IT Compliance Professional

Novo Nordisk; Gladsaxe Kommune; On-site; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk is seeking a Senior IT Compliance Professional to ensure IT and automation systems behind manufacturing are compliant, reliable, and ready for future needs. Two candidates will join sites in Bagsværd and Hillerød to shape risk-based validation strategies for GxP computerised systems, infrastructure, and AI/ML technologies.

You will advise on validation plans, reports and test strategies, participate in audits, and drive the adoption of new quality and regulatory requirements across

Qualifications

• Experience with IT validation and compliance in a GxP-regulated environment.
• Strong knowledge of regulatory requirements and quality assurance methods.
• Ability to communicate with colleagues and management, take ownership and deliver independently.

Responsibilities

• Define and support risk-based validation strategies for computerised systems, infrastructure and AI/ML applications in line with GxP, cGMP and GAMP 5.
• Advise on validation plans, reports, test strategies and other deliverables; support reviews as required.
• Represent the department during audits and inspections, coordinating handling of 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 and training requirements.
• Lead local projects and process improvements with consideration of operational management in IT projects.

Skills

GxP compliance

IT validation

Regulatory compliance

Quality assurance

GAMP 5

Stakeholder communication

English fluency

Independent planning

Education

Bachelor's or Master's in CS/engineering/life sciences

Job description

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 the people who need them – and reliable, compliant technology is part of making that happen. Day to day, you will work closely with local stakeholders at your site, alongside colleagues across IT functions, quality, manufacturing sites and external suppliers to align compliance initiatives. You will contribute actively to cross-site compliance and validation networks and interact with global strategic partners. By bringing these perspectives together and creating clarity when things stall, you will help teams move at pace while keeping quality uncompromised.

What You Can Expect Here

You will be trusted to work independently and make your voice heard. Your expertise will shape how validation is done, from simplifying workflows to setting the approach for emerging technologies such as AI and machine learning. You will grow on the job through new technologies, cross-site networks and colleagues across functions, and you will coach and mentor others, sharing what you know and raising the bar together.

What We Offer

At Novo Nordisk, you'll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage.

Salary

For this role, the Annual Base Salary ranges from 651,000 DKK to 956,900 DKK corresponding to the level of the position. The placement within the salary range will be assessed during the recruitment process based on the candidate's

Incentives and Benefits

The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

Learn more about our Reward Philosophy here.

Equal Opportunity Statement

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