• Responsible for ensuring that all investigational and potential commercial drug products are manufactured in accordance with client’s requirements and in compliance with the cGMPs.
  
• Responsible for timely review and release/disposition of clinical trial supplies/ drug product to support client’s goals.
  
• Oversee qualification, performance tracking, and manage health authority inspections, and internal/external audits. Provide recommendations for corrective and preventative action to the functional areas
  
• Review and approve analytical/stability protocol, data and reports, maintain stability data base, review and approve micro testing and report. Approve and issue specifications, and methods for drug products
  
• Review and approve IQ/OQ/PQ and validation protocols for manufacturing equipment and facility, support qualification/validation of GxP related computer based systems. Maintain Quality documentation files, databases, and logs.
  

• Extended experience in Quality Assurance with demonstrated increasing expertise and responsibility in the pharmaceutical industry
  
• Previous experience in building and leading Quality Assurance group, and ability to influence others and able build a company culture of quality
  
• Expert knowledge of FDA and ICH quality regulations with respect to all aspects of drug development; clinical, nonclinical and CMC
  
• Experience in bringing products from clinical to commercial and understanding appropriate GMP requirements.
  
• Strong understanding of manufacturing processes for drug products. Experience with electronic data systems preferred
  
• Excellent written and verbal communication skills
  

LOCATION

Pudong District, Shanghai City

CONTACT

Please send your resume to: elsa_li@wuxiapptec.com