Quality Assurance Strategist

8 hours ago


Stockholm, Stockholm, Sweden Sobi group Full time
About the Company

Sobi is a specialized biopharmaceutical company that has made significant contributions to the field of rare diseases. With a strong focus on quality and compliance, we are seeking a skilled professional to join our team as a GxP e-Compliance Manager.

As a member of our team, you will be responsible for leading and managing CSV initiatives, overseeing quality data stewards, evaluating and approving high-level quality concepts and documents, and supporting CSV inspections and internal audits.

The Role

This exciting opportunity offers an opportunity to leverage your expertise in GxP systems, CSV standards, and quality management. You will work closely with our Head of Global GxP Compliance & Quality System to ensure compliance with GxP regulations and guidelines.

Key Responsibilities

You will be responsible for:

  • Defining and Maintaining CSV Standards: Serve as the single point of contact for corporate CSV standards across the company.
  • Leading CSV Initiatives: Oversee GxP system lifecycle management, manage quality data stewards, evaluate and approve high-level quality concepts and documents, and support CSV inspections and internal audits.
  • Digital Quality Roadmap: Develop and drive the digital quality roadmap and process quality automation across the GxP arena.
Requirements

To succeed in this role, you will need a bachelor's degree in Life Sciences, Engineering, Computer Science, or a related field. At least 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, is also necessary.



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