Quality Assurance and Compliance Expert

4 hours ago


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

The Clinical Quality Assurance Manager will oversee the quality and compliance of Investigational Medicinal Products (IMPs) through leadership and guidance of supplier management teams.

Key Responsibilities:

  • Ensure quality assurance and compliance across all aspects of IMPs.
  • Develop and implement quality systems and procedures to ensure efficient delivery of high-quality IMPs.
  • Collaborate with cross-functional teams to identify and mitigate quality risks associated with IMPs.
  • Oversee the review and release of batch records for IMPs across various clinical trials.
  • Manage key performance indicators (KPIs) related to IMP supplier quality and implement corrective actions as necessary.
  • Ensure compliance with Quality Agreements and support revisions in collaboration with internal teams.
  • Support supplier audits and ensure readiness for Health Authority GMP inspections.
Requirements

To be successful in this role, you will have:

  • Bachelor's degree or equivalent education/degree in life sciences.
  • Solid understanding of the GMP & GDP and GCP requirements in support of IMP study.
  • Minimum 10 years of experience within pharmaceutical, biotech product.
  • Relevant experience from working with quality aspects of medicinal products in clinical trials, especially batch allocation and supply to clinical trials.
  • Extensive experience in QA operation, production or other relevant area (GMP, GDP).
  • 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.


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