Senior Clinical Quality Assurance Manager

22 hours ago


Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time
Clinical Quality Assurance Role Overview

Sobi, a global biopharmaceutical company, seeks a skilled Clinical Quality Assurance Manager to oversee the quality and compliance of Investigational Medicinal Products (IMPs). The successful candidate will lead supplier management teams, ensuring adherence to GMP & GDP regulations.

The ideal candidate will have a solid understanding of GMP & GDP requirements in support of IMP studies, along with experience working with quality aspects of medicinal products in clinical trials. Strong leadership skills and excellent critical reasoning, risk-analysis, and problem-solving abilities are essential for success in this role.

  • Main Responsibilities:
  • Lead supplier audits and ensure readiness for Health Authority GMP inspections.
  • 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.


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