Senior IT Compliance & Validation Specialist

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

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