QA Manager/Specialist
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 Specialist/QA Manager, you will be a part of the well-functioning QA Drug Substance team in the QA Commercial Operations department, with responsibility for quality oversight of starting materials, intermediates, and Drug Substance for commercial products. We have a close collaboration with our Contract Manufacturing Organizations (CMOs) and process- and QC SMEs internally at Ascendis Pharma. For this position primary focus will be on CMOs with Chemical Production.

Your key responsibilities:

• Review and approval of documentation from CMOs, including upscale activities, PPQ documentation, CPVs, batch records, deviations, changes, CAPAs, stability studies, QMRs, quality agreements etc.
• Communication with key personnel at CMOs, including face-to-face 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 take responsibility in agreed tasks and matters
• Continuously optimize our work processes and the way we execute quality oversight

The preferred candidate:

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

• Minimum 10 years of experience and a master’s degree
• Experience with chemical GMP production
• QP/delegate QP experience
• Cultural understanding
• Experience with CMO collaboration
• QA experience
• Experience with audits/inspections
• 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 position as QA Specialist/QA Manager requires experience with and knowledge of US and EU GMP regulations and requirements. Furthermore, you should be proficient in English 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: 5-20 days/year.

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

For more details about the job or the company, please contact QA Director, Jan Jakobsgaard, M +45 25 66 29 42. All applications must be submitted in English and are treated confidentially.

Job Rewards and Benefits