Quality Assurance Executive

vor 1 Monat

Planegg, 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. This position requires a strong commitment to quality management and regulatory adherence.

Key Responsibilities
  • Provide expert quality and compliance guidance to staff and various sites.
  • Facilitate timely resolution of quality issues to maintain project momentum.
  • Lead initiatives aimed at quality enhancement and continuous improvement.
  • Oversee regulatory inspections to secure necessary licenses and authorizations.
  • Efficiently allocate resources across projects and activities, making adjustments as necessary to meet timelines and quality standards.
  • Report significant quality impacts to upper management and communicate effectively with stakeholders, 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 an equivalent qualification.
  • Proficiency in drug product manufacturing processes and GMP regulations.
  • Over 10 years of experience in Quality Assurance or related fields within a regulated pharmaceutical environment.
  • A minimum of 6 years in leadership and team management roles.
  • At least 5 years of experience as an EU Qualified Person, with the necessary qualifications and certifications.
  • Exceptional presentation and communication skills in both German and English.
  • Demonstrated expertise in problem-solving, communication, quality system implementation, and team development.

This role is essential for maintaining our commitment to quality and regulatory compliance, ensuring that all projects align with the highest standards.

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