Good Manufacturing Practices Facilities Operations Manager - Winship Cancer Institute

Job description

Discover Your Career at Emory University Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. Description: GMP Facility Operations Manager oversees the physical operations of the facility, ensuring Good Manufacturing Practices (GMP) compliance for facilities and equipment, managing vendors/service calls, and maintaining critical systems (HVAC, WFI) for product quality, safety, and regulatory adherence, often involving documentation, audits, and emergency response. KEY RESPONSIBILITIES: - Manages scheduling of equipment maintenance to meet FDA GMP guidelines. Establishes and oversees facility cleaning services and schedule. - Establishes equipment life cycle for anticipated annual repair/replacement costs. - Manages all equipment/room alarm systems. Interfaces with Emory Hospital for alarm notifications, establishes appropriate alarm response procedures. - Leads IQ/OQ/PQ for all equipment onboarding and qualification. - Ensures adherence to cGMP, FDA, and internal standards; manage documentati...