Reporting to the Head Quality, International Organization, the Director of Quality Assurance Disposition will be responsible for providing QA oversight and support of Moderna’s international organization’s product disposition for clinical and commercial product manufactured at contract manufacturing organizations (CMO) and tested at contract laboratory organizations (CLO). This role will act as Qualified Person (QP) in accordance with EU GMP and manage other QPs to provide final certification/release along with ensuring overall maintenance of site quality management system (QMS) to support release of product for EU/EEA markets as well as wholesale distribution to EU countries. The Director of QA Disposition will ensure clinical and commercial drug substance and drug product as well as labeled and packaged product complies with cGMP, international regulatory requirements, and internal policies, procedures and specifications. This leadership role located in Basal, Switzerland will lead Quality improvement initiatives and ensure robust processes and systems are implemented across Moderna’s international operations. The Director Quality Assurance Disposition will collaborate with Manufacturing, QC, QA Operations, QA Systems and Compliance, Regulatory Affairs and Supply Chain to ensure Moderna’s products are dispositioned on time to meet defined turnaround times to meet supply and customer requirements and manage Qualified Persons (QPs) to support release to EU countries. The incumbent will be an integral partner to Moderna’s innovative technology platform as we continue to integrate automation and digital technology into everything we do.
Switzerland Manager and Executive Manufacturing and Logistics Quality Assurance Moderna