Validation & Compliance Specialist

Cph Ai Hub; Aalborg; On-site; DKK 743,000 - 1,092,000; Full time

Job summary

Novo Nordisk seeks a Validation & Compliance Specialist in Denmark to drive validation of clinical data science processes using AI, ensuring fit-for-use before study data touch it. You will help build AI validation expertise in GCP-regulated environments and support responsible AI in clinical research.

You will collaborate with QA, data scientists, IT and external partners to assess risks, prepare validation plans and manage deviation handling, change control and documentation, with emphasis on

Qualifications

• A degree in information technology, computer science, engineering, data science or related discipline.
• Extensive experience in validation and compliance in pharma/biotech/medical devices or clinical research.
• Strong understanding of risk-based validation, data integrity and change control.
• Ability to evaluate how systems and supplier services support controlled workflows.
• Interest in AI validation with motivation to develop expertise.
• Excellent written and spoken English; strong communication skills.

Responsibilities

• Drive validation planning and coordination for new or updated clinical data science processes.
• Assess and document process risks with the Project Clinical Data Scientist.
• Prepare and maintain Process Validation Plans and Reports and secure approvals.
• Run risk-based walkthroughs, perform reviews, document findings and coordinate corrective actions.
• Assess changes and incidents for impact and determine needed validation.
• Support AI System Responsible in defining context of use, model risk and evaluation criteria.
• Coach colleagues and improve validation templates, procedures, and training.

Skills

Validation experience

Regulatory knowledge

Risk assessment

Documentation skills

Stakeholder management

English proficiency

Education

IT/CS/Engineering degree

Tools

Python

R

Quality Management System

Job description

Validation & Compliance Specialist

Department: AI Governance

Location: Søborg or Aalborg, Denmark

Your impact begins here

You will drive the validation of clinical data science processes, including those that use AI and emerging data types, so they are fit for intended use before they touch study data. By spotting defects and weighing risks early, you protect patient safety, data integrity and clinical results. You will also help build Novo’s AI validation expertise in Good Clinical Practice (GCP) environments, shaping how AI is used responsibly in clinical research.

What you’ll bring

You bring a strong validation and compliance background and the initiative to find risks before they affect clinical results.

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

Useful but not essential

Experience with GCP-regulated clinical research, clinical data science, analytical workflows, AI evaluation or governance, Python or R programming, open-source components, reproducible analyses, automated testing, or audits and inspections.

An established AI validation specialisation is desired but not a prerequisite. We welcome experienced validation professionals who want to grow in this area.

What you’ll do

• Drive validation planning and coordination for new or updated clinical data science processes, from data ingestion and preparation through analysis, output verification and finalisation.
• Assess and document process risks with the Project Clinical Data Scientist, who owns the process, linking intended use and requirements to controls that protect patient safety, data integrity and clinical results.
• Prepare and maintain Process Validation Plans and Reports, assemble supporting evidence and secure the required approvals before production use. Work with relevant owners to assess system validation, infrastructure qualification, supplier controls and script or open-source reviews.
• Run risk-based walkthroughs and spot checks, and perform Process Validation Reviews after use on study data and before deliverable lock. Document findings, escalated unresolved risks and coordinate corrective actions and revalidation.
• Assess changes, deviations and incidents for their impact on processes, previously processed data and results, and decide what validation is needed.
• Support the AI System Responsible and AI specialists in defining context of use, model risk, evaluation criteria and human oversight. Challenge evaluation evidence, data quality and bias assessments, and assess risks in AI and digital-device workflows, including provenance, manual annotations, audit trails and reproducibility.
• Coach colleagues, use findings to improve validation templates, procedures and training, and explain the validation approach in audits and inspections.

Who you’ll work with

You will be a member of a validation team within AI & Digital Innovation, part of Research & Development. Day to day, you will work with Quality Assurance (QA) colleagues, data scientists, AI specialists, software developers, IT solution owners, platform teams, validation engineers, data and AI governance colleagues, and external partners.

Your closest partner on each process is the Project Clinical Data Scientist who owns it. Together with QA and technical colleagues, you will keep risks visible, decisions clear and actions moving.

The role involves occasional business travel, typically 4–5 times per year, with trips lasting approximately 3–5 days. These visits will primarily support participation in conferences, knowledge-sharing events, and in-person collaboration with local and cross-functional team members. The travel is intended to strengthen team alignment, foster collaboration across sites, and support professional development through engagement with the broader scientific, AI, and validation communities.

What you can expect here

You will work with experts across science, technology and quality, where your judgement is valued and your voice is heard. You will build new skills in AI validation and governance while applying the expertise you already have, supported to perform at your best and trusted to take ownership.

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. As we continue our digital transformation journey, you’ll find exciting opportunities to grow your expertise while working alongside talented colleagues who share your passion for excellence. When you join us, you’re not just optimising processes – you’re enabling innovations that span generations.

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 742,600.00 DKK to 1,091,600.00 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 skills, competencies, knowledge, and relevant experience.

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: https://www.novonordisk.com/careers/working-at-novo-nordisk/total-rewards-benefits.html

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