External Quality Operation Manager (GMP)

About Join Sobi’s mission to improve the lives of people with rare diseases by ensuring the highest standards of product quality and patient safety. As an External Quality Operations Manager (EQOM), you’ll play a pivotal role in overseeing the quality performance of external manufacturing partners. Acting as the primary point of contact for these suppliers, you’ll ensure that every batch produced meets GMP/GDP requirements, aligns with Quality Technical Agreements, and upholds Sobi’s global quality standards. You’ll be the bridge between Sobi and its external network, driving compliance, collaboration, and continuous improvement to support reliable product supply and Sobi’s fast‑growing global footprint. This role offers the opportunity to work cross‑functionally with Manufacturing, Supply Chain, Technical Operations, and Regulatory Affairs, strengthening Sobi’s commitment to delivering high‑quality medicines to patients worldwide. Key Responsibilities Act as Single point of contact for all quality-related activities at the Contract Manufacturing Organization (CMO) and ensure that all aspects of handling, manufacturing, and distribution of products are in compliance with the Sobi Quality System, the effective Quality Technical Agreement (QTA), and relevant CGMP regulatory requirements. Support release of products to markets and the External Service Provider (CMO) qualification process. Ensure that a valid QTA is established and that it clearly defines roles and responsibilities between Sobi and the external supplier. Implement and maintain Quality Risk Assessment and KPIs for external quality activities. Guide the definition and monitoring of remediation plans to ensure issues are suitably addressed. Drive or support improvement opportunities for processes and product quality performance. Ensure the CMO provides product reviews or data (APQR/PQRs, stability reports) as specified in the QTA and assess the performance of the product and the process according to Sobi requirements. Manage and approve quality issues (deviations, CAPA, and complaints) as per QTA and Sobi requirements. Ensure that change requests from the CMO or from Sobi are managed according to the QTA and Sobi requirements. Support Quality Audits of the CMO performed according to Sobi requirements and the QTA. Lead the strategy of implementation and monitoring of key quality transformation initiatives, aligning with all process stakeholders outside of the Quality organization. Act as Quality representative in projects related to the CMO, e.g., tech transfer, launch. Assess and ensure CMO readiness for Health Authorities (HA) inspections. Support HA inspections/audits of Sobi. Inform the line manager and cross-functional teams of all critical and major issues and escape any issues as per Sobi escalation policy. Ensure good collaboration is maintained within Global Quality Operations and cross-functionally. Ensure batch release as required. #J-18808-Ljbffr