Quality Assurance Manager

7 hours ago


Stockholm, Stockholm, Sweden Sobi, Inc Full time
Company Overview

Sobi, Inc is a specialized international biopharmaceutical company dedicated to rare and debilitating diseases. Our mission is to provide reliable access to innovative medicines in the areas of hematology, immunology, and specialty care.

Job Description

The Quality Supplier Manager plays a pivotal role in ensuring compliance with current GMP & GDP regulations, Quality Technical Agreements, and Sobi procedures and policies. This position serves as the primary contact for all quality-related activities with external suppliers.

Key Responsibilities:
  1. Ensure compliance with GMP & GDP regulations and Sobi's Quality System.
  2. Oversee product release, supplier qualifications, and quality technical agreements.
  3. Implement and maintain quality risk assessments and KPIs.
  4. Manage quality issues, audits, and change requests.
  5. Lead quality initiatives and act as a quality representative in projects.


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