Associate Director, GCP Quality

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.

• →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

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.

Furthermore, 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

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.

We evaluate applications when received, so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.   

To ensure your application is reviewed, please submit it through the specified platform - applications sent by email or other channels will not be evaluated. 

We do not allow external search party solicitation.  Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.  If this occurs, your ownership of these candidates will not be acknowledged.