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, including PAS, MES, OSI PI, and LIMS platforms
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, including PAS, MES, OSI PI, and LIMS platforms.
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, including PAS, MES, OSI PI, and LIMS platforms.
Skills & Requirements
Must-have
GxP manufacturing and laboratory digital systems
PAS, MES, OSI PI, and LIMS platforms
Global lifecycle ownership and governance
Operational Technology (OT) strategy and roadmap
ISA-88/95 and Pharma 4.0 principles
21 CFR Part 11, Annex 11 compliance
Strategic OT supplier partnerships
Nice-to-have
Innovation and emerging OT technologies
Positive and equitable working environment
Culture of curiosity and empathy
Process Excellence methodology
Key Requirements
15+ years work experience
5+ years in execution systems, OT, IT, and operations
Experience in process automation, MES, batch manufacturing
Direct experience designing, building, deploying automation systems
Experience running shop floor and lab systems globally
Proven track record influencing operational technology
Demonstrated ability to influence at all organizational levels
Ability to build, mentor, and grow a high performing team
Strong project management skills in biopharma manufacturing
Functional knowledge of cGMPs and FDA-regulated facilities