Job Informationen

Your tasks: Lead and develop a team of high-performing professionals in the areas of IT infrastructure quality and project/validation support for other groups. Ensure that the requirements for the qualification of computer system infrastructures are clearly defined in policies, corporate quality standards, VMPs, and standard operating procedures. Train sites and project teams in the respective procedures and standards. Working with other global quality personnel, develop Lonza’s policy and common approach to compliance of infrastructure with 21 CFR Part 11, EU GMP Annex 11, other regulatory guidance, and best IT practice. Ensure this is communicated effectively to all affected sites. Coordinate the qualification of global computer system infrastructures ensuring that appropriate actions are carried out and recorded in accordance with approved documented procedures and in compliance with regulatory requirements and Corporate Quality Standards. Ensure that the requirements for the qualification are communicated effectively to IT/OT, QA and other relevant personnel, including system owners (IT) and process owners (Business), within the Lonza organization. Ensure proper standards relating to GMP for IT infrastructure systems and services for software, hardware and networks have been developed and defined in order to enable effective and efficient validation activities to be carried out. In conjunction with IT/OT and sites, support the evaluation of new applications in the IT infrastructure area to identify qualification requirements. Develop, together with other department heads, comprehensive and compliant governance to streamline and continuously improve the qualification and validation practices for computerized systems at the global level. In cooperation with Data Integrity specialists and leaders, support and ensure data integrity policies and measures for electronic systems are in place, trained, and implemented. Your profile: University degree in Computer Science (BSc, MSc) with respective professional experience, with focus on IT Infrastructure Several years of experience in pharmaceutical GMP environment (IT, OT, QC laboratories, QMS, etc.) Very strong quality mindset and a solid understanding of Computer System Validation, as well as good knowledge of the respective GMP regulations Good understanding of quality management principles (e.g., ISO9001:2015, etc.) Fluency in English is a must, other languages are a plus.

Benötigte Skills

• Englisch
• Hardware
• Pharma
• Compliance
• Management / Führung
• Support
• Bachelor
• Master