• Perform as EQOM to act as Single point of contact for all quality related activities at the Contract Manufacturing Organization (CMO) • Ensure that all aspects of handling, manufacturing, distribution of products are in compliance with Sobi Quality system, the effective Quality Technical Agreement (QTA), that they meet relevant CGMP regulatory requirement • Support release products to Markets • Support the External Service Provider (CMO) Qualification • Ensure Quality Technical Agreement (QTA) be established appropriately and ensure valid QTA clearly defines roles & responsibilities between Sobi and the External Supplier • Ensure implementation and maintaining Quality Risk Assessment and KPIs on Quality External activities • Guide defining & monitoring remediation plans to ensure that issues are suitably addressed • Drive or support improvement opportunities for processes and product Quality performance • Ensure CMO provides product reviews or data (APQR/PQRs, stability reports) as specified in the QTA • Assess the performance of the product and the process as per Sobi requirement • Manage/approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirement • Ensure that Change requests either from CMO or from Sobi are managed according to the QTA and Sobi requirements • Support that Quality Audits of the CMO are performed according to Sobi requirement and the QTA • Lead to define strategy of implementation and monitoring of key Quality transformation initiatives and align with all process stakeholders outside of Quality organization • Lead or act as Quality representative in projects related to CMO eg Tech Transfer, Launch • Assess and ensure CMO for Health Authorities (HAs) inspection readiness • Support HA inspections/audits of Sobi • Responsible to inform the line manager and cross functional teams of all critical & major issues and escalate any issues as per Sobi escalation policy • Ensure a good collaboration is maintained within the Global Quality Operations and cross-functionally • Ensure the batch release as required