GMP Compliance Specialist

1 day ago


Stockholm, Stockholm, Sweden Sobi, Inc Full time

About Sobi, Inc.

Clinical Quality Assurance Manager

We are seeking a highly skilled and experienced Clinical Quality Assurance Manager to join our team at Sobi, Inc. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and leadership.

The Clinical Quality Assurance Manager will be responsible for ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) throughout their lifecycle. This includes developing and implementing quality strategies, managing supplier relationships, and ensuring adherence to regulatory requirements.

Key Responsibilities

  • Develop and implement quality strategies to ensure the quality and compliance of IMPs.
  • Manage supplier relationships to ensure timely delivery of high-quality IMPs.
  • Ensure adherence to regulatory requirements, including GMP & GDP and GCP.
  • 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.

Benefits

  • Emphasis on work/life balance.
  • Collaborative and team-oriented environment.
  • Opportunities for professional growth.
  • Diversity and Inclusion.
  • Competitive compensation for your work.
  • Making a positive impact to help ultra-rare disease patients who are in need of life-saving treatments.


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