The Global Head of Digital Manufacturing and Quality Control is accountable for defining and executing the enterprise strategy for GxP manufacturing and laboratory digital systems
Job Summary
The Global Head of Digital Manufacturing and Quality Control is accountable for defining and executing the enterprise strategy for GxP manufacturing and laboratory digital systems.
This role provides global lifecycle ownership, governance, and standards for platforms, data, and recipes across manufacturing and QC laboratories, ensuring harmonized, compliant, and future-ready operations.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies.
Matching Summary
The Global Head of Digital Manufacturing and Quality Control is accountable for defining and executing the enterprise strategy for GxP manufacturing and laboratory digital systems.
Skills & Requirements
Must-have
GxP manufacturing and laboratory digital systems
Global lifecycle ownership and governance
Operational Technology (OT) strategy and roadmap
MES, OSI PI, and LIMS platforms
ISA-88/95 and Pharma 4.0 principles
21 CFR Part 11, Annex 11 compliance
Nice-to-have
Driving strategic partnerships with suppliers
Leveraging partner ecosystems for maturity
Fostering a culture of innovation
Process Excellence methodology
Working across countries and cultures
Key Requirements
15+ years work experience
5+ years in execution systems, OT, IT, and operations
Experience in process automation, MES, ISA S88 & S95
Direct experience with SCADA, DCS, MES, PAT, LIMS, OSI Pi
Experience building, managing, and deploying global systems
Demonstrated ability to influence at all organizational levels
Strong project management skills in biopharma manufacturing
Functional knowledge of cGMPs and FDA-regulated facilities