Associate Director, IT Compliance

About the role

Ascendis Pharma is seeking an Associate Director, IT Compliance to act as a trusted advisor for GxP‑regulated IT product and platform teams. You will help embed modern compliance practices in a fast‑moving digital environment while supporting agile delivery.

Key responsibilities

• Provide compliance consultancy across IT quality, validation, testing and regulatory requirements for GxP‑regulated environments.
• Support quarterly and semi‑annual SOX control activities and maintain the IT Quality Management System.
• Monitor regulatory developments (e.g., EU AI Act, NIS2) and ensure they are reflected in IT governance procedures.
• Advise stakeholders on GxP, data privacy, SOX, NIS2 and related frameworks, promoting shift‑left testing and continuous compliance.
• Develop and deliver training and education on compliance topics to global IT colleagues.

Required profile

• Master’s degree or equivalent with solid IT understanding.
• 10+ years experience in GxP‑regulated pharmaceutical IT environments.
• Proven experience with SOX controls, computer system validation and risk‑based approaches.
• Strong analytical, critical‑thinking and communication skills, able to translate regulatory requirements into practical guidance.

Required skills

• GxP compliance frameworks (21 CFR Part 11, EudraLex Volume 4 Annex 11, draft Annex 22).
• SOX control processes.
• Regulatory knowledge of EU AI Act, NIS2, European data‑privacy regulations.
• GAMP 5 and risk‑based validation (Appendix M).
• Agile delivery support with shift‑left testing practices.