*** 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 harry@qpexec.com
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