Senior GCP Quality Lead – Audits & Compliance

Ascendis Pharma; Hellerup; On-site; DKK 1,200,000 - 1,500,000; Full time

Job summary

Ascendis Pharma invites applications for an Associate Director, GCP Quality based in Hellerup, Denmark. You will lead GCP audits across internal sites and service providers, ensuring high-quality compliance and regulatory readiness.

You will report to the Senior Director & QP and collaborate with global teams, guiding CAPA processes and quality improvements in a fast-paced environment.

Qualifications

• Master’s degree in life sciences or equivalent.
• At least 8 years of experience within GCP quality from the pharmaceutical industry.
• Proficient in English at a professional level, both written and spoken.

Responsibilities

• Plan, perform, and report GCP audits (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.
• Lead and conduct regulatory inspections planning, execution and follow-up.
• Collaborate with SMEs to formulate responses to GCP inspection findings.

Skills

Lead GCP auditor

GCP quality

Stakeholder management

English proficiency

Education

Master’s degree in life sciences

Job description

Ascendis Pharma invites applications for an Associate Director, GCP Quality based in Hellerup, Denmark. You will lead GCP audits across internal sites and service providers, ensuring high-quality compliance and regulatory readiness.

You will report to the Senior Director & QP and collaborate with global teams, guiding CAPA processes and quality improvements in a fast-paced environment.