Quality Assurance Specialist

3 days ago


Stockholm, Stockholm, Sweden Sobi, Inc Full time
About the Role

This is a pivotal position where you will ensure quality and compliance of Investigational Medicinal Products (IMPs) through leadership and guidance.

Key Responsibilities:
  • Act as primary quality liaison for external suppliers, organizing inquiries, investigations, and audit follow-ups.
  • Maintain oversight of quality topics for Sobi IMPs across markets.
  • Continuously improve work processes related to quality and compliance of IMPs.
  • Oversee batch record reviews and release for IMPs across US, EU, and RoW clinical trials.
  • Monitor and manage key performance indicators (KPIs) related to IMP supplier quality.
  • Ensure compliance with Quality Agreements and support revisions in collaboration with internal teams.
  • Work cross-functionally with R&D, GCP/GVP QA, QA Supplier Managers and Product Quality Leads to address and escalate IMP quality issues.


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