Director of Quality Assurance

职位描述：

• 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.

职位要求：

• 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.

WuXi AppTec

公司介绍

Established in December 2000, WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with operations in China and the United States. As an innovation-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services throughout the drug R&D process. Our services are designed to help our worldwide customers shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions.
WuXi AppTec has successfully established a fully integrated services and technology platform during the past decade. The company built its initial capabilities around discovery chemistry and has further enhanced the integrated services with analytical services, bio-analytical services, process research, process development services, API manufacturing services, DMPK/ADME, discovery biology, pharmacology, formulation, toxicology, genomic services, biologics manufacturing services, antibody and biological research reagent manufacturing and sales, and most recently clinical research and regulatory services.
WuXi AppTec has developed from four founders and a single laboratory in December 2000 to 10,000 employees and 5 million square feet of laboratory and manufacturing space, including facilities under construction. The company is actively improving its capabilities and capacity through new expansions in its global business. Capitalizing on the great advantage of conducting R&D services both in China and in the U.S., WuXi AppTec is building an alternative R&D engine to serve the global life-science industry.

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