QA IT Specialist

We are seeking a Quality Assurance IT Specialist to join our Global Quality - IT QA team.

In this role, you will be responsible for supporting the governance, compliance, and quality oversight of global GxP-relevant IT systems and infrastructure.

You will contribute to ensuring system integrity, data integrity, and operational reliability throughout the system lifecycle.

You will play a key role in maintaining and continuously improving global quality standards, ensuring that IT systems are implemented, validated, and operated in compliance with applicable regulatory requirements and industry standards across all regions.

Quality Assurance IT Specialist

• Ensure 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)
• Develop and maintain global quality standards for regulated IT systems
• Collaborate with IT teams on risk management, validation, and implementation of compliant system controls
• Support internal and external audits by ensuring compliant documentation and GxP-aligned IT processes
• Drive continuous improvement of IT quality standards to meet evolving regulatory expectations
• Work cross-functionally with IT, IT Compliance, Quality, Manufacturing, and Development teams to optimize systems from a quality perspective

Key Qualifications

• Degree in Life Sciences, Computer Science, or a related field
• 5+ years of experience in IT Quality Assurance within the pharmaceutical or life sciences industry
• Strong expertise in regulatory requirements for regulated IT systems (e.g., FDA 21 CFR Part 11, EU GMP Annex 11, GxP)
• Proven experience leading IT system validation, risk management, data integrity, and audit activities in GMP-regulated environments
• Solid experience working within GMP-regulated pharmaceutical manufacturing and development settings
• Excellent stakeholder management, communication, and collaboration skills across IT, Quality, and operational functions
• Strong analytical mindset with the ability to assess complex quality risks and drive pragmatic, compliant solutions

Why join us?

• We offer great collegiality, and daily team meets 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!

Apply by clicking the ‘APPLY’ button. We are interviewing on an ongoing basis and look forward to receiving your CV. A cover letter is not required.

Applications submitted via email will not be considered.

We kindly request that headhunters or recruitment agencies refrain from contacting us regarding this position.

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. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
www.bavarian-nordic.com

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