QA Specialist, QA Commercial Drug Substance

Are you experienced in managing CMO collaborations and building strong relationships with internal and external stakeholders? Do you thrive in a broad QA role where you combine your GMP expertise with a pragmatic and hands-on approach across different quality areas?

If so, now is your chance to join Ascendis Pharma as our new QA Specialist in QA Commercial Operations.

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.

As part of the role, you will work broadly across quality oversight activities and take ownership of a wide range of tasks and responsibilities, including:

• →Take primary responsibility for oversight of one or more CMOs in our supply chains with respect to review and approval of documentation from these CMOs, including upscale activities, PPQ documentation, CPVs, batch documentation, deviations, changes, CAPAs, stability studies, QMRs, quality agreements etc.
• →Build and maintain strong relationships with key CMO stakeholders, ensuring clear communication and effective collaboration through meetings, teleconferences, and audits. Participate in CMO evaluations and product quality reviews
• →Keep up to date with changes in relevant product guidelines and regulatory requirements and ensure cGMP at Ascendis and CMOs
• →Drive and assume responsibility for agreed tasks and matters
• →Continuously optimize our work processes and the way we execute quality oversight

You hold a relevant academic degree – preferably a master’s degree in pharmacy or equivalent - and 5-10 years of experience within chemical and/or biological GMP production

Furthermore, you have: 

• Solid QA experience, preferably including QA for QC, and experience working with CMOs.

• Strong analytical skills, a collaborative mindset, and a can-do attitude  
• Cultural understanding
• Experience with audits/inspections
• A critical and  pragmatic mindset and yet with attention to the necessary details
• Clear and persistent communication skills, particular regarding expectations and requirements to quality
• Cooperative and striving for smooth cooperation with many stakeholders
• Ambitious and able to see the benefits in going the extra mile

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.

For more details about the job or the company, please contact QA Senior Director, Jan Jakobsgaard, M +45 25 66 29 42 leave a message if call is not answered. All applications must be submitted in English and are treated confidentially.

You can learn more about Ascendis by visiting our website www.ascendispharma.com

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.