Director Compliance

vor 4 Wochen

Weampling, 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.Host regulatory inspections to obtain necessary licenses and authorizations to support QP review and certification processes.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.

  • Senior Director

    vor 1 Monat

    Weßling, Deutschland WuXi AppTec Vollzeit

    (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 GermanySet up WuXi STA’s QP office and hold ownership of the related systems and processes.Be responsible for QP certification of WuXi STA’s...

  • Regional Reliability, Maintenance and Engineering Manager

    vor 4 Wochen

    köln, Deutschland Amazon TA Vollzeit

    We are looking for a seasoned and accomplished Reliability Maintenance Engineering (RME) Manager to join our team at Amazon. In this senior leadership role, you will be responsible for managing a team of RME Area Managers, Engineers and Technicians to ensure the reliability and maintainability of our equipment and systems across a number of sites in our...