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Quality Assurance Specialist DACH

vor 2 Wochen

Zürich, Zürich, Schweiz Leo Pharma Inc. Vollzeit

We're on an ambitious path to become the leaders in medical dermatology worldwide. Our Quality International team shares a 'challenge accepted' mindset, guided by our winning behaviours of simplification, collaboration, and accountability. We're looking for a Quality Manager who can lead our team in the DACH region and execute all assigned projects.

The overall objective of this role is to ensure quality oversight and compliance across affiliates and partners within the DACH region. This includes developing and maintaining the GxP Quality Management System (QMS) in alignment with our 2030 strategy and supporting regional quality development. The role requires close collaboration with Global Quality and key stakeholders, as well as regional and affiliate goals.

Your Key Responsibilities:
  1. Manage Global Quality personnel in the DACH region.
  2. Execute all Global Quality projects assigned to Quality International.
  3. Oversee production at contract manufacturers and external pre-wholesalers.
  4. Supervise outsourced GDP/GMP-relevant activities in regulatory affairs.
  5. Develop and maintain Quality Management Systems.
  6. Ensure high competency levels in the department.
  7. Manage personnel, including goal setting, development plans, training, and pay reviews.
  8. Address and act on LEO Voice feedback.
  9. Maintain good stakeholder relations and resolve issues efficiently.
  10. Participate in compliance forums and share best practices.
  11. Engage in quality international team and leadership meetings.
  12. Lead or participate in improvement initiatives.
  13. Coach and develop employees.
  14. Attend relevant SLT meetings.
  15. Stay updated on regulatory legislation and implement necessary changes.
  16. Serve as the archive responsible person for GxP documentation.
  17. Manage relationships with authorities and ensure product quality in Switzerland.
  18. Coordinate with distributors on packaging, storage, and handling.