Sr. Manager / Associate Director, Quality Events

The Sr. Manager / Associate Director of Quality Events provides strategic leadership and program governance over the company’s Nonconformance, CAPA, Planned Deviation, and Quality Investigation systems. This role ensures strict compliance with FDA and global regulatory requirements while driving organizational maturity from reactive compliance to proactive, data-driven prevention. The position involves presenting critical quality metrics to executive leadership and championing continuous process improvement across Clinical Laboratory Operations, Assay Development, and Manufacturing/Supply Chain.