Quality Assurance Strategist

2 days ago


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

Sobi Overview

Sobi is a specialized biopharmaceutical company dedicated to rare diseases. Our mission is to create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

Job Description

This Regulator Compliance position involves overseeing GxP system lifecycle management, managing Quality Data Stewards, evaluating and approving high-level quality concepts and documents, and supporting CSV inspections and internal audits with follow-up activities and remediation guidance. You will have 5 direct reports located in Sweden and Switzerland, and your reports to our Head of Global GxP Compliance & Quality System based in Basel, Switzerland.

Key Responsibilities

  • GxP System Lifecycle Management: Ensure eCompliance by overseeing GxP system lifecycle management, manage Quality Data Stewards, and evaluating and approving high-level quality concepts and documents.
  • Csv Standards and Implementation: Define, maintain, and serve as the single point of contact (SPOC) for corporate Computerized Systems Compliance (Csv) standards across the company.
  • Compliance Verification: Implement Sobi Csv standards and verify compliance through periodic reviews, ensuring adherence to current GxP and company requirements.

Requirements

  • A Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
  • Minimum 10 years of experience in the pharmaceutical industry within Quality systems, manufacturing, R&D, or regulatory affairs, with at least 4 years in a leadership role.
  • Strong understanding of GxP regulations, including FDA, EMA, and other relevant requirements.


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