Director of Quality Assurance

vor 4 Wochen


Ottobrunn, Bayern, Deutschland WuXi AppTec Vollzeit
Position Overview

As the **Director of Quality Assurance**, you will play a pivotal role in ensuring the highest standards of quality and compliance within our organization. Your expertise will guide our teams and facilities in maintaining excellence in all aspects of quality management.

Key Responsibilities
  • Provide strategic quality and compliance direction to staff and operational sites.
  • Facilitate timely resolution of quality-related issues to ensure uninterrupted project progression.
  • Lead initiatives focused on quality enhancement and ongoing improvement.
  • Conduct regulatory inspections to secure essential licenses and authorizations, supporting the review and certification processes.
  • Effectively allocate resources across various projects and activities, making necessary adjustments to meet quality and timeline requirements.
Reporting and Communication

In instances where a project poses a significant quality risk, it is imperative to promptly inform upper management and engage with clients, including proposing solutions and preventive measures.

Qualifications

The ideal candidate will possess:

  • A PhD or Master’s degree in pharmaceutical, chemical, or analytical sciences, or a related field.
  • Proficiency in drug product manufacturing processes and a thorough understanding of GMP regulations.
  • Over 10 years of experience in Quality Assurance or related roles within a regulated pharmaceutical environment, including more than 6 years in leadership and team management.
  • A minimum of 5 years of experience in the role of EU Qualified Person, with the necessary qualifications and certifications.
  • Exceptional presentation and communication skills in both German and English.

Your leadership will be crucial in fostering a culture of quality and compliance at WuXi AppTec, ensuring that all projects align with our commitment to excellence.



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