Clinical Quality Assurance Manager

3 days ago


Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time
Job Description:

Sobi is a global biopharmaceutical company dedicated to transforming the lives of people with rare and debilitating diseases. We are seeking an experienced Clinical Quality Assurance Manager to join our team.

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.
  • 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.
  • Ensure compliance with Quality Agreements and support revisions in collaboration with internal teams.
  • Work cross-functionally with R&D, GCP/GVP QA, QA Supplier Managers and Product Quality Leads to address and escalate IMP quality issues.
  • Support supplier audits and ensure readiness for Health Authority GMP inspections.

Qualifications:

  • 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.

About Us:

Sobi is a global company with over 1,800 employees in more than 30 countries. We are committed to the societies where we operate and are dedicated to making a positive impact on the lives of people with rare diseases.



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