Director, Quality Assurance

The Director of Quality Assurance will lead the Quality Assurance Department, managing and improving programs like product release, document management, specifications, change control, supplier qualification, deviation/non-conformance, CAPA, training, product quality complaints, adverse events, and stability in accordance with FDA regulations. Responsibilities include developing and implementing SOPs, championing continuous improvements to Quality Systems, ensuring regulatory inspection readiness, reviewing and approving specifications, defining and monitoring compliance metrics, and participating in cross-functional teams. The role also involves working with internal and external companies to establish quality frameworks, providing coaching and mentoring to the QA team, maintaining open communication channels, performing management tasks for the team, and executing end-to-end quality strategy from product development to commercialization.