Join the QA Commercial department in a leading and fast-growing biotech company
Ascendis Pharma, a visionary and ambitious company, offers you an opportunity to become a major participant in the further establishment of the structure and function of QA Commercial department. 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 and support established commercial production.
As QA Manager Product release, you will have highly skilled and passionate colleagues and get the opportunity to be part of the development of the QA Commercial Operations department. This includes QA oversight of our outsourced activities within manufacturing and analytical testing for Drug Substance, Drug Product and Finished product. You will support and conduct review- and approval of i.e., batch documentation, quality systems records such as deviations, change controls and CAPAs and other operational related documentation. Moreover, you contribute actively to the department relevant projects such as continuous upgrades of quality systems SOPs, support launch activities, execution of regular quality management reviews, establish product quality reviews (PQR) for commercial products, IT projects etc. Finally, you work to ensure continuous good relations and alignment with CMOs/CROs worldwide and stay updated with insights into their methods and processes.
Ascendis Pharma is a virtual biotech company that works with CROs and CMOs worldwide. Therefore, it is crucial you understand 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 batch related documentation from CMOs, including but not limited to batch records, deviations, laboratory investigations, OOS, changes, CAPAs, process validation protocols and reports, etc.
- Support commercial Ascendis Pharma Quality Management Review process, the annual product quality reviews and other projects that the department is involved in.
- Participate as needed in inspections and internal and external auditing process in Ascendis Pharma
- Support and review and approve operational documentation such as batch records, validation protocols/reports and Quality agreements
- Communication with key personnel at CMOs, including face-to-face meetings and teleconferences
- Develop and implement GxP improvement projects for systems and procedures including SOPs, policies, forms and tools.
- 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 of Quality Assurance experience within the life science industry. Preferably, you have solid experience with commercial operations, participation in various projects as a QA representative and Quality Systems including deviations, change controls and CAPAs. Furthermore, you are competent within stakeholder management, and have a good business understanding
You have a Master’s Degree preferably in Pharmacy or Natural Science. 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.
Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. 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.
Travelling: Approx. 15-20 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.
All applications must be submitted in English and are treated confidentially.