Senior IT QA Compliance Manager

Are you passionate about ensuring IT compliance in highly regulated environments while working across multiple global departments? Are you a skilled and experienced Senior IT QA Compliance Manager ready to join Global Quality?

This position focuses on ensuring compliance of IT Systems with linked processes and providing support to IT systems and projects globally with the primary focus on the functional areas Global Business IT, Product Supply and Global Business Operations.


The position
As the Senior IT QA Compliance Manager, you will support the areas above with:

Operational tasks:

• Guidance and support to ensure compliance with IT specific regulatory compliance requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, new EU Annex 21) and internal quality processes.
• Oversee and review quality documentation for IT systems and processes, such as GxP determinations, validation plans, validation reports, system lifecycle documentation, risk assessments, supplier management activities and test documentation.
• Provide training to stakeholders in ALKs Quality Management of Computerized Systems processes.
• Handle Change Controls, Deviations, CAPAs and SOP/WIN approvals.
• Provide ad hoc expertise to critical issues.

Project Participation:

• Actively participate in Global Quality (GQ) improvement initiatives to enhance efficiency and quality within IT systems with linked processes e.g., data integrity, computerized equipment and IT supplier management.
• Drive and ensure implementation of new regulatory requirements in ALKs Quality Management of Computerized Systems processes.
• Provide IT QA expertise during the implementation of IT systems supporting the areas described above.

Lead Auditor:

• Plan, execute, report and follow up on audits of suppliers of IT systems supporting Global Business IT, Product supply, Commercial Operations, Pharmacovigilance, Clinical development and Regulatory Affairs. This to assess compliance with regulatory requirements and quality standards.
• Plan, execute, report and follow up on internal audits of IT systems globally in ALK.
• Facilitate and provide support for external audits and inspections from authorities (e.g., FDA, DKMA).

Your profile
We expect that:

• You hold an academic degree in Engineering, Pharmacy, or Natural sciences. You have at least 10 years of experience from the pharmaceutical or medical device industry and within GxP, and are experienced with areas such as cloud-based systems, outsourced IT services, automated testing etc.
• Have extensive experience with QA and IT systems, demonstrating a strong understanding of quality management of IT systems and tools.
• Have experience with audits as Lead Auditor or participation in audits and inspections as SME.
• Experience with implementation of SAP S/4 HANA will be an advantage.

Your personal characteristics:

• Possess high drive and you take initiative and proactive action.
• Ability to work independently but also being a team player.
• Relation builder working respectfully across different cultures with flexibility.
• Strong cross-cultural communication skills and fluent in both spoken and written English and Danish.

Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism, integrity, and an open-minded approach contributing to an inspiring and fun working environment. You will be part of an engaged and informal team who values skill and knowledge creation. The result of your efforts will be significant throughout the organization, and you will be able to actively influence and challenge the status quo.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 5 January 2026.

We commit to an inclusive recruitment process and equal opportunity for all our job applicants. Hence, we prefer that you do not add images to your application documents. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

Do you want to learn more about our company, we encourage you to visit us at [xxxxx] are looking forward to hearing from you!