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Ascendis Pharma, a global biopharmaceutical company, is seeking a Senior Professional to join its QA Commercial Drug Product & Finished Goods team in Hellerup, Denmark. The role focuses on quality assurance and regulatory compliance for commercial drug products and finished goods, with responsibility for batch documentation review, deviation management, and CMO (contract manufacturing organization) collaboration.
Key responsibilities include reviewing batch documentation for drug products and finished goods, evaluating deviations, CAPAs (Corrective and Preventive Actions), and other quality-related documentation. You will collaborate extensively with internal teams and external CMO partners who produce drug products and perform secondary packaging. The role involves supporting departmental planning and oversight of key tasks such as product release, SOP updates, and Annual Product Quality Reviews (APQR).
You will be part of a 6-person QA Commercial team reporting directly to the Senior Director of QA Commercial, based at the company's headquarters in Hellerup. The position requires working across all aspects of quality oversight related to CMO production, handling a broad range of tasks and assignments in a fast-paced, dynamic environment.
Required qualifications include a Master's degree in natural science (preferably MSc. Pharmacy) and 2–5 years of pharmaceutical industry experience. Essential competencies include GMP (Good Manufacturing Practice) knowledge, strong quality mindset with critical thinking and attention to detail, cooperative stakeholder management, CMO collaboration experience, and ability to thrive in multicultural, international settings. You should be analytical, a strong team player with a can-do attitude, proficient in English (written and spoken), and skilled in MS Office. The role involves minimal travel (5–10 days annually).
