Regulatory Compliance Manager

6 days ago


Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time

At Sobi, we are committed to transforming the lives of people with rare and debilitating diseases. We believe that quality is at the heart of everything we do, and as a Quality Supplier Manager, you will play a critical role in ensuring compliance with GMP & GDP regulations.

The ideal candidate will have a deep understanding of GMP requirements, including FDA, EMEA, or other Health Authorities' regulations. You will be responsible for overseeing product release, supplier qualifications, and quality technical agreements, while implementing and maintaining quality risk assessments and KPIs.

In this role, you will serve as the primary contact for all quality-related activities with external suppliers, ensuring compliance with our Quality System. You will also lead quality initiatives, manage quality issues, audits, and change requests, and act as a quality representative in projects.

We are looking for a collaborative and results-driven individual who can influence external suppliers in a cross-functional environment. If you have a strong understanding of risk assessment and risk management fundamentals/tools, excellent verbal and written communication skills, and fluently spoken and written English, we encourage you to apply.



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