Senior IT Compliance Pro: GxP Validation & AI

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

Job summary

Novo Nordisk is seeking a Senior IT Compliance Professional for our Bagsværd and Hillerød sites in Denmark. You will shape risk-based validation strategies for GxP computerised systems, infrastructure and new tech including AI/ML, ensuring product quality and patient safety.

You will advise on validation plans and deliverables, represent the department during audits, and drive adoption of new quality and regulatory requirements across IT and business units.

Qualifications

• Bachelor's or master's degree in computer science, engineering, life sciences or a related field.
• 3–5 years of IT validation and compliance experience in a GxP environment.
• Hands-on experience validating computerised systems and infrastructure.
• Strong knowledge of regulatory compliance requirements and GAMP 5.
• Ability to communicate with colleagues and management and work independently.
• Ability to collaborate across functions and international teams.

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, and support reviews when 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.
• Maintain and simplify local process landscape, including SOPs and training materials.
• Lead local projects and process improvements ensuring IT project alignment with operational needs.

Skills

IT validation

GxP compliance

Regulatory compliance

Stakeholder communication

English fluency

Education

Bachelor's or Master's in CS/Engineering/Life Sciences

Job description

Novo Nordisk is seeking a Senior IT Compliance Professional for our Bagsværd and Hillerød sites in Denmark. You will shape risk-based validation strategies for GxP computerised systems, infrastructure and new tech including AI/ML, ensuring product quality and patient safety.

You will advise on validation plans and deliverables, represent the department during audits, and drive adoption of new quality and regulatory requirements across IT and business units.