Senior QA Manager, QA Commercial Operations
Ascendis Pharma, Denmark

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
As mentioned in job details
Total Vacancies
1 Job
Posted on
Feb 24, 2021
Last Date
Mar 24, 2021
Location(s)

Job Description

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 Senior QA Manager, you will be a part of the QA Drug Substance team in the QA Commercial Operations department, with responsibility for oversight of starting materials, intermediates, and Drug Substance for commercial products. You will also be the key person in QA Commercial Operations for the quality oversight of analytical testing performed on the different manufacturing stages. We have a close collaboration with our Contract Manufacturing Organizations (CMOs) and process- and QC SMEs internally at Ascendis Pharma.

Your key responsibilities:

  • Review and approval 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 and product quality reviews
  • Quality oversight of analytical testing performed on different manufacturing stages and on Drug Substance/Drug Product. This oversight includes QA evaluation of analytical deviations, incl. OOS, and QA approval of analytical method validations.
  • 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 production
  • Experience with QC testing and analytical method validation
  • Knowledge about Analytical Method Validation Guidelines and Regulations
  • Experience with CMO collaboration
  • 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 Senior 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.

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 Director, Søren Mørch, M +45 23 25 01 23. All applications must be submitted in English and are treated confidentially.

Job Specification

Job Rewards and Benefits

Ascendis Pharma

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