Regulatory Affairs and Quality Expert

4 days ago


Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time
Regulatory Affairs and Quality Expert - IMP

We are seeking a regulatory affairs and quality expert to join our team at Sobi. As a global company with over 1,800 employees in more than 30 countries, we are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.

Job Description:

As the clinical quality assurance manager, you will be responsible for ensuring the quality and compliance of Investigational Medicinal Products (IMPs) through your leadership and guidance of supplier management teams. You will act as the single point of contact for external suppliers, overseeing manufacturing quality, ensuring adherence to GMP & GDP regulations, and building strong cross-functional relationships with internal stakeholders.

Responsibilities:

  • Organize inquiries, investigations, and audit follow-ups for external suppliers.
  • Maintain oversight of quality topics for Sobi IMPs across markets.
  • Improve work processes related to quality and compliance of IMPs.
  • Review and release batch records for IMPs across US, EU, and RoW clinical trials.
  • Monitor key performance indicators (KPIs) related to IMP supplier quality.
  • Ensure compliance with Quality Agreements and support revisions.
  • Collaborate with internal teams 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.


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