Role highlights
Full Time
Permanent
Senior
On-site
The Senior IT Validation & Compliance Partner role requires extensive experience in IT system validation within regulated industries such as pharmaceuticals and biotech. Candidates should have at least five years of hands-on experience ensuring compliance with GxP regulations and industry standards including GAMP 5, FDA 21 CFR Part 11, and EU Annex 11. The position involves leading Computerized System Validation (CSV) activities and managing data integrity compliance for IT systems, with a strong emphasis on developing and reviewing validation documentation such as protocols, reports, and risk assessments. Expertise in emerging technologies including AI, software development, and scripting languages like Python and PowerShell is essential to support automation and validation processes. The role demands collaboration across IT, Quality, and Business teams to maintain validated systems throughout their lifecycle and to facilitate communication between business subject matter experts, developers, testers, and quality assurance teams. Experience supporting audits and inspections by demonstrating robust validation practices is critical. A bachelor’s or master’s degree in computer science, engineering, or a related field is required, with a preference for candidates holding a master’s degree. Strong verbal and written communication skills and stakeholder management capabilities are necessary to succeed. Additional desirable skills include familiarity with cloud-based systems, cybersecurity principles, automation frameworks, digital transformation projects, and agile methodologies. The role suits a proactive, detail-oriented, and self-driven professional capable of working independently within a global R&D technology delivery environment focused on digital transformation and regulatory compliance.
About the role
Role Summary
Join our global R&D Tech Delivery organization as a Senior IT Validation & Compliance Partner. Drive digital solutions while ensuring they meet the highest regulatory standards. Shape the future of IT validation, especially for emerging technologies like AI-driven solutions, software development, and automation scripting. Collaborate with a team of eight validation specialists to continuously improve our IT validation approach and support Novo Nordisk’s digital transformation.
Responsibilities
- Lead validation activities for IT systems, including Computerized System Validation (CSV) and data integrity compliance
- Develop and review validation documentation (protocols, reports, risk assessments) in alignment with GAMP 5 and global regulatory guidelines
- Partner with IT, Quality, and Business teams to maintain a validated state throughout the system lifecycle
- Serve as a bridge between Business SMEs, Developers, Testers, and Quality teams to ensure effective communication and alignment
- Support internal and external audits/inspections by demonstrating robust validation practices and preparedness
Requirements
- Bachelor’s or master’s degree in computer science, engineering, or a related field
- Minimum 5 years’ experience in IT system validation within regulated industries (pharmaceutical, biotech, or similar)
- Strong working knowledge of GxP regulations and industry standards (GAMP 5, FDA 21 CFR Part 11, EU Annex 11)
- Hands-on experience with AI technologies, software development, and scripting languages (e.g. Python, PowerShell) as they relate to system validation and automation
- Excellent verbal and written communication skills with proven stakeholder management abilities
- Proactive approach with keen attention to detail; self-driven and capable of working independently
Nice to Have
- Familiarity with cloud-based systems, cybersecurity principles, and automation frameworks
- Experience contributing to digital transformation projects and using agile methodologies
Benefits
- Opportunities to learn and develop within a global healthcare company
- Benefits designed to support your career and life stage
- Unique culture focused on purpose, mutual respect, and going beyond conventional solutions
How to Apply
- For further information, contact Morten Viggo Larsen (Associate Director, IT Compliance and Validation) at [email protected]
- Submit your application by 31 January 2026
- Novo Nordisk is committed to an inclusive recruitment process and equality of opportunity for all applicants
At Novo Nordisk, we are dedicated to defeating serious chronic diseases and helping millions live healthier lives. Our work is driven by curiosity, determination, and a commitment to lasting change in healthcare.
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