QA Manager, Starting materials and intermediates
Ascendis Pharma, Denmark

Ascendis Pharma A/S, a visionary and ambitious company, offers you an opportunity to become a participant in the further establishment and effective running of QA Commercial Operations. You are offered a position with potential to grow your professional and personal skills and to be part of the introduction of new products to be marketed.

As QA Manager, Starting materials and intermediates you will be a part of the QA Drug Substance team in the QA Commercial Operations department, with responsibility for oversight of starting materials and intermediates for commercial products. We have a close collaboration with our Contract Manufacturing Organizations (CMOs) and SMEs internally at Ascendis Pharma.

Your key responsibilities:

• Review of documentation from CMOs, including batch records, deviations, changes, CAPAs, stability studies, etc.
• Communication with key personnel at CMOs, including face-to-face meetings and teleconferences
• Participate in CMO evaluations, 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 take responsibility in agreed tasks and matters
• Continuously optimize our work processes and the way we execute quality oversight
• Minimum 5 years of experience and a master’s degree
• Experience with chemical production
• Experience with QC/analysis
• Working with CMOs
• 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
• Ambitious and able to see the benefits in going the extra mile

The preferred candidate:

If you have some of the following experiences, knowledges and personal qualities, you might be our ideal and preferred candidate:

The position as QA Manager requires experience with and knowledge of US and EU GMP regulations and requirements. Furthermore, you should beproficient in English and Danish at a professional level, both written and spoken, and you master MS Office.

At Ascendis Pharma, you will be part of a stimulating, informal, and innovative working environment, where you will interact with very skilled colleagues and partners to deliver on Ascendis’ ambitious corporate goals. You will be part of an expanding QA-organization overseeing development, clinical, and commercial activities.

Travelling: 5-10 days/year, flexibility/variation is possible.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbour, the canals and the sea.

For more details about the job or the company, please contact QA Manager, Christian Borch Hansen, M +45 40 42 77 87 or QA Director, Søren Mørch, M +45 23 25 01 23. All applications must be submitted in English and are treated confidentially.

Job Rewards and Benefits