Quality Management Specialist

2 weeks ago


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

As the Clinical Quality Assurance Manager, you will be responsible for ensuring the quality and compliance of IMPs. This includes acting as the primary quality liaison for external suppliers, organizing inquiries, investigations, and audit follow-ups.

Key Responsibilities
  • 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.


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