GxP Compliance Manager

11 hours ago


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

Sobi, a global company with over 1,800 employees in more than 30 countries, is seeking an experienced professional to lead and manage the Computer System Validation (CSV) process. As the GxP Compliance Manager, you will be responsible for ensuring e-compliance of GxP systems, overseeing Quality Data Stewards, evaluating and approving high-level quality concepts and documents, and supporting CSV inspections and internal audits.

The ideal candidate will have a strong understanding of GxP regulations, including FDA and EMA requirements, and experience in GxP system lifecycle management, quality data stewardship, and defining/implementing CSV standards. Additionally, they should possess proficiency in performance management, KPIs, and Quality Management Review.

This is a Mid-Senior level position that reports to our Head of Global GxP Compliance & Quality System, based in Basel, Switzerland. If you are a collaborative leader with a keen eye for detail and strong analytical skills, we encourage you to apply.



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