Head of Clinical Quality Assurance

22 hours ago


Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time
Head of Clinical Quality Assurance Job Description

We are seeking an experienced Head of Clinical Quality Assurance to lead our quality assurance function at Sobi. As a key member of our team, you will play a vital role in ensuring the quality and compliance of our Investigational Medicinal Products (IMPs).

In this role, you will be responsible for leading supplier management teams, overseeing manufacturing quality, and ensuring adherence to GMP & GDP regulations. A strong understanding of GMP & GDP requirements in support of IMP studies is essential, as well as experience working with quality aspects of medicinal products in clinical trials.

  • Key Responsibilities:
  • Work cross-functionally with R&D, GCP/GVP QA, QA Supplier Managers and Product Quality Leads to address and escalate IMP quality issues.
  • Support supplier audits and ensure readiness for Health Authority GMP inspections.


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