Global External Quality Operations Manager

Sobi; Stockholms kommun; Hybrid; SEK 1,100,000 - 1,400,000; Full time

Benefits offered by this job

Competitive compensation

Diversity and Inclusion

Flexible workplace

Job summary

Sobi is seeking an External Quality Operation Manager (EQOM) to provide robust quality oversight of external manufacturing partners and ensure reliable supply of high‑quality medicines. You will interface with CMOs and collaborate across Sobi in a fast‑moving, global environment.

The role is hands‑on with a focus on compliance, continuous improvement, and risk management. It is a hybrid position based in Basel or Stockholm, reporting to the Associate Director, External Quality Operations.

Qualifications

• High level education in pharmaceutical, biotech or life science
• More than 5 years in pharma/biotech QA/operation
• +1 year managing external QA oversight of CMOs
• Fluently spoken and written English
• Experience in global operations with English as main language
• Proven track record with Health Authorities inspection readiness

Responsibilities

• Act as single point of contact for quality activities at CMOs
• Ensure CGMP/GDP compliance and proper QTA definitions
• Support product release as QP Delegate when needed
• Oversee CMO qualification and qualification activities
• Maintain Quality KPIs and risk assessments for external activities
• Review product and process data (APQR/PQRs, stability) per QTA
• Manage deviations, CAPAs and complaints
• Lead quality transformations with cross-functional teams
• Prepare for Health Authority inspections and internal readiness
• Collaborate with Global Quality Operations cross-functionally

Skills

QA oversight

English proficiency

Regulatory knowledge

Stakeholder collaboration

Quality improvement

Education

University degree in pharmaceutical/life science

Tools

Quality Management Systems

Job description

Sobi is seeking an External Quality Operation Manager (EQOM) to provide robust quality oversight of external manufacturing partners and ensure reliable supply of high‑quality medicines. You will interface with CMOs and collaborate across Sobi in a fast‑moving, global environment.

The role is hands‑on with a focus on compliance, continuous improvement, and risk management. It is a hybrid position based in Basel or Stockholm, reporting to the Associate Director, External Quality Operations.