About the Job

Join our team as an IT Compliance Specialist to ensure our systems, processes, and data handling meet the highest regulatory and security standards. Although your primary focus will be on systems used at the Hungarian sites, as part of a global team you will also have an impact on the development of corporate processes, procedures, and methodologies in a dynamic, technology-driven environment.

Main Responsibilities

• Ensure compliance of GxP software systems with applicable regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5, EU NIS2)
• Participate in procurement, development, configuration, validation, and implementation of software applications
• Prepare, review, and approve Computerized System Validation deliverables, including validation plans, risk assessments, test protocols, and reports
• Support periodic reviews, changes, corrective-preventive actions and re-validation activities for existing systems
• Collaborate with cross-functional teams (QC, IT, QA, Production, vendors) to ensure timely project execution and system compliance
• Provide training, guidance, and technical support to staff on validated software systems
• Contribute to audit readiness by maintaining accurate documentation and supporting regulatory or customer inspections

What We Expect

• Bachelor’s degree in Life Sciences, Computer Science, Engineering, or a related field
• Fluent in Hungarian and English (spoken and written)
• 4+ years of experience in a GxP-regulated environment
• 2+ years hands-on CSV experience

Sounds like you?

• Strong analytical and data integrity–focused mindset
• Ability to work independently and as part of a team
• Open minded, and enjoy continuous learning
• Interested in software solutions and applications

What We Offer

• Competitive compensation and benefit package
• „Nordic-style” culture – dynamic teamwork, good working atmosphere, flexibility, maintaining work-life balance
• Opportunity to learn and develop
• Good team spirit and friendly colleagues
• Stable international company background
• Multinational working environment
• Home office opportunity

Xellia Pharmaceuticals is the global leader in fermentation-based, non-beta-lactam anti-infectives, supplying Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs) to over 500 pharmaceutical companies across 80 countries.

Recognized by the World Health Organization and the European Union for our critical medicines, we play a vital role in combating severe infections and antimicrobial resistance. Headquartered in Denmark, we operate manufacturing sites in Copenhagen, Denmark; Budapest, Hungary; and Taizhou, China, with R&D and commercial operations in seven additional locations globally. As the only European manufacturer of several key anti-infectives and with a heritage spanning over 120 years, we are driven by purpose and progress.

With more than 1100 employees, our impact starts from within. We offer a workplace where ideas, curiosity, and initiative thrive, and where your role evolves with your ambition. Instead of rigid structures, we provide real responsibility, freedom to explore, and support to grow. Together, we shape not only the future of our company and the development of our people, but also the health of communities worldwide.

Further information about Xellia can be found at: www.xellia.com
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