GxP IT Compliance Associate Director

Ascendis Pharma A/S; Gentofte Kommune; Remote; DKK 900,000 - 1,500,000; Full time

Job summary

Ascendis Pharma A/S, a global biopharmaceutical company, seeks an Associate Director, IT Compliance to lead regulatory IT compliance for GxP regulated environments. You will support IT product teams, advise on regulatory requirements, and help maintain IT QMS in a fast-paced setting.

You will collaborate with cross-functional teams across Europe and the US, driving continuous improvement, agile alignment, and risk-based decisions while staying current with FDA/EMA expectations.

Qualifications

• 10+ years of experience in GxP-regulated environments.
• SOX controls and compliance processes.
• Pharmaceutical IT compliance and computer system validation.
• Knowledge of 21 CFR Part 11, EudraLex Annex 11, EU AI Act, NIS2.
• Experience teaching and coaching colleagues.

Responsibilities

• Support IT product and platform teams in GxP-regulated environments.
• Provide compliance consultancy across IT compliance, quality, validation, testing, and regulatory requirements.
• Support quarterly and semi-annual SOX control activities.
• Contribute to IT QMS maintenance and improvement.
• Monitor regulatory developments and update IT governance procedures.
• Support continuous compliance, shift-left testing and agile methodologies.
• Advise on GxP, data privacy, SOX, NIS2 and EU AI Act.
• Develop and deliver training and compliance education.
• Model quality thinking and risk-based decision making.
• Travel 5-10 days per year.

Skills

Regulatory compliance

Analytical thinking

Communication

Stakeholder engagement

Education

Master's degree in a relevant field

Tools

IT QMS

GxP validation tools

Job description

Ascendis Pharma A/S, a global biopharmaceutical company, seeks an Associate Director, IT Compliance to lead regulatory IT compliance for GxP regulated environments. You will support IT product teams, advise on regulatory requirements, and help maintain IT QMS in a fast-paced setting.

You will collaborate with cross-functional teams across Europe and the US, driving continuous improvement, agile alignment, and risk-based decisions while staying current with FDA/EMA expectations.