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QA Director

Responsibilities:

  • 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.


Basic Qualifications:

  • 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