Associate Director, GCP Quality

About the role

Ascendis Pharma is seeking an Associate Director to lead GCP quality activities across its global clinical development programs. Based in Hellerup, you will join a small, dedicated GCP Quality team and report to the Senior Director & QP, Head of GCP Quality.

Key responsibilities

• Plan, perform and report internal, site and service provider GCP audits.
• Analyse audit, inspection, deviation and CAPA data to identify trends and root causes.
• Review and approve quality intakes, serious breach reports, deviations and CAPAs.
• Provide expert GCP compliance advice and support regulatory inspection planning and follow‑up.
• Collaborate with subject‑matter experts to formulate responses to inspection findings and drive quality initiatives.

Required profile

• Master’s degree in life sciences or related field.
• Minimum 8 years of GCP quality experience in the pharmaceutical industry.
• Professional proficiency in English, both written and spoken.
• Lead auditor certification and proven experience auditing clinical trial sites and service providers.

Required skills

• Strong knowledge of drug development, clinical operations and regulatory requirements.
• Excellent stakeholder management and analytical abilities.
• Ability to simplify complex issues into clear recommendations.