External Quality Operations Manager (Hybrid)

About the role

Sobi is looking for an External Quality Operations Manager (EQOM) to oversee quality of external manufacturing partners and support the reliable supply of high-quality medicines. As the main quality interface with Contract Manufacturing Organizations (CMOs), you will work closely with internal stakeholders in a fast-moving, global environment. This is a hybrid role based in the Global Hub in Basel, Switzerland or the headquarters in Stockholm, Sweden, reporting to the Associate Director, External Quality Operations.

Key responsibilities

• Act as single point of contact for all quality-related activities at each CMO and ensure handling, manufacturing and distribution comply with Sobi's quality system, the Quality Technical Agreement and CGMP requirements.
• Support product release as QP Delegate when required, and support CMO qualification.
• Ensure the Quality Technical Agreement is properly established and defines roles and responsibilities, and maintain quality risk assessments and KPIs.
• Guide remediation plans, drive quality improvements, and assess product and process performance (APQR/PQRs, stability reports).
• Manage deviations, CAPA and complaints, and approve or manage change requests in line with the QTA.
• Lead or act as quality representative on projects such as tech transfer and launch, and support CMO readiness for health authority inspections.
• Lead quality transformation initiatives and coordinate with Global Quality Operations and cross-functional teams.
• Escalate critical issues to the line manager and follow the escalation policy.

Required profile

• University degree or similar in pharmaceutical, biotech or life sciences.
• More than 5 years of experience in pharmaceutical or biotech product QA, production or a related GMP/GDP area.
• More than 1 year managing external quality oversight of CMOs; curriculum requested for batch release qualification.
• Fluent spoken and written English; preferred: more than 2 years in a global environment with English as main language.
• Proven experience leading quality KPI assessment and improvement at CMOs, and a track record with FDA, EMEA or other health authorities.

Required skills

• Strong understanding of risk assessment and risk management fundamentals and tools.
• Ability to build relationships with external partners and work cross-functionally.

The role is described as hands-on, combining operational responsibility with continuous improvement. Applications should be sent through the online application form with a resume in English.