External Quality Operations Manager

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.

As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.

We are committed to an inclusive,sustainable and flexible workplace that fosters growth and development.

As External Quality Operation Manager (EQOM), you will play a central role in ensuring strong quality oversight of external manufacturing partners and supporting the reliable supply of high‑quality medicines. Acting as the main quality interface with Contract Manufacturing Organizations (CMOs), you will collaborate closely with internal stakeholders across Sobi in a fast‑moving, global environment.

This is a hands‑on role combining operational responsibility with continuous improvement. You will help ensure compliance, strengthen partnerships and contribute to developing efficient, future‑ready ways of working.

This position is a Hybrid role, based in our Global Hub in Basel Switzerland or Headquarter in Stockholm, Sweden reporting directly to the Associate Director, External Quality Operations.

Key Responsibilities

• 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, that they meet relevant CGMP regulatory requirement.
• Support the products release by acting as QP Delegate according to delegation documents, when necessary
• 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 is 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 project related to CMO eg Tech Transfer, Launch
• Assess and ensure CMO readiness for Health Authorities (HAs) inspection
• Support HA inspections/audits of Sobi
• Responsible to inform the line manager and cross functional teams of all critical & major issues and elevate any issues as per Sobi escalation policy
• Ensure a good collaboration is maintained within the Global Quality Operations and cross-functionally

You thrive in a dynamic, international environment where priorities evolve and collaboration is essential. You are…