Associate Director, IT Compliance

Are you passionate about GxP compliance, SOX and other regulatory frameworks, and enabling modern IT delivery in regulated environments? Do you thrive in a role where you combine deep compliance expertise with hands-on support of agile product and platform teams?

If so, now is your chance to join Ascendis Pharma as our new Associate Director, IT Compliance.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a passionate Associate Director, IT Compliance to join our team. As a key member of the Ascendis Pharma team, you will act as a trusted compliance advisor supporting GxP-regulated IT product and platform teams. We believe that critical thinking and a strong quality mindset are more important than excessive documentation, and we continuously challenge ourselves to apply the principle of "less is more".

This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will be joining the IT Compliance competency team, and report directly to Henrik Aagaard Linnemann, Global Head of Digitalization who is based in Hellerup. You will also be based in Hellerup. Together with the team you will have the opportunity to influence how compliance is implemented in a modern digital organization where established practices are continuously challenged and improved.

Your key responsibilities will be:

• Support IT product and platform teams operating in GxP-regulated environments.
• Provide compliance consultancy across relevant disciplines within IT compliance, quality, validation, testing, and regulatory requirements.
• Support quarterly and semi-annual SOX control activities together with a compliance team colleague.
• Contribute to the continuous maintenance and improvement of the IT Quality Management System (IT QMS).
• Monitor regulatory developments and help ensure relevant changes are reflected in IT governance procedures.
• Support implementation of continuous compliance principles, shift-left testing practices, and agile methodologies.
• Advise stakeholders on relevant regulatory requirements including GxP, data privacy, SOX, NIS2, and the EU AI Act.
• Develop and deliver training and compliance education to colleagues across Global IT.
• Act as a role model for quality, critical thinking, and risk-based decision making.

Qualifications and Skills:

You hold a relevant academic degree - preferably a master’s degree and have solid IT understanding. You have experience working in regulated pharmaceutical environments and brings a strong combination of regulatory knowledge, practical validation experience

Furthermore, you have:

• GxP-regulated environments, ideally with 10+ years of experience.
• SOX controls and compliance processes.
• Pharmaceutical IT compliance and computer system validation activities.
• Validation planning, testing, test execution, and quality assurance activities.
• Regulatory frameworks such as 21 CFR Part 11, EudraLex Volume 4 Annex 11, the draft Annex 22, EU AI Act, NIS2, SOX and European data privacy regulations.
• GAMP 5 and the risk-based approach described in Appendix M.
• Teaching, training, and coaching colleagues in compliance-related disciplines.
• Supporting agile delivery teams while maintaining appropriate regulatory oversight.

Key competencies:

You are a strong team player, analytical, and have a can-do attitude.

You possess a strong technical understanding and can communicate effectively with highly skilled IT professionals. You can translate regulatory requirements into practical guidance that supports efficient and compliant delivery.

You understand current regulatory expectations from both FDA and EMA and maintain an up-to-date perspective on evolving compliance requirements.

As a person, you are self-organizing and capable of managing priorities and ongoing activities independently. You enjoy sharing knowledge and helping colleagues grow and mature through coaching and guidance. You naturally act as a role model, demonstrating a quality mindset, sound judgement, and strong critical thinking skills.

You work in a pragmatic and collaborative manner, adapting your approach to the needs of stakeholders while maintaining focus on quality and compliance. Furthermore, you thrive in environments where continuous improvement, innovation, and practical problem solving are valued.

Travel:5-10 days per year.

Office: Tuborg Boulevard 12, 2900 Hellerup

Apply now.

We evaluate applications when received, so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.

To ensure your application is reviewed, please submit it through the specified platform - applications sent by email or other channels will not be evaluated.

For more details about the position or the company, please contact Henrik Aagaard Linnemann, [email protected]

You can learn more about Ascendis by visiting our websitewww.ascendispharma.com

Applications must be submitted in English and will be treated confidentially.

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs, your ownership of these candidates will not be acknowledged.