QA Specialist – Commercial Drug Substance

About the role

Ascendis Pharma seeks an experienced QA Specialist to oversee quality of starting materials, intermediates and drug substances for commercial products. You will work closely with Contract Manufacturing Organizations (CMOs) and internal quality teams to ensure compliance with GMP standards.

Key responsibilities

• Take primary responsibility for oversight of one or more CMOs, reviewing and approving documentation such as PPQ, batch records, deviations, CAPAs, stability studies and quality agreements.
• Build and maintain strong relationships with CMO stakeholders, conduct meetings, teleconferences and audits, and participate in CMO evaluations and product quality reviews.
• Stay current with US and EU GMP regulations, ensure cGMP compliance at Ascendis and partner CMOs, and drive continuous improvement of quality oversight processes.

Required profile

• Master’s degree in pharmacy or equivalent with 5‑10 years of experience in chemical/biological GMP production.
• Solid QA experience, preferably including QA for QC, and proven work with CMOs.
• Strong analytical mindset, collaborative attitude and ability to communicate expectations clearly.

Required skills

• GMP and cGMP knowledge
• Audit and inspection experience
• Proficiency in English (written and spoken)
• MS Office proficiency