Senior Director, Site Quality Head- Newark, DE
About The Position
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. 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 site—but the global future of IVD manufacturing—this 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 Role As 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.
Requirements
- Senior 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.
Nice To Haves
- Professional certifications such as Certified Quality Manager or Six Sigma Black Belt are a plus.
Responsibilities
- Set 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.
Benefits
- medical insurance
- dental insurance
- vision insurance
- 401(k) retirement plan
- life insurance
- long-term and short-term disability insurance
- paid parking/public transportation
- paid time off
- paid sick and safe time
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What This Job Offers
Job Type
Full-time
Career Level
Senior
