Associate Director, Facilities
Core
Ensuring D&G QMT US facilities and equipment are maintained at operational readiness in a cGMP and ISO 13485 compliant state, overseeing preventive maintenance and equipment lifecycle programs.
Role type
Senior IC facilities manager (cGMP/medical device)
Builds
Operational facility infrastructure and equipment reliability for medical device manufacturing
Domain
Medical device manufacturing / cGMP regulated environment
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, ISO 13485 quality system, preventive maintenance planning, team leadership, budget management, SOP development, change-order management, vendor coordination, root cause analysis, business continuity planning
Preferred skills
Hazardous and biomedical waste management, in-sourcing calibration activities, CAD/Visio design software, PLC and electronic systems troubleshooting
Technologies
CMMS (Faciliworks), HVAC, Electrical, Plumbing, PLCs, refrigeration, water systems, cold storage equipment
Responsibilities
Lead and develop a team of facilities staff to fulfill department mission; Manage Facilities Budget and serve as key stakeholder in Capital Budget; Write change-orders and create, review and revise Standard Operating Procedures (SOPs); Manage core services including Utilities, Fire Safety, Property Insurance and Vendor Managed Services; Oversee Water System, Cold Storage Equipment & Temperature Monitoring program; Coordinate with Supply Chain, Quality and Science & Technology teams for asset selection, installation, and maintenance; Ensure Business Continuity & Disaster Recovery (BCDR) plans are up-to-date; Provide on-call support for off-hours emergencies.
Seniority
Senior, hands-on IC with team management