QA Manager (Specialist)

Are you passionate about QA and about working on getting products to the market that make a difference in the lives of people with rare endocrine disease? Do you have experience within QA for commercial products?

If so, now is your chance to join Ascendis Pharma as our new QA Manager (Specialist) in QA Commercial Drug Product & Finished Goods

Ascendis Pharma is a fast-growing global biopharmaceutical company committed to making a meaningful difference in patient’s lives. We have locations in Denmark, Germany, the United States, the UK, Italy, Spain, and France.

Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs.

Today, we are advancing programs in Endocrinology Rare Disease and Oncology. In addition, we collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.

We are seeking a passionate QA Manager (Specialist) to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in making sure we get products to the market and securing quality oversight of sterile production of drug product and packaging operations for commercial products performed at our Contract Manufacturing Organizations (CMOs). 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 QA commercial Drug Product & Finished Goods team responsible for release of Drug Product & Finished Goods produced at our CMOs as well as quality oversight of the CMOs. The team is part of the QA Commercial Operations Department based in our Headquarters in Hellerup, Denmark.

Your key responsibilities will be:

• Contribute to the release of products to the markets and to our partners e.g. review of batch documentation, analysis documentation, handling of deviations, CAPAs and change controls
• Quality oversight of CMOs e.g. review and approval of documentation (CPVs, stability studies, QMRs, quality agreements etc.)
• Close collaboration with CMOs and our internal stakeholders to handle daily challenges and improvements
• Keep up to date with changes in relevant product guidelines and regulatory requirements and ensure cGMP at Ascendis and CMOs
• Continuously optimize our work processes and the way we execute quality oversight

Qualifications and Skills:

You hold a Master’s degree in Natural Science (preferably MSc. Pharm) and have 5-10 years of experience within pharma QA or manufacturing.

Furthermore, you have:

• Solid GMP experience and understanding
• Experience with sterile production and packaging operations
• Experience with CMO collaboration
• Experience with audits/inspections
• Qualifications to become QP is a plus

Key competencies:

You are a strong team player, analytical, and have a can-do attitude.

You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.  

To succeed in this role, we also expect you to be

• Critically thinking, pragmatic and yet with attention to the necessary details
• Clear and persistent in your communication, expectations, and requirements to quality
• Cooperative and striving for smooth cooperation with many stakeholders from different cultures

Travel: 5-20days per year.

Office: Hellerup, Denmark 

Apply now.

Applications will be evaluated when received, so please apply as soon as possible.

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

For more details about the position or the company, please contact QA Director, Nina Bornhøft Nielsen, M +45 30191902.

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

Applications submitted via email or other channels will not be reviewed.