External Quality Operation Manager; GMP

Job Description

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.

• 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), and meet relevant CGMP regulatory requirements
• Support release products to Markets
• Support the External Service Provider (CMO) qualification
• Ensure Quality Technical Agreement (QTA) is established appropriately and clearly defines roles & responsibilities between Sobi and the External Supplier
• Ensure implementation and maintenance of Quality Risk Assessment and KPIs on quality external activities. Guide defining & monitoring remediation plans to ensure that issues are suitably addressed and 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 and assess the performance of the product and the process per Sobi requirements
• Manage & approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirements
• Ensure that change requests 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 requirements and the QTA
• Lead to define strategy of implementation and monitoring of key quality transformation initiatives and align with all process stakeholders outside of the Quality organization
• Lead or act as Quality representative in projects related to CMO such as Tech Transfer, Launch
• Assess and ensure CMO inspection readiness for Health Authorities (HAs)
• Support HA inspections/audits of Sobi
• Inform the line manager and cross‑functional teams of all critical & major issues and elevate any issues as per Sobi escalation policy
• Ensure good collaboration is maintained within Global Quality Operations and cross‑functionally
• Ensure batch release as required

• High‑level education (university degree or similar) within a relevant area such as pharmaceutical, biotech or life science
• More than 5 years of experience within pharmaceutical or biotech product, with experience in QA operation, production or other relevant area (GMP, GDP)
• More than 1 year of managing external quality oversight of CMOs
• Curriculum is requested for evaluating the batch release qualification requirement
• Fluently spoken and written English

• More than 2 years of working in a global operations environment with English as a main language
• Proven experience of leading quality KPI assessment and improvement at CMOs
• Proven track record with FDA, EMEA or other Health Authorities
• Strong understanding of risk assessment and risk management fundamentals/tools

• Competitive compensation for your work
• Generous time‑off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team‑oriented environment
• Making a positive impact to help ultra‑rare disease patients who are in need of life‑saving treatments

At Sobi, we are dedicated to…