QA Specialist

Ascendis Pharma

Ascendis Pharma

Software Engineering, Quality Assurance
2900 Hellerup, Denmark
Posted on Friday, April 21, 2023

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, 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 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.