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: <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="color:black;margin-bottom:2.0pt;line-height:14.0pt;margin-top:0.0cm;margin-right:0.0cm;font-size:12.0pt;font-family:Aptos, sans-serif">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</li> <li style="color:black;margin-bottom:2.0pt;line-height:14.0pt;margin-top:0.0cm;margin-right:0.0cm;font-size:12.0pt;font-family:Aptos, sans-serif">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</li> <li style="color:black;margin-bottom:2.0pt;line-height:14.0pt;margin-top:0.0cm;margin-right:0.0cm;font-size:12.0pt;font-family:Aptos, sans-serif">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</li> <li style="color:black;margin-bottom:2.0pt;line-height:14.0pt;margin-top:0.0cm;margin-right:0.0cm;font-size:12.0pt;font-family:Aptos, sans-serif">Collaborating with IT Security stakeholders on security risk assessments and supporting remediation of identified gaps</li> <li style="color:black;margin-bottom:2.0pt;line-height:14.0pt;margin-top:0.0cm;margin-right:0.0cm;font-size:12.0pt;font-family:Aptos, sans-serif">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</li> <li style="color:black;margin-bottom:2.0pt;line-height:14.0pt;margin-top:0.0cm;margin-right:0.0cm;font-size:12.0pt;font-family:Aptos, sans-serif">Driving continuous improvement of compliance processes, tools and methodologies, and translating evolving regulatory requirements (FDA, EMA, GAMP5) into actionable guidance</li> </ul> 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 30,000 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: <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="color:black;margin-bottom:2.0pt;line-height:14.0pt;margin-top:0.0cm;margin-right:0.0cm;font-size:12.0pt;font-family:Aptos, sans-serif">A Bachelor's or Master's degree in a relevant field such as Computer Science, Engineering, or Life Sciences</li> <li style="color:black;margin-bottom:2.0pt;line-height:14.0pt;margin-top:0.0cm;margin-right:0.0cm;font-size:12.0pt;font-family:Aptos, sans-serif">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</li> <li style="color:black;margin-bottom:2.0pt;line-height:14.0pt;margin-top:0.0cm;margin-right:0.0cm;font-size:12.0pt;font-family:Aptos, sans-serif">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</li> <li style="color:black;margin-bottom:2.0pt;line-height:14.0pt;margin-top:0.0cm;margin-right:0.0cm;font-size:12.0pt;font-family:Aptos, sans-serif">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</li> <li style="color:black;margin-bottom:2.0pt;line-height:14.0pt;margin-top:0.0cm;margin-right:0.0cm;font-size:12.0pt;font-family:Aptos, sans-serif">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</li> <li style="color:black;margin-bottom:2.0pt;line-height:14.0pt;margin-top:0.0cm;margin-right:0.0cm;font-size:12.0pt;font-family:Aptos, sans-serif">Excellent communication skills in English, with a structured, analytical mindset and the ability to manage multiple priorities simultaneously</li> </ul> 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 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 <a href="https://www.novonordisk.com/careers/working-at-novo-nordisk/total-rewards-benefits.html">her</a><a href="https://www.novonordisk.com/careers/working-at-novo-nordisk/total-rewards-benefits.html">e</a>.. More information If you have any questions about the position, please do not hesitate to contact Maria Thrane at <a href="mailto:[email protected]">[email protected]</a>. 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, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've 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 what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're 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.

Compliance and Validation Specialist (Kalundborg, Region Zealand, DK) @ novonord

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