The specific duties of the Manager, Quality Assurance at APC assigned to own Drug Product, Facility, and Technical Operations include but are not limited to: Oversight of qualification, maintenance, and calibration activities for equipment, facilities, and utilities; labeling quality review and disposition of drug product, drug product chain of custody, and ancillary systems (including but not limited to: cleaning & sterilization, cleaning solution preparation, and environmental cleaning). The specific duties of the Manager, Quality Assurance at APC assigned to own Cleanroom Processing and Laboratory Operations include but are not limited to: Oversight of Avance Starting Material, Drug Substance, and Drug Product Processing processes, including weekly room release, environmental monitoring execution, sample management, gowning for the cleanrooms, process validation, and quarterly dose audits.