Global GCP Quality Leader - Audits & Compliance

Ascendis Pharma A/S; Gentofte Kommune; Remote; DKK 1.200.000 - 1.800.000; Vollzeit

Zusammenfassung

Ascendis Pharma A/S in Hellerup, Denmark is seeking an Associate Director, GCP Quality to lead audits and ensure GCP compliance across global development programs. You will join a team reporting to the Senior Director & QP, Head of GCP Quality based in Hellerup.

This role emphasizes cross-functional collaboration, regulatory inspections, and driving quality improvements. Travel 30-50 days/year; office address Tuborg Boulevard 12, 2900 Hellerup, Denmark.

Qualifikationen

• Master's degree in life sciences; 8+ years in GCP quality in pharma.
• Proficient in English (written and spoken) at professional level.
• Experience as a lead GCP auditor of sites and vendors.

Aufgaben

• Plan, perform, and report GCP audits of sites and service providers (internal, clinical trial sites and service provider audits)
• Review and analyze audit, inspection, deviation and CAPA data to identify root cause, compliance trends and areas of exposure related to GCP
• Review and approve quality intakes, serious breach reporting, deviations and CAPAs
• Provide expert compliance and regulatory advice within GCP
• Author and maintain procedures owned by GCP Quality
• Support regulatory intelligence monitoring and assessing impact as well as implementation of new/updated GCP regulation
• Lead and support the planning, conduct and follow‑up on regulatory inspections
• Collaborate with subject matter experts to formulate responses to GCP relevant inspection findings
• Drive quality development initiatives within the GCP area
• Perform expert consultation on complex aspects of GCP to projects teams and departments
• Perform the role of quality partner to assigned departments

Kenntnisse

GCP quality

Auditing

Regulatory knowledge

English communication

Ausbildung

Master's degree in life sciences

Tools

Lead auditor certification

Jobbeschreibung

Ascendis Pharma A/S in Hellerup, Denmark is seeking an Associate Director, GCP Quality to lead audits and ensure GCP compliance across global development programs. You will join a team reporting to the Senior Director & QP, Head of GCP Quality based in Hellerup.

This role emphasizes cross-functional collaboration, regulatory inspections, and driving quality improvements. Travel 30-50 days/year; office address Tuborg Boulevard 12, 2900 Hellerup, Denmark.