GxP Compliance Manager

18 hours ago


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

We are a global company with over 1,800 employees in more than 30 countries, committed to the societies where we operate. Our mission is to make a positive impact in the lives of people affected by rare diseases.

Our Vision

We strive to be a leader in the pharmaceutical industry, driven by innovation and a passion for making a difference. We believe that every individual deserves access to life-saving treatments, and we are dedicated to helping patients and families affected by rare diseases.

This role will play a crucial part in achieving our vision by ensuring eCompliance and driving digital quality decisions through effective GxP system lifecycle management and quality data stewardship.

Main Responsibilities
  • Act as Business Admin for GxP systems, ensuring eCompliance through comprehensive GxP system lifecycle management.
  • Collaborate with Cross-Functional Teams to identify opportunities for process improvements and quality automation across the GxP arena.
  • Oversee Quality Data Stewards to ensure adherence to relevant quality and regulatory requirements within the GxP field.
  • Support CSV Activities, inspections, internal audits, follow-up activities, and remediation guidance.

Key Qualifications

  • Documented education in Natural science, chemistry, pharmacology, pharmaceutical development, IT or corresponding work experience within IT and or the GxP area.
  • Minimum of 5 years of experience in GxP compliance, quality assurance, or a related field within the pharmaceutical industry.
  • Strong knowledge of GxP processes and computerized system validation (CSV) standards.
  • Experience with digital quality systems and tools, including Veeva QMS, SQM, and training modules.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

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