Provide strategic direction and leadership to ensure effectiveness of Quality Systems (e.g., CAPA, Change Management, Event Management, Supplier Quality, Internal Audit, Document Management, Risk Management, Record Review and Product Disposition, Training, Field Alert/Recall, etc.). The Director of Quality Assurance will work with their direct managerial reports, as well as Executive Leadership, to ensure a continued state of compliance while promoting a strong quality culture across the organization for all products, spanning early phase development to commercialization.