Strategic IT Compliance Lead — GxP, SOX & RegTech

Ascendis Pharma; Hellerup; Vor Ort; DKK 1.100.000 - 1.500.000; Vollzeit

Zusammenfassung

Ascendis Pharma is seeking an Associate Director, IT Compliance to join our team in Hellerup, Denmark. You will advise and support IT product teams operating in GxP-regulated environments, aligning validation, testing, and regulatory requirements with agile delivery practices.

You will lead SOX control activities, help maintain the IT Quality Management System, and monitor evolving regulations such as EU AI Act and NIS2. Travel 5–10 days/year. Contact [e-mail] for details.

Qualifikationen

• GxP-regulated environments with extensive experience in compliance.
• SOX controls and compliance processes.
• Pharmaceutical IT compliance and computer system validation activities.
• Validation planning, testing, and quality assurance.
• Regulatory frameworks: 21 CFR Part 11, EudraLex Annex 11, Annex 22, EU AI Act, NIS2, SOX, GDPR.
• GAMP 5 and risk-based approaches.
• Teaching, training, and coaching colleagues in compliance.

Aufgaben

• Support IT product and platform teams operating in GxP-regulated environments.
• Provide compliance consultancy across IT disciplines (quality, validation, testing, regulatory).
• Support SOX control activities with the compliance team.
• Contribute to IT QMS maintenance and improvement.
• Monitor regulatory developments and update IT governance procedures.

Kenntnisse

GxP-regulated environments

SOX controls

Regulatory knowledge

Validation activities

Teaching & coaching

Agile delivery support

Strong communication

Ausbildung

Master’s degree in a relevant field

Jobbeschreibung

Ascendis Pharma is seeking an Associate Director, IT Compliance to join our team in Hellerup, Denmark. You will advise and support IT product teams operating in GxP-regulated environments, aligning validation, testing, and regulatory requirements with agile delivery practices.

You will lead SOX control activities, help maintain the IT Quality Management System, and monitor evolving regulations such as EU AI Act and NIS2. Travel 5–10 days/year. Contact [e-mail] for details.