Director of Quality - Biologicals and Chemicals Division

Lead and execute the network-wide Manufacturing Quality strategy aligned with BCD Quality operating model across multiple manufacturing sites. Provide end-to-end Quality leadership ensuring compliance to ISO 13485, FDA 21 CFR 820, and MDSAP standards while driving harmonization of processes and metrics. Own product Quality performance, including primary KPIs related to complaints, cost of poor quality, and manufacturing health. Lead and develop a global team across Quality Engineering, QMS, laboratories, and product release functions, partnering with Operations, R&D, and Regulatory Affairs to ensure successful product lifecycle management. Drive proactive quality engineering strategies and continuous improvement initiatives such as Lean Six Sigma. Oversee complaint and nonconformance management across sites and serve as the escalation point for critical quality issues. Lead customer and regulatory interactions, including audits, inspections, and issue resolution, while enabling execution readiness for regional capacity expansion and new product introductions. Establish and maintain a strong culture of quality, accountability, and continuous improvement across the network.