External Quality Operation Manager - Fixed-term maternity cover 12 months
Sobi - North AmericaStockholm, Sweden
Posted March 18, 2026
Full Time
About the Company
Sobi is a global biopharmaceutical company dedicated to rare diseases, committed to creating solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.
Job Description
As External Quality Operation Manager, you will ensure strong quality oversight of external manufacturing partners and support the reliable supply of high-quality medicines. This is a hands-on role combining operational responsibility with continuous improvement.
Requirements
- High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
- More than 5 years of experience within pharmaceutical, biotech product. Experience in QA operation, production or other relevant area (GMP, GDP)
- More than 1 years of managing external quality oversight of CMOs
- Fluently spoken and written English
- More than 2 years of working in global operation environment with English as a main language
- Proven experience of leading Quality KPI assessment and improvement at CMOs
- Proven track record with FDA; EMEA or other Health Authorities
- Strong understanding of risk assessment and risk management fundamentals / tools
Benefits
- Competitive compensation for your work
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Opportunities for professional growth
- Diversity and Inclusion
