Stockholm, Sweden – Swedish Orphan Biovitrum (Sobi) is hiring an External Quality Operations Manager (EQOM) to oversee GMP/GDP compliance at Contract Manufacturing Organizations (CMOs). This high-impact role ensures the quality and safety of rare disease treatments, offering a competitive salary of $100K–$120K+ depending on experience.
Why Join Sobi?
Sobi is a global biopharmaceutical leader specializing in rare diseases, providing life-changing therapies to patients worldwide. With a dynamic work environment and a commitment to innovation, Sobi fosters career growth in a collaborative, international setting.
Key Responsibilities:
✔ Act as the primary Quality contact for CMOs, ensuring compliance with GMP/GDP regulations
✔ Oversee Quality Technical Agreements (QTAs) and manage deviations, CAPAs, and audits
✔ Support batch release and regulatory inspections (FDA/EMA)
✔ Drive continuous improvement in manufacturing quality and risk management
✔ Lead cross-functional projects, including tech transfers and product launches
Qualifications & Skills:
✅ University degree in Pharma, Biotech, or Life Sciences
✅ 5+ years in pharmaceutical QA, production, or GMP/GDP
✅ 1+ years managing CMO quality oversight
✅ Strong risk assessment & leadership skills
✅ Fluency in English (Swedish not required)
Perks & Benefits:
🔹 Competitive salary ($100K–$120K+)
🔹 International work environment
🔹 Career growth in rare disease therapeutics
🔹 Flexible, agile workplace culture
Apply Now!
If you’re a Quality Operations expert looking to make an impact in rare disease treatments, Sobi wants you!
📍 Location: Stockholm, Sweden (Remote options possible)
📅 Employment Type: Full-time
To view more open positions kindly visit Swedish Orphan Biovitrum Career Page.
Why This Role Matters?
With increasing regulatory scrutiny in pharma, EQOMs play a crucial role in ensuring drug safety and compliance. Sobi’s focus on rare diseases means your work will directly improve patients’ lives.