Pharmaceutical Supplier Quality Expert

14 hours ago


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

About Sobi

Sobi is a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. We are dedicated to providing reliable access to innovative medicines in areas such as haematology, immunology, and specialty care.

We live by our core values: Care, Ambition, Urgency, Ownership, and Partnership. These values guide our approach to creating solutions that meet the needs of those affected by rare diseases while driving sustainable growth.

The Role

We are seeking an experienced Pharmaceutical Supplier Quality Expert to join our team. As a key member of our quality assurance function, you will be responsible for ensuring compliance with GMP & GDP regulations and Sobi's quality system. You will serve as the primary contact point for all quality-related activities with external suppliers.

Your Key Responsibilities

  • Serve as the primary contact for all quality-related activities with external suppliers.
  • Ensure compliance with GMP & GDP regulations and Sobi's Quality System.
  • Oversee product release, supplier qualifications, and quality technical agreements.
  • Implement and maintain quality risk assessments and KPIs.
  • Manage quality issues, audits, and change requests.
  • Lead quality initiatives and act as a quality representative in projects.

Qualifications

  • Degree in pharmacy, medicine, veterinary medicine, chemistry, technology, or natural science, including courses in inorganic, organic, analytical, physical, and medical chemistry, biochemistry, physiology, galenic pharmacology/pharmaceutical technology, pharmacology, and toxicology.
  • More than 10 years of experience within pharmaceutical, biotech products. More than 5 years of experience in QA operation or external quality including supplier quality management (GMP, GDP).
  • In-depth understanding of GMP requirements of FDA; EMEA, or other Health Authorities.
  • Strong understanding of risk assessment and risk management fundamentals/tools.
  • Excellent verbal and written communication skills.
  • Fluently spoken and written English.


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