Good Manufacturing Practices Facilities Operations Manager Winship Cancer Institute

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.

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 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.
  
  

MINIMUM QUALIFICATIONS:

• Bachelors 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.
• Previous supervisory experience preferred.
• Essential Skills & Qualification: 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.

NOTE: Position tasksaregenerallyrequired tobe performed in-person at an Emory University location.Remote workfrom homedayoptions may be grantedatdepartmentdiscretion.Emory reserves the right to changeremote workstatus with notice toemployee.

Emory is an equal opportunity employer and qualified applicants will receive consideration for employment without regard to race color religion sex national origin disability protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions educational programs or employment including recruitment hiring promotions transfers discipline terminations wage and salary administration benefits and training. Students faculty and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Assistance Act and applicable executive orders federal and state regulations regarding nondiscrimination equal opportunity and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance 201 Dowman Drive Administration Building Atlanta GA 30322. Telephone: (V) (TDD).

Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation please contact the Department of Accessibility Services at or call (Voice) (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.