External Quality Operation Manager – GMP

🕒 February 28

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Logo of Sobi - Swedish Orphan Biovitrum AB (publ)

Sobi - Swedish Orphan Biovitrum AB (publ)

1001 - 5000 employees

Founded 1991

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Sobi - Swedish Orphan Biovitrum AB (publ) is a global leader in providing innovative treatments for people with rare diseases. Specializing in therapeutic areas such as haematology and immunology, Sobi is committed to improving patient access to medicines for rare and debilitating conditions. With a strong R&D pipeline, the company is actively pursuing new therapies and collaborating globally to transform patient care in areas such as haemophilia and immune thrombocytopenia. Sobi also engages in extensive sustainability and humanitarian aid programs, demonstrating a firm commitment to patient-centric care and societal contributions.

📋 Description

• Join Sobi’s mission to improve the lives of people with rare diseases by ensuring the highest standards of product quality and patient safety • Oversee the quality performance of external manufacturing partners • Act as the primary point of contact for these suppliers • Ensure that every batch produced meets GMP/GDP requirements • Align with Quality Technical Agreements and uphold Sobi’s global quality standards • Drive compliance, collaboration, and continuous improvement to support reliable product supply

🎯 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 • Curriculum is requested for evaluating the batch release qualification requirement • Fluently spoken and written English

🏖️ Benefits

• Competitive compensation for your work • Generous time off policy • Opportunity to broaden your horizons by attending popular conferences • Emphasis on work/life balance • Collaborative and team-oriented environment • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

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