Quality Assurance Manager

3 days ago


Stockholm, Stockholm, Sweden TN Sweden Full time
Job Description

We are seeking an experienced Senior Clinical Quality Manager to join our team in Stockholm, Sweden or Basel, Switzerland. In this role, you will be responsible for ensuring the quality and compliance of Investigational Medicinal Products (IMPs) across various markets.

Key Qualifications:

  • Bachelor's degree or equivalent education/degree in life sciences.
  • Solid understanding of GMP, GDP, and GCP requirements in support of IMP studies.
  • Minimum 10 years of experience in pharmaceutical, biotech, or related fields.
  • Relevant experience from working with quality aspects of medicinal products in clinical trials, especially batch allocation and supply to clinical trials.
  • Strong working knowledge of US and European regulations, with emphasis on Annex 13, and preferably other regions such as APAC and LATAM.
  • Strong understanding of risk assessment and risk management fundamentals/tools.
  • Fluently spoken and written English.

About Our Company

We are a specialized international biopharmaceutical company dedicated to transforming the lives of people with rare and debilitating diseases. Our commitment to innovation, reliability, and accessibility sets us apart in the industry.



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