Quality Assurance Manager for Pharmaceutical Products

2 weeks ago


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

Our Approach

We believe that effective solutions for rare diseases require strong partnerships with patients, partners, and stakeholders across the entire value chain. As a result, we foster sustainable growth while creating opportunities for those caring for patients.

Job Description

The Quality Assurance Manager for Pharmaceutical Products is responsible for ensuring compliance with current GMP & GDP regulations, the Quality Technical Agreement, and Sobi procedures and policies. This role serves as the primary contact for all quality-related activities with external suppliers.

  • 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.


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