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 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 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 Masters 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: 5-20 days 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 Bornhft Nielsen M 45 .

You can learn more about Ascendis by visiting our website

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

Required Experience:

Manager