- Set up goals for Quality systems aligned with the corporate quality goals/objectives
- Ensure that WuXi Bio’s quality systems are comprehensive and in full compliance with the cGMP & regulatory requirements of FDA, EMEA, CFDA.
- Continuously improve the established quality systems, based on the new regulations / guidance
- Provide hands-on guidance on the quality systems implementation and execution
- Capable of making critical decisions on the escalated quality issues or further escalation
- Oversee the execution of major quality programs such as NPI/Tech transfer, Material management, Facility/Equipment/Instrument management, Validation, Drug Manufacturing, QC operations, Environment Monitoring, Deviation/CAPA, OOS investigation, Custom Complaint, Change Control, Risk Management, Auditing, Training, Document Management, Quality Metrics (KQI/KPI), etc.
- College degree or above with a major in chemistry, biology, biochemistry, chemical engineering, bioengineering, or related field.
- Extensive knowledge in regulations of health authorities such as FDA, EMA, CFDA.
- More than 8 years direct working experience in QA operation in pharmaceuticals/biotech manufacturing or related fields, experience in clinical drug manufacturing preferred.
- More than 5 years management experience
- Solid knowledge and experience in GMP operations
- Expert in quality systems in bio/pharmaceutical manufacturing
- Excellent communication skills, fluent in both Chinese and English in oral and writing
Job Function: Research & Development
Primary Location: China-Shanghai