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Global Quality Compliance(GQC)

Quality and compliance are core values embedded in our culture to assure the biopharmaceutical products manufactured at WuXi Biologics are of the highest level of efficacy and safety per  our customers expectations. Global Quality Compliance (GQC) is committed to establishing and implementing the global quality system to assure consistency and execution across departments and sites in various countries. GQC currently houses five groups: -Global Quality System, Global Audit, IT Quality, Internal Compliance and Risk Analytics.

  • Maintaining the Global Quality System
  • Leading all quality compliance efforts
  • Providing quality and compliance guidance to site staff and leadership teams on issues related to manufacturing, testing, quality system and regulatory compliance 
  • Monitoring the key quality index of each site
  • Maintains company audit schedule 
  • Support client quality audits and share feedback to all relevant teams within the organization
  • Computer System Quality

 

    • Define and maintain CSQS (computerized system quality system), provide guidance for CSQS implementation across all sites.
    • Provide computerized system quality support for new sites.
    • Provide quality assurance for global computerized systems & IT infrastructure to make sure system validation and operation meet the regulation requirements.

 

  • Data Governance

 

    • Define and sustain data governance strategies, policies and framework
    • Implementing meaningful and effective strategies on data management and data integrity risks based on current regulatory expectations.
    • Align requirements and oversight on Quality System Software Applications (Trackwise and MasterControl) across sites
  • Collaborate with local site QA auditing teams and Global Auditing team to analysis observations (trending).   And ensure regulation complied solutions are defined and implemented in all sites.
  • Collaborate with Global Data Risk Analysis team and Global Quality System team to collect quality data to monitor potential risks/gaps and improve them respectively.
  • Compliance knowledge share management.  Create and run compliance forum to identify gaps/risks in corporate quality system based on current regulatory environment, guides and regulation. 
  • Analyze quality related data, including but not limited to deviation, change control, CAPA and audit observations through pre-established models
  • Establish and maintain corporate quality data analysis platform 
  • Support overall monitoring of quality compliance state across sites and identifying of potential risks