QA Specialist, QA for QC

8 hours ago

Gentofte Kommune, Denmark Ascendis Pharma AS Full time

Ascendis Pharma A/S , a visionary and ambitious company, offers you an opportunity to become a participant in the further establishment and effective operation of the QA Commercial department. You are offered a position with potential to grow your professional and personal skills and to be part of the handling of new products and new markets. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance our exciting product pipeline.

As QA Specialist, QA for QC , you will be part of a dynamic and competent team contributing to the development of the QA for QC capabilities and get the opportunity to contribute with your knowledge and experience.

Your role will specifically focus on QA oversight of our outsourced analytical testing for starting materials, intermediates, drug substances and drug products. You will support and conduct review and approval of analytical documentation, relevant quality system records such as deviations, change controls and CAPAs, and other operational related documentation.

Moreover, you will contribute actively in upgrades of quality systems and SOPs, launch activities, quality management reviews, etc. Finally, you will work to ensure continuous good relations and alignment with CMOs worldwide and stay updated with insights into their methods and processes. Your role may expand to cover CMO oversight activities in general.

Ascendis Pharma is a virtual biotech company that works with CROs and CMOs worldwide. Therefore, it is crucial you appreciate the elements necessary to provide excellent external supplier management and oversight, as well as support the organization in establishing/maintaining relevant quality processes.

Main areas of responsibility:

  • Review and approval of analytical documentation from CMOs and/or testing laboratories, including but not limited to laboratory records, deviations, laboratory investigations, OOS/OOT/OOE, changes, CAPAs, analytical method validation and stability protocols and reports.
  • Support commercial Ascendis Pharma quality management review process, annual product quality reviews, and other projects that the department is involved in.
  • Participate as needed in inspections and internal and external audits in Ascendis Pharma.
  • Communication with key personnel at CMOs, including face-to-face and online meetings.
  • Keep up to date with changes in relevant guidelines and regulatory requirements and ensure cGMP at Ascendis and CMOs.

You have minimum 5-10 years’ experience from Quality Assurance and/or Quality Control within the life science industry. Preferably, you have solid experience with commercial operations, participation in various projects as a QA representative. You have good experience with regulatory expectations and guidelines for analytical methods. Furthermore, you are competent within stakeholder management, including oversight of outsourced activities, and have a good business understanding.

You have a master’s degree preferably in pharmacy or other relevant natural sciences. You are proficient in English at a professional level, both written and spoken, and you master MS Office.

You are meticulous with a high level of attention to details. You are clear and persistent in your expectations and requirements to quality, while at the same time being pragmatic and flexible in your approach. You are self-motivated and able to work independently and finally you can communicate clearly, both internally and externally towards CMOs and other stakeholders. You ensure progress and take responsibility in agreed tasks and matters.

Travelling : Approx. 5-15 days per year.

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

Hiring manager is QA Director, Jan Jakobsgaard. However, for more details about the job or the company, please contact QA Senior Manager, Christian Borch Hansen, M +45 40427787. Applications must be submitted in English and are treated confidentially. All applications will be evaluated early February 2025.

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