Monitor, measure and report on quality issues, opportunities and development plans and achievements within agreed formats and timelines to direct reports as well as department leaders in Manufacturing, Compliance, Facilities/Engineering, Supply Chain, Quality Control, Human Resources as well as Senior Management. Provide operational leadership and expertise in the development, implementation, and training of cGMP compliant quality systems, such as document control, change control, investigations, deviations, CAPA, and product quality complaints.