Head of Automation & IT

*** Head of Automation & IT Opportunity - Biologics CDMO *** QP Group is currently partnered with a biologics CDMO focussed across Drug Substance, Drug Product, Packaging and development. They're looking for a Head of Automation & IT to design, implement and oversee their automation and IT ecosystem from the ground up. Responsibilities: Build and maintain enterprise systems (ERP, MES, LIMS, eQMS) ensuring cybersecurity, data integrity, and seamless connectivity. Oversee automation systems across all functions (manufacturing, QC, packaging, warehouse, supply chain) without requiring direct process expertise. Implement advanced analytics, predictive models, and AI-driven insights to optimise processes, enhance decision-making, and support continuous improvement. Guarantee compliance with GMP, FDA (21 CFR Part 11), EMA Annex 11, and Data Integrity principles. Oversee Computer System Validation (CSV) and ensure all automated systems meet regulatory standards. Build and lead the IT/IoT & Automation team. Manage vendor relationships and technology partnerships Requirements: Degree in Automation Engineering, Industrial IT, Computer Science, or related field. Minimum 10 years in pharmaceutical/biopharmaceutical or regulated industry, with at least 5 years in a leadership role. Strong knowledge of

automation systems (DeltaV)

and enterprise IT platforms ( MES, ERP, LIMS, eQMS ). Proven experience in

GMP ,

FDA ,

EMA compliance , and computerised system validation. Please apply directly or via

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