Quality Oversight Director for External Partners

6 days ago


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

Job Summary:

The Quality Supplier Manager is responsible for managing the quality interface and cross-functional relationships with Sobi stakeholders. This position requires strong leadership and communication skills, as well as an in-depth understanding of GMP requirements.

Responsibilities:

  • 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 of at least 160 university credits in pharmacy, medicine, veterinary medicine, chemistry, technology, or natural science.
  • More than 10 years of experience within pharmaceutical, biotech products, and QA operations or external quality including supplier quality management.
  • 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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