Associate Director of IT Operations, GMP IT/OT
Core
Lead IT/OT infrastructure operations and compliance for GxP manufacturing environments, ensuring reliable service delivery and regulatory adherence.
Role type
Senior Manager or Associate Director of IT Operations (GMP/OT)
Builds
Robust, secure, and scalable IT/OT infrastructure and services for life-science manufacturing
Domain
Life Sciences / GxP Manufacturing / IT Operations
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
IT/OT infrastructure management, GxP/FDA compliance, ITIL practices, vendor management, disaster recovery planning, team leadership, Microsoft Server/GPO, hyper-converged systems, advanced networking
Preferred skills
DeltaV/Emerson, Rockwell/Allen-Bradley, PIC/S, 21 CFR Part 11, Annex 11, GAMP
Technologies
Microsoft Server, GPO, DeltaV, Emerson, Rockwell, Allen-Bradley
Responsibilities
Ensure reliable operation of IT/OT infrastructure including servers, hardware, communications, and networks; Define and lead IT/OT infrastructure architecture; Maintain compliance with GxP, FDA, and global regulatory requirements; Manage service providers and act as escalation point for major incidents; Lead, mentor, and develop diverse technical teams; Drive implementation of ITIL practices and operational best practices
Seniority
Senior Manager (8+ years exp, 8+ years management) or Associate Director (10+ years exp, 10+ years management)
