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Senior QA Director

vor 4 Monaten


Planegg, Deutschland WuXi AppTec Vollzeit
span>(Senior) Director of Quality Assurance (STA Qualified Person (QP))

 

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.Properly allocate resources to all projects and activities. And make adjustments whenever is needed, ensuring that every project meets timeline and Quality requirements.When significant quality impact of a project is identified, immediately report to upper management and communicate with the customers (including proposal for solution and prevention).
  • PhD/Master in pharmaceutical, chemical or analytical sciences or equivalent degree. Be proficient in drug product manufacturing processes, support and GMP regulations.
  • More than 10 years experience in Quality Assurance or other relevant functions in regulated pharmaceutical environment; more than 6 years people leadership and team management experience.
  • More than 5 years in EU Qualified Person role, necessary qualification and certification to act as EU Qualified Person
  • Excellent in presentation and communication in German and English
  • Demonstrate ability in problem solving, communications, quality system implementation and team building.
  • Proven ability to motivate, mentor and work efficiently, as well as with persons from other cultures, as in cross-functional and self-directed work teams