Associate Director, GCP Quality

Ascendis Pharma A/S; Gentofte Kommune; À distance; DKK 1 200 000 - 1 800 000; Plein temps

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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

Connaissances

GCP quality

Auditing

Regulatory knowledge

English communication

Formation

Master's degree in life sciences

Outils

Lead auditor certification

Description du poste

Are you passionate about driving GCP compliance and quality excellence across global clinical development programs?

If so, now is your chance to join Ascendis Pharma as our new Associate Director, GCP Quality.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients' lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a passionate Associate Director, GCP Quality to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in performing GCP audits. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross‑functional, global teams working together to achieve extraordinary results.

You will be joining the GCP Quality team consisting of 4 colleagues, and report directly to Lone Neergaard Pedersen, Senior Director & QP, Head of GCP Quality who is based in Hellerup. You will be based in Hellerup.

Your key responsibilities will be:

• 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
• 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

Qualifications and Skills:

You hold a relevant academic degree – preferably a master’s degree in life sciences – and at least 8 years of experience within GCP quality from the pharmaceutical industry. You are proficient in English at a professional level, both written and spoken.

you have:

• Demonstrated experience as a lead GCP auditor of clinical trial sites and service providers
• Strong working knowledge of drug development, clinical operations, regulatory authorities, and/or quality assurance
• Demonstrated proficiency in English at a professional level, both written and spoken
• Obtained a lead auditor certification

Key competencies:

You are a strong team player with excellent stakeholder management skills and a proactive, solution‑oriented mindset. You thrive in a dynamic environment and can balance business needs with quality and compliance requirements.

You are highly structured, analytical, and able to simplify complex issues into clear recommendations and actions. You communicate confidently and effectively with stakeholders across a global organization and build strong relationships based on trust, integrity, and collaboration.

Travel: 30-50 days per year.

Office: Tuborg Boulevard 12, 2900 Hellerup, Denmark