Senior PV Quality Manager/Associated Director, GVP Quality

Are you passionate about GVP audits? Do you have a strong quality mindset?

If so, now is your chance to join Ascendis Pharma as our new Senior PV Quality Manager.

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 portfolio. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

• →Plan, perform, and report on GVP audits (internal, affiliate, and vendor/partner) in collaboration with GVP colleagues.
• →Review and analyze audit, inspection, deviation, and CAPA data to identify root causes, trends, and areas of exposure.
• →Prepare compliance metrics, conduct non-compliance investigations, and support regulatory inspections, including planning, execution, and follow-up.
• →Provide expert advice on GVP compliance and regulatory matters, acting as Global quality partner to PV Operations (US/DK) and the EU QPPV.
• →Author and maintain GVP Quality procedures and support implementation of new or updated GVP requirements.
• →Support PV vendor oversight, including vendor qualification, quality agreements and contracts, and proactively monitor PV Quality systems to identify risks.
• →Collaborate with SMEs on inspection responses and quality development initiatives within the GVP area.

All applications must be submitted in English and are treated confidentially.

A note to recruiters: 

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.