IT Compliance Professional

Your impact begins here As Senior IT Compliance Professional, you will help make sure the IT and automation systems behind our manufacturing are compliant, reliable and ready for what comes next. We are looking for two candidates: one to join our site in Bagsværd and one to join our site in Hillerød. You will shape risk-based validation strategies for GxP computerised systems, infrastructure and new technologies such as AI and machine learning. Your clear guidance will help projects and operations move forward with confidence, while protecting the product quality and patient safety that people living with serious chronic diseases rely on every day. What you’ll bring You know IT validation from the inside and can turn complex compliance requirements into practical direction.  You will also bring: A bachelor’s or master’s degree in computer science, engineering, life sciences or a related field. 3–5 years of experience with IT validation and compliance in a GxP-regulated environment. Hands-on experience validating computerised systems and infrastructure. Strong knowledge of regulatory compliance requirements, quality assurance methods and GAMP 5. The confidence to communicate with colleagues and management, take ownership and plan and deliver your work independently. The ability to create results across functions, cultures and virtual international teams, and to navigate differing stakeholder interests with sound business understanding. Fluency in English. Useful, but not essential: Experience within cGMP. Experience validating AI or machine learning technologies. What you’ll do You will be a trusted compliance advisor to both IT and the business, influencing decisions across organisational areas and helping introduce right-sized approaches to new technologies without losing a strong compliance foundation. Define and support risk-based validation strategies for computerised systems, infrastructure and AI and machine learning applications, in line with GxP, cGMP and GAMP 5 principles and internal requirements. Advise on validation plans, reports, test strategies and other deliverables, and support reviews when required. Represent the department during audits and inspections, and coordinate the effective handling of compliance gaps and findings. Drive implementation of new quality and regulatory requirements, and provide ad hoc compliance guidance to projects and operations. Maintain and simplify the local process landscape, including SOPs, guides, training requirements and supporting instructions. Lead local projects and process improvements, making sure operational management is considered in IT projects. Who you’ll work with You will join one of the IT/Automation functions in Global Manufacturing & Supply IT, working where IT, automation, quality and manufacturing meet. In Global Manufacturing & Supply, colleagues work across the value chain to scale processes and products for…