Responsibilities of the position include establishing and maintaining quality and compliance processes associated with sterile manufacturing and operations from the onset of building and qualifying the facility, leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications. · Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.