Senior AI Validation & Compliance Specialist

Cari; Aalborg; On-site; DKK 743,000 - 1,092,000; Full time

Job summary

Novo Nordisk seeks a Validation & Compliance Specialist in Søborg or Aalborg, Denmark, to ensure clinical data science processes are fit for use with robust, auditable evidence. You will drive validation planning, document risks, and support AI governance in GCP-regulated environments.

You will collaborate with QA, data scientists and IT to ensure controlled workflows, model evaluation, bias checks and human oversight, while advancing validation capability across the organization.

Qualifications

• Degree in information technology, computer science, engineering, data science, life sciences or related discipline, or equivalent professional experience.
• Substantial experience in validation and compliance in pharmaceuticals, biotechnology, medical devices or clinical research, including leading validation activities.
• Strong understanding of risk-based validation, data integrity, testing evidence, change control, deviation handling and a quality management system.
• Ability to evaluate how systems, integrations, infrastructure and supplier services support controlled, reproducible workflows.
• Interest in AI validation, including model evaluation, bias, human oversight and monitoring, and motivation to develop expertise.
• Ability to turn complex technical and scientific information into clear validation requirements and documentation, with excellent written and spoken English.
• Strong planning and stakeholder management skills, sound judgement, and ability to guide colleagues across disciplines.
• Proactive, investigative approach: initiate reviews, challenge assumptions, prioritize findings and follow corrective actions.

Responsibilities

• Drive validation planning and coordination for new or updated clinical data science processes from data ingestion to finalisation.
• Assess and document process risks with the Project Clinical Data Scientist, linking intended use to controls.
• Prepare and maintain Process Validation Plans and Reports and secure required approvals before production use.
• Run risk-based walkthroughs and spot checks, document findings and coordinate corrective actions and revalidation.
• Assess changes, deviations and incidents for impact on processes and data, deciding needed validation.
• Support AI System Responsible and AI specialists in defining context of use, model risk and evaluation criteria.
• Coach colleagues and improve validation templates, procedures and training; explain validation in audits and inspections.

Skills

Validation

Compliance

Risk assessment

Data integrity

Change control

Documentation

Stakeholder management

AI validation interest

English communication

Education

Degree in IT/CS/Engineering/Data Science or Life Sciences

Tools

Python

R

Open-source tools

Job description

Novo Nordisk seeks a Validation & Compliance Specialist in Søborg or Aalborg, Denmark, to ensure clinical data science processes are fit for use with robust, auditable evidence. You will drive validation planning, document risks, and support AI governance in GCP-regulated environments.

You will collaborate with QA, data scientists and IT to ensure controlled workflows, model evaluation, bias checks and human oversight, while advancing validation capability across the organization.