QA Manager, PTH Drug Product and Finished Products
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
Aug 20, 2021
Last Date
Sep 20, 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 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, you will be a part of the QA Drug Product/Finished Goods team in the QA Commercial Operations department, with responsibility for oversight of Drug Product manufacturing and packaging activities commercial products.

You will also be a key person in QA Commercial Operations for the quality oversight of serialization and distribution performed by contract manufacturing organizations.

We have a close collaboration with our Contract Manufacturing Organizations (CMOs) and process- and QC SMEs internally at Ascendis Pharma.

Your key responsibilities:

  • Review of documentation from CMOs, including batch records, deviations, changes, CAPAs, stability studies, etc.
  • QA partner in handling shipping and distribution deviations
  • 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 aseptic manufacturing of Drug Product
  • Experience with packaging operations, including serialization, and development and manufacturing of packaging materials
  • Working with CMOs
  • Pragmatic, but 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, knowledge, 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.

Want to apply? Please forward your application and resume Ascendis HR or apply on-line.

All applications must be submitted in English and are treated confidentially.

Job Specification

Job Rewards and Benefits

Ascendis Pharma

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