally to embed quality thinking into operations and strategic planning.What You BringSenior leadership experience in quality or manufacturing within IVD, medical devices, pharma, or similar regulated industries.Bachelor's degree in Engineering or Life Sciences.Strong knowledge of ISO 13485, IVDR, 21 CFR 820, and diagnostic manufacturing expectations.Proven ability to inspire teams, build capability, and develop future leaders.A data-driven approach with experience using digital tools or analytics to improve quality performance.Professional certifications such as Certified Quality Manager or Six Sigma Black Belt are a plus.Lead with Purpose. Deliver Global Impact.Join us and help drive breakthroughs in healthcareeverywhere, for everyone. Become the leader who shapes the next era of reagent manufacturing quality.