Quality Assurance Manager
GxPeople is currently working with a global client who is seeking a Quality Assurance Manager to join their team in Germany.
- Develop and maintain Quality/Technical Agreements to align with legal contracts and regulatory requirements.
- Management of high impact exception events and CAPA ensuring events are appropriately assessed
- Review and approval of relevant Product Quality Reviews to ensure accuracy and completeness and management of actions to address any identified trends.
- Review and approval of complaint investigations arising from Contract Manufacturing Operations(CMO)/Supplier manufactured product and follow-up on complaint trend investigations for non-medical and medical (adverse events) complaints.
- Management of all changes related to CMO/Suppliers which have a quality or regulatory impact, ensuring timely communication & implementation of changes in line with regulatory requirements.
- Maintain a Quality Management Review program and Quality Performance Measurement for CMOs / Suppliers, that identify and address quality, operational, and organizational issues.
- Participate on QA cross-functional teams to support CMOs, including active participation in Business Management Reviews or Workstreams, as necessary.
Qualifications and Experience
- Academic background in a relevant scientific discipline or other technical/scientific
- Minimum 7 years in QA, operations or pharmaceuticals engineering
- Excellent communication skills
- Leadership experience
- Fluent in English and German
For more information or, if you’d like to be considered for this position please call us on +44 20 3637 4393 or email firstname.lastname@example.org.