Quality Compliance Manager

3 days ago


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

The Clinical Quality Assurance Manager will be responsible for ensuring the quality and compliance of Investigational Medicinal Products (IMPs) through their leadership and guidance of supplier management teams. The successful candidate will have a strong background in quality assurance and a solid understanding of regulatory requirements.

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.

Requirements:

  • 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 a strong commitment to quality and compliance. We are dedicated to making a positive impact on the lives of people with rare diseases.



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