Quality Assurance IT Specialist

We are currently looking for a Quality Assurance IT Specialist to join our Global Quality IT Systems & Standards team. In this role, you will help ensure the integrity and compliance of our global IT infrastructure and systems, playing a critical role in maintaining global quality standards in accordance with regulatory requirements across all regions.

The role of Quality Assurance IT Specialist

• IT Quality Assurance: Ensure that global IT systems supporting pharmaceutical operations comply with internal quality standards and regulatory requirements (e.g., FDA 21 CFR Part 11, EU GMP Annex 11, GxP)
• Global Standards Compliance: Develop and maintain quality standards for regulated IT systems worldwide
• Risk Management & Validation: Collaborate with IT teams to identify risks and implement controls to ensure compliance and system reliability
• Audit Support & Documentation: Support internal and external audits related to IT systems, providing necessary documentation and ensuring all IT-related processes are documented in compliance with GxP and other regulatory standards
• Continuous Improvement: Lead initiatives for the continuous improvement of IT quality standards and processes, ensuring that global IT systems remain state-of-the-art and compliant with evolving regulations
• Collaboration: Work closely with IT, IT Compliance, and our Quality teams to assess, implement, and optimize systems and processes from a quality perspective

Key Qualifications

• Degree in Computer Science or related fields
• 5+ years of experience in IT Quality Assurance or IT compliance-oriented role(s) within the pharmaceutical or regulated industry, with a focus on IT systems, software validation, or data integrity
• In-depth knowledge of regulatory requirements related to IT systems in the pharmaceutical industry (e.g., 21 CFR Part 11, EU GMP Annex 11, GxP)
• Experience with IT system validation, risk management, and audit processes in a regulated environment
• Strong communication and collaboration skills to work with cross-functional teams, including IT, Quality, Clinical, and regulatory departments
• Detail-oriented with strong analytical skills and the ability to solve complex quality issues

Why join us?

• We offer great collegiality, and daily team meetings to ensure alignment and support
• As we continue to grow, you will have a unique opportunity to make a real impact, shaping both the team and our QA processes
• We provide an international environment where personal and professional growth is prioritized
• Become part of a team that directly contributes to global health by manufacturing and developing life-saving vaccines
• Enjoy a vibrant staff club that offers a variety of diverse and exciting events

Ready to make a Difference? Apply Now!
We are interviewing on an ongoing basis and look forward to receiving your motivated CV, where you state your motivation for applying for this particular role. A cover letter is not required.

Please contact Director, QA for R&D & CSPV Claes Axang at , if you have any questions about the role.

For us, it is all about improving and saving lives
Improving and saving lives through innovative vaccines is at the heart of what we do in Bavarian Nordic. We are a fully integrated vaccine company focused on the development, manufacturing, and commercialization of life-saving vaccines and the largest pure-play vaccine company in the world.

In Bavarian Nordic, we believe in the power of the team, and you will be part of a global team of more than +1600 dedicated employees with diverse backgrounds and viewpoints, who are bound together by our commitment to protect lives every day. We believe in creating an inclusive and flexible workplace with a strong focus on personal and professional development, because we need each other to take things further.

Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values – our Bavarian Nordic DNA, as we like to call it – are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer.

https://www.bavarian-nordic.com/

Location: Kvistgaard - Hejreskovvej 18