Associate Director, GCP Quality & Audit Lead

Ascendis Pharma; Gentofte Kommune; On-site; DKK 1,000,000 - 1,300,000; Full time

Job summary

Ascendis Pharma seeks an Associate Director, GCP Quality to lead and perform GCP audits across global clinical development programs. Based at our Hellerup HQ, you will join a 4-person GCP Quality team and report to the Senior Director & QP in Denmark.

You will review audit data, collaborate with cross-functional teams, drive CAPA processes, and support regulatory inspections with expert GCP guidance. Travel 30–50 days/year to sites and partners.

Qualifications

• Master's degree in life sciences and 8+ years of GCP quality experience.
• Proficient in English (written and spoken) at a professional level.
• Lead GCP auditor of clinical trial sites and service providers.
• Lead auditor certification.

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 causes and trends.
• 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.

Skills

Lead GCP Auditor

GCP Quality

English Proficiency

Regulatory Knowledge

Auditing Certification

Education

Master's degree in Life Sciences

Job description

Ascendis Pharma seeks an Associate Director, GCP Quality to lead and perform GCP audits across global clinical development programs. Based at our Hellerup HQ, you will join a 4-person GCP Quality team and report to the Senior Director & QP in Denmark.

You will review audit data, collaborate with cross-functional teams, drive CAPA processes, and support regulatory inspections with expert GCP guidance. Travel 30–50 days/year to sites and partners.