Associate Director, GCP Quality & Audits (Global)

Ascendis Pharma; Herrested; In loco; DKK 897.000 - 1.345.000; Tempo pieno

Descrizione del lavoro

Ascendis Pharma is seeking an Associate Director, GCP Quality to drive audits and quality excellence across global clinical development programs. Based in Hellerup, you will join a team of four and report to the Senior Director & QP, Head of GCP Quality.

You will lead internal and external audits and collaborate with cross‑functional teams across Europe and the US. You will hold a master’s degree in life sciences (or equivalent) with at least eight years in GCP quality, and demonstrate lead

Competenze

• Requires a relevant academic degree with preference for a master’s in life sciences
• Minimum 8 years of experience in GCP quality within the pharmaceutical industry
• Proficient in English at a professional level, both written and spoken

Mansioni

• Plan, perform, and report GCP audits (internal, sites, and service providers)
• Review audit, inspection, deviation and CAPA data for root-cause analysis and trends
• Provide expert compliance and regulatory advice within GCP
• Lead regulatory inspections and formulate responses to findings
• Develop and maintain GCP quality procedures and support regulatory intelligence monitoring

Conoscenze

Lead GCP auditor

GCP quality

English proficiency

Formazione

Master's degree in life sciences

Descrizione del lavoro

Ascendis Pharma is seeking an Associate Director, GCP Quality to drive audits and quality excellence across global clinical development programs. Based in Hellerup, you will join a team of four and report to the Senior Director & QP, Head of GCP Quality.

You will lead internal and external audits and collaborate with cross‑functional teams across Europe and the US. You will hold a master’s degree in life sciences (or equivalent) with at least eight years in GCP quality, and demonstrate lead