QA Specialist, QA Commercial Drug Substance

QA Specialist, QA Commercial Drug Substance Ascendis Pharma Hellerup, Denmark Description 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. 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; Strong analytical skills, a collaborative mindset, and a can-do attitude; Cultural understanding; Experience with audits/inspections; A critical and pragmatic mindset and yet with attention to the necessary details; Clear and persistent communication skills, particular regarding 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 QA specialist requires experience with and knowledge of US and EU GMP regulations and requirements. Furthermore, you should be proficient in English at a professional level, both written and spoken, and you master MS Office. Apply Now