QA Specialist, QA Commercial Drug Substance

About this role

Are you experienced in managing CMO collaborations and building strong relationships with internal and external stakeholders? Do you thrive in a broad QA role where you combine your GMP expertise with a pragmatic and hands-on approach across different quality areas? If so, now is your chance to join Ascendis Pharma as our new QA Specialist in QA Commercial Operations. Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives.

Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs. At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios.

We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets. We are seeking a passionate QA specialist to join our team. You will be a part of the well-functioning QA Drug Substance/QA for QC team in the QA Commercial Operations department, with responsibility for quality oversight of starting materials, intermediates, and Drug Substances for commercial products.

We have a close collaboration with our Contract Manufacturing Organizations (CMOs) and process- and QC SMEs internally at Ascendis Pharma. Your key responsibilities will be: As part of the role, you will work broadly across quality oversight activities and take ownership of a wide range of tasks and responsibilities, including: Take primary responsibility for oversight of one or more CMOs in our supply chains with respect to review and approval of documentation from these CMOs, including upscale activities, PPQ documentation, CPVs, batch documentation, deviations, changes, CAPAs, stability studies, QMRs, quality agreements etc.

Build and maintain strong relationships with key CMO stakeholders, ensuring clear communication and effective collaboration through 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 assume responsibility for agreed tasks and matters Continuously optimize our work processes and the way we execute quality oversight Qualifications and Skills: You hold a relevant academic degree – preferably a master’s degree in pharmacy or equivalent - and 5-10 years of experience within chemical and/or biological GMP production Furthermore, you have: Solid QA experience, preferably including QA for QC, and experience working with CMOs.