Clinical Quality Assurance Specialist

2 days ago


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

We are seeking a highly skilled Clinical Quality Assurance Specialist to join our team at Sobi. As a Clinical Quality Assurance Specialist, you will play a pivotal role in ensuring the quality and compliance of Investigational Medicinal Products (IMPs) through your leadership and guidance of supplier management teams.

Key Responsibilities:

  • Act as the 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.

Required Skills and Qualifications:

  • Bachelor's degree or equivalent education/degree in life sciences.
  • Have a solid understanding of the GMP & GDP and GCP requirements in support of IMP study.
  • Minimum 10 years of experience within pharmaceutical or biotech product.

Benefits:

  • Emphasis on work/life balance.
  • Collaborative and team-oriented environment.
  • Opportunities for professional growth.
  • Diversity and Inclusion.


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