Senior QA Director (STA Qualified Person)

WuXi AppTec

Karlsfeld

(Senior) Director of Quality Assurance (STA Qualified Person (QP))

Location: Germany, Munich, but willingness to travel and stay at WuXi STA Couvet, Switzerland site.
• Coordinate WuXi STA's QP organization based in Germany
• Set up WuXi STA's QP office and hold ownership of the related systems and processes.
• Be responsible for QP certification of WuXi STA's manufactured products on behalf of clients for clinical and commercial products.
• Provide quality and compliance guidance to STA staff and sites. Assist in quality issue resolution in a timely manner to ensure smooth progress of projects. Drive quality improvement projects and continuous improvement.
• Host regulatory inspections to obtain necessary licenses and authorizations to support QP review and certification processes.
• Host major client audits related to STA QP organization and ensure successful completion of these audits.
• Properly allocate resources to all projects and activities. And make adjustments whenever is... More Detail

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