External Quality Operations Manager

About the role

Sobi is looking for an External Quality Operations Manager (EQOM) to oversee the quality of its external manufacturing partners and support the reliable supply of high-quality medicines. As the main quality interface with Contract Manufacturing Organizations (CMOs), the role combines operational responsibility with continuous improvement in a fast-moving, global environment. It is a hybrid position 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
• Ensure handling, manufacturing and distribution comply with Sobi's quality system, the Quality Technical Agreement and relevant CGMP requirements
• Support product release as QP Delegate when required, and support CMO qualification
• Establish and maintain the Quality Technical Agreement, including roles and responsibilities
• Implement and monitor quality risk assessments, KPIs and remediation plans
• Review product and process data (APQR/PQRs, stability reports) and approve deviations, CAPA and complaints
• Manage change requests and lead quality audits of the CMO
• Lead quality transformation initiatives and act as quality representative on projects such as tech transfer and launch
• Prepare the CMO for health authority inspections and support HA audits of Sobi
• Escalate critical issues and keep Global Quality Operations informed

Required profile

• University degree or similar in pharmaceutical, biotech or life sciences
• More than 5 years of experience in pharmaceutical or biotech products, in QA operations, production or a related GMP/GDP area
• More than 1 year of managing external quality oversight of CMOs
• Fluent spoken and written English
• Desired: more than 2 years in a global environment with English as the main language, proven experience leading quality KPI improvement at CMOs, and a track record with FDA, EMEA or other health authorities

Required skills

• Quality Technical Agreements and CGMP compliance
• Quality risk assessment and risk management
• Batch release qualification (curriculum requested)

Applicants should apply online with their English-language resume; the selection process is ongoing.