Job Purpose:
Quality and Compliance are the core value embedded in WuXi Biologics, GQC is committed to establish and implement the global quality system for our business expansion, to assure the highest level of efficacy and safety of biopharmaceutical products. Lead Global Quality Compliance Department, to assure the consistency of our quality system and the execution across departments and sites in various countries.
Key Responsibilities
1. Establish Global Quality Management System, and lead continuous improvements of Quality System.
- Maintaining Global Quality System and Structure.
- Leading Quality Compliance efforts.
- Provide quality and compliance guidance to site staff and leadership team on issues related to manufacturing, testing, quality system and regulatory compliance
- Monitoring the key quality index of each site.
2. Manage internal audit programs and external audits to ensure Quality compliance at all WuXi Biologics sites.
- Coordinate client audit for multiple-site audit
- Support regulatory inspections by domestic and international regulators.
- Lead compliance forum, to ensure the alignment and adherence to the global quality system across sites.
- Collaborate with Global Data Risk Analysis team and Global Quality System team to collect quality data.
- Identify the potential compliance risk via tracking the new regulation/the inspection trend and assessing the historic data (data base of external & internal findings) for the internal audit focus
- Audit finding and compliance knowledge sharing
- Create and manage a system to handle escalations from site level to global quality management team
3. Manage the Data Analysis team, establish and maintain corporate quality monitoring indicators.
- Standardize quality data including but not limited to deviation, CAPA, CC, audit data from all sites.
- Generate analysis model and present outcome in the form of dashboard for each site
- Drive risk related topics from dashboard and share with sites and GQC.
4. Lead Computer Systems Quality (CSQ) and Data Governance (DG) groups to overhaul the WuXi Biologics Computerized System and Data Governance Quality System.
- Provide strategic quality guidance for computerized systems and data governance based on regulatory, IT QMS, and industry best practices, lead the development of system specific validation plans and strategy using a risk-based approach, etc.
- Ensure all GMP computerized systems (infrastructure, General IT system) are properly validated prior to go-live.
- Champion the effort of preparations (computerized systems and data integrity) for audits from customers and inspections by regulatory bodies
- Work closely with business areas including but not limited to manufacturing, quality control, and IT to achieve and maintain compliance of computerized systems and data integrity.
- Resolve all issues related to computerized system and DI compliance during routine quality operation, internal/external audits, health authority (HA) inspections and client audits.
- Provide CSQ and DI training across the company.
5. Recruit, develop and train talents to meet business needs.
6. Other tasks and responsibilities assigned by supervisor
REQUIREMENTS
- More than 15 years in biopharmaceutical manufacturing, quality or process development
- More than 10 years of experiences in quality management
- Expertise in cGMP compliance
- Fluent in English, both verbal and written
- Good communication skills
- Excellent leadership skills