An industry-leading Pharmaceutical company is looking for an experienced Quality Manager to join as they grow their preclinical division at their Headquarters near Koln.
Key responsibilities of the Preclinical QA Manager include:
- Collaborate with program leaders and other SME to support the pre-clinical development
- Set up the quality plan and ensure its execution
- Build and manage a strong relationship to suppliers (CROs) by defining the quality governance
- Align the quality and audit-related strategy and planning, share subcontractor and Investigator Site audit outcomes and define mitigation
- Set up, negotiate and maintain Quality Agreements
- Implement the strategy and execute the audit program for preclinical studies and manage the CAPAs
Key requirements of the Preclinical QA Manager include:
- MSc in Natural Science, Pharmacy, Medical Doctor or comparable degree or adequate education
- In depth knowledge and extensive experience throughout all stages of development, planning, and execution of pre-clinical studies
- In depth knowledge of GLP/OECD regulations and guidelines
- Proven experience in providing quality input and consultancy into program and study teams
- Project management experience and ability to lead complex projects in a highly matrixed and highly outsourced model
- Fluent business English, German highly beneficial
- Willingness to travel worldwide
If you are interested in the position, send your CV or contact +44 203 758 8792 for more information.
