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.

Global Quality System
Global Audit
IT Quality
Internal Compliance
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