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Ascendis Pharma, a global biopharmaceutical company, is seeking an Associate Director of IT Compliance to join their Hellerup, Denmark headquarters. You will serve as a trusted compliance advisor supporting GxP-regulated IT product and platform teams, reporting directly to the Global Head of Digitalization.
In this role, you will provide compliance consultancy across IT compliance, quality, validation, testing, and regulatory requirements. Key responsibilities include supporting GxP-regulated IT product and platform teams; providing compliance guidance across relevant disciplines; supporting quarterly and semi-annual SOX control activities; maintaining and improving the IT Quality Management System (IT QMS); monitoring regulatory developments and updating IT governance procedures; supporting implementation of continuous compliance and shift-left testing practices; advising stakeholders on GxP, data privacy, SOX, NIS2, and EU AI Act requirements; developing and delivering compliance training; and acting as a role model for quality and risk-based decision-making.
You will work in a fast-paced, collaborative environment with cross-functional global teams. The company values critical thinking and a strong quality mindset, emphasizing practical, pragmatic approaches over excessive documentation. Travel is estimated at 5–10 days per year.
QUALIFICATIONS AND REQUIREMENTS:
- Master's degree (or relevant academic degree) with solid IT understanding
- 10+ years of experience in GxP-regulated pharmaceutical environments
- Strong knowledge of SOX controls and compliance processes
- Expertise in pharmaceutical IT compliance and computer system validation activities
- Experience with validation planning, testing, test execution, and quality assurance
- Deep understanding of regulatory frameworks: 21 CFR Part 11, EudraLex Volume 4 Annex 11, draft Annex 22, EU AI Act, NIS2, SOX, and European data privacy regulations
- Knowledge of GAMP 5 and risk-based approaches (Appendix M)
- Experience teaching, training, and coaching colleagues in compliance disciplines
- Ability to support agile delivery teams while maintaining regulatory oversight
- Strong team player with analytical mindset and can-do attitude
- Excellent communication skills with highly skilled IT professionals
- Ability to translate regulatory requirements into practical guidance
- Understanding of FDA and EMA regulatory expectations
- Self-organizing with strong priority management and independent work capability
- Demonstrated quality mindset, sound judgment, and critical thinking
- Pragmatic, collaborative approach to problem-solving and continuous improvement
