Global External Quality Ops Lead

Sobi - Swedish Orphan Biovitrum AB (publ); Stockholms kommun; Hybrid; SEK 900,000 - 1,350,000; Full time

Benefits offered by this job

Competitive compensation

Flexible workplace

Diversity and Inclusion

Professional growth opportunities

Job summary

Sobi is seeking an External Quality Operations Manager to oversee quality oversight of external manufacturing partners and ensure reliable supply of high‑quality medicines. This hybrid role works with CMOs and internal teams in a fast‑moving global environment.

The EQOM will strengthen partnerships, drive continuous improvement, and ensure Quality systems, QTA, and regulatory readiness across the organization. Fluency in English and GMP/GDP knowledge are required.

Qualifications

• High level education in pharmaceutical, biotech or life science.
• More than 5 years of experience in pharma/biotech QA operations.
• More than 1 year of external quality oversight of CMOs.
• Fluently spoken and written English.

Responsibilities

• Act as EQOM and single point of contact for quality activities at CMOs.
• Ensure CGMP regulatory compliance and proper QTA between Sobi and CMOs.
• Support product release as QP Delegate when required.
• Lead Quality transformation initiatives with cross-functional stakeholders.
• Prepare for HA inspections and support HA audits.

Skills

Quality management

Stakeholder collaboration

GMP/GDP knowledge

Education

Bachelor’s degree in pharmaceutical or life science

Tools

QMS

Quality systems

Job description

Sobi is seeking an External Quality Operations Manager to oversee quality oversight of external manufacturing partners and ensure reliable supply of high‑quality medicines. This hybrid role works with CMOs and internal teams in a fast‑moving global environment.

The EQOM will strengthen partnerships, drive continuous improvement, and ensure Quality systems, QTA, and regulatory readiness across the organization. Fluency in English and GMP/GDP knowledge are required.