Compliance and Validation Specialist

Compliance and Validation Specialist

Bring your expertise in IT compliance and validation to a role where every system you safeguard helps deliver life-saving medicines to millions of patients. If you thrive at the intersection of IT quality and manufacturing and want your work to have real regulatory and patient impact this is your opportunity to shape how compliance is done across our global API manufacturing IT landscape.

Your new role
As our new Compliance and Validation Specialist you will be a key driver of IT compliance and validation activities across the API manufacturing IT landscape ensuring that systems and solutions meet regulatory quality and security standards throughout their lifecycle. You will join a cross-functional team covering Compliance various IT systems IT Security and Audits & Inspections working closely with compliance specialists IT teams and centres of excellence across the organisation.

Day-to-day your tasks will include:

• Leading and supporting computer system validation (CSV) activities in alignment with GxP requirements and developing and maintaining validation documentation such as URS risk assessments qualification protocols (IQ/OQ/PQ) and validation summary reports
• Acting as the subject matter expert and go-to resource for IT compliance and validation topics within the API IT organisation ensuring systems remain in a compliant state throughout their lifecycle
• Serving as a key contact during internal audits and regulatory inspections preparing teams and documentation for audit readiness and coordinating responses to findings and CAPAs
• Collaborating with IT Security stakeholders on security risk assessments and supporting remediation of identified gaps
• Partnering with the PI Center of Excellence (PI CoE) DCS Center of Excellence (DCS CoE) and global and local quality manufacturing and IT stakeholders to align on standards and best practices
• Driving continuous improvement of compliance processes tools and methodologies and translating evolving regulatory requirements (FDA EMA GAMP5) into actionable guidance

Your new department
In Global Manufacturing & Supply we cover the full value chain from drug and device development to marketed Novo Nordisk products. We are more than 30000 colleagues across the globe with the shared responsibility of scaling molecules processes devices and products dedicated to supplying life-saving medicines to the patients who need them most.

You will join the Cross IT team within GMS API IT Manufacturing Solution a collaborative networked team sitting at the crossroads of IT quality and manufacturing. Together we ensure that the systems powering API production are compliant secure and audit-ready so our colleagues on the manufacturing floor can focus on delivering for patients. Your expertise will directly shape how we embed compliance into system design implementation and daily operations across the API area.

Your skills & qualifications
We are looking for a proactive quality-driven specialist who enjoys explaining complex compliance topics to both technical and non-technical audiences and who thrives in a cross-functional environment. Ideally you bring with you:

• A Bachelors or Masters degree in a relevant field such as Computer Science Engineering or Life Sciences
• Minimum 8 years of experience in IT compliance validation or a related field within a GxP-regulated environment with solid knowledge of GAMP5 21 CFR Part 11 EU Annex 11 and relevant ICH guidelines
• A strong understanding of IT systems used in pharmaceutical manufacturing (e.g. MES SCADA/DCS historians/PI systems) ideally with hands-on experience in an Active Pharmaceutical Ingredient (API) manufacturing environment
• A proven track record of independently leading end-to-end CSV projects using risk-based validation approaches and of acting as a primary contact during health authority inspections (e.g. FDA EMA) and internal audits
• Nice to have: familiarity with IT Security frameworks (ISO 27001 NIST) data integrity principles cloud/SaaS in a GxP context eQMS and validation management tools and OSIsoft PI systems or DCS platforms
• Excellent communication skills in English with a structured analytical mindset and the ability to manage multiple priorities simultaneously

What we offer

At Novo Nordisk youll 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 742600.00 to.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 candidates 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 here..

More information

If you have any questions about the position please do not hesitate to contact Maria Thrane at .

Deadline

16 July 2026. We expect to have 1st interviews in the start of August. You do not need to attach a cover letter to your application but please include a few sentences about your motivation in your resume or CV. To ensure an efficient and fair recruitment process please refrain from adding a photo to your CV.

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

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.