Senior Compliance Officer

15 hours ago


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

Sobi - Swedish Orphan Biovitrum AB (publ) is a global biopharmaceutical company dedicated to rare diseases. We are committed to making a positive impact on the lives of patients affected by rare diseases.

Job Description

The Senior Compliance Officer - GxP will lead and manage the Computer System Validation (CSV) process, ensuring e-compliance of GxP systems. This role involves overseeing Quality Data Stewards, evaluating and approving high-level quality concepts and documents, and supporting CSV inspections and internal audits.

Responsibilities
  • Develop and drive the digital Quality roadmap and process quality automation across the GxP arena.
  • Provide strategic leadership in the digital transformation of quality processes.
  • Maintain and update knowledge of GxP regulations and ensure compliance.
Requirements
  • 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.


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