Sr IT Validation at Novo Nordisk, Inc.

Jobbeskrivelse:

Seneste jobinformation fra Novo Nordisk, Inc. til stillingen som Sr IT Validation. If the Sr IT Validation ledige stilling i Søborg matcher dine kvalifikationer, bedes du indsende din ansøgning eller dit CV direkte gennem den opdaterede Jobkos jobportal.

Bemærk venligst, at det ikke altid er nemt at søge job, da kandidater skal opfylde visse krav sat af virksomheden. Vi håber, at karrieremuligheden hos Novo Nordisk, Inc. til stillingen som Sr IT Validation nedenfor matcher dine kvalifikationer.

Sr IT Validation & Compliance Partner

Category: Digital & IT

Lokation:Søborg, Capital Region of Danmark, DK

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We are seeking an experienced Senior IT Validation & Compliance Partner. In this pivotal role, you will drive digital solutions while ensuring they meet the highest regulatory standards, shaping the future of validation in our global R&D organization.

Your New RoleAs the IT Validation & Compliance Partner in our global R&D Tech Delivery organization, you will join a collaborative team of eight validation specialists dedicated to continuously improving our IT validation approach. You will provide expert guidance on validation strategies for complex IT systems, ensuring compliance with regulatory requirements while enabling innovation in areas such as AI-driven solutions, software development, and automation scripting. You will play a key role in shaping IT validation frameworks for emerging technologies and supporting Novo Nordisk's digital transformation. Key responsibilities include:

• Lead Validation Activities: Define and lead validation activities for IT systems, including Computerized System Validation (CSV) and data integrity compliance.
• Documentation & Compliance: Develop and review validation documentation (protocols, reports, risk assessments) in alignment with GAMP 5 and global regulatory guidelines.
• Lifecycle Management: Partner with IT, Quality, and Business teams to maintain a validated state throughout the system lifecycle.
• Cross-Functional Collaboration: Serve as a vital bridge between Business SMEs, Developers, Testers, and Quality teams, facilitating effective communication and ensuring alignment.
• Audit Support: Support internal and external audits/inspections by demonstrating robust validation practices and thorough preparedness.

Your New Department:In Research & Development, you will be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs. In this environment, IT compliance and validation are critical enablers of our mission to bring effective treatments to patients worldwide.

Your Skills and Qualifications:To succeed in this role, you should have:

• Education & Experience: Bachelor's or master's degree in computer science, Engineering, or a related field, and a minimum of 5 years' experience in IT system validation within regulated industries (pharmaceutical, biotech, or similar).
• Regulatory Knowledge: Strong working knowledge of GxP regulations and industry standards such as GAMP 5, FDA 21 CFR Part 11, and EU Annex 11.
• Technical Proficiency: Hands-on experience with AI technologies, software development, and scripting languages (e.g. Python, PowerShell) as they relate to system validation and automation.
• Communication Skills: Excellent verbal and written communication skills with proven stakeholder management abilities. You can effectively bridge the gap between business and technology, conveying complex information to diverse audiences.
• Proactive Mindset: A proactive approach with keen attention to detail. You take ownership of tasks and projects, ensuring objectives are met efficiently and thoroughly. You are self-driven, capable of working independently, setting goals, and initiating actions to drive projects forward.

Besides that, it is appreciated if you have familiarity with cloud-based systems, cybersecurity principles, and automation frameworks and experience contributing to digital transformation projects and using agile methodologies.

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination, and a constant curiosity. For over 100 years, this unordinary mindset has seen us build a Virksomhed unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare Virksomhed means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Contact

For further information about the Stilling, please contact Morten Viggo Larsen (Associate Director, IT Compliance and Validation) at

Deadline

Please submit your application by 31 January 2026.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare.

Jobinfo:

• Virksomhed: Novo Nordisk, Inc.
• Stilling: Sr IT Validation
• Arbejdssted: Søborg
• Land: DK

Sådan indsender du en ansøgning:

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