Associate Director, GxP Operations Support Manufacturing Systems
Core
Strategic leadership for the design, delivery, administration, and continuous improvement of Manufacturing Execution Systems (MES) and manufacturing control system platforms supporting commercial and clinical operations.
Role type
Associate Director, GxP Operations Support Manufacturing Systems
Builds
MES platforms, manufacturing control systems, and digital manufacturing capabilities for commercial and clinical operations
Domain
Biopharmaceutical manufacturing, GxP compliance, industrial automation
Deliverable
production ML models | product features | infrastructure
Required skills
MES platform strategy, GMP/GAMP compliance, validation lifecycle management, industrial automation architecture, data integrity principles, cybersecurity assurance, stakeholder leadership, KPI definition
Preferred skills
Advanced degree, POMSnet MES experience, historian platform integration, analytics solutions
Technologies
MES platforms, PLCs, HMIs, SCADA, historian platforms, electronic batch record solutions
Responsibilities
Develop strategic roadmap for MES digitalization, drive standardization and best practices, ensure deployment and lifecycle management, establish and monitor KPIs, provide technical coaching and leadership
Seniority
Senior, strategic leadership with hands-on technical guidance
