Good Manufacturing Practices Facilities Operations Manager - Winship Cancer Institute

Emory University•Atlanta, GA

3d•Onsite

About The Position

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.

Requirements

Bachelor's degree in engineering, facilities management, or business administration and 4+ years experience overseeing facility operations for a GMP facility or an equivalent combination of education and experience.
Experience in regulated environments (pharma/biotech), strong knowledge of FDA/GMP regulations, quality systems (SOPs, validation, audits) is required.
Strong understanding of GMP, GDP (Good Distribution Practices).
Experience with HVAC, WFI, steam systems.
Leadership, communication, problem-solving, and project management.
Ability to work in hazardous/cleanroom environments and handle physical demands.
Leadership skills to manage a team and critical infrastructure, ensuring a compliant and validated operating environment.

Nice To Haves

Previous supervisory experience preferred.

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 documentation, CAPAs, and lead audits.
Oversees preventative/predictive maintenance for critical systems (HVAC, WFI, refrigeration) and equipment.
Selects, manages, and coordinates external service providers for projects and maintenance.
Develops, manages, and controls facility budgets; oversees facility upgrades and capital projects.
Manages gowning, cleaning/sanitization programs, and product changeovers.
Enforces safety protocols, leads equipment/environment specific risk assessments, and ensures environmental compliance.
Works with QA/QC, Production, and other departments.
Performs related responsibilities as required.