This organization focuses on gene therapy to treat immunological diseases (ex. Huntington Disease, Parkinson's Disease, Haemophilia) using AAV-based vectors. Having several products in the pipeline, they are all of them in different stages of development and clinical trials phases.
As a Head of QC you will manage the QC department which is responsible for monitoring the products and raw materials quality. QC is also responsible for the Environmental Monitoring (EM) in the clean rooms.
- Coordinating day-to-day management of the QC department, including planning of activities and resources, guidance/performance review and communication lines with other departments.
- In-house testing activities to ensure product quality
- Environmental monitoring of the GMP production
- Outsourcing activities
- Transfer activities
- Ensuring compliance to national and international regulations and pharmacopoeia, and making continuous improvements accordingly
- Managing the implementation/maintenance/continuous improvement of the Quality System (SOPs, AIMs, equipment records, personnel training...)
- Oversight documentation related to quality indicators: (planned) deviations, change controls, and OOS.
- Oversight of QC projects milestones
- MSc in Biology, Chemistry, Biotechnology, or equivalent
- Min. 5 years of experience in a similar role
- Min. 2 years of experience in people management (5+ FTE)
- Experience in a biopharmaceutical GMP environment
- Knowledge of EudraLex, CFR, ICH guidelines and industry regulations
- Experience in quality systems development and continuous improvement
- Analytical background and know-how, preferably with vaccines or viral-based products
- Experience with QC related quality systems and data management systems
For more information please contact Carla Garcia at firstname.lastname@example.org or +31 (0) 20 658 98 01.