The Princess Máxima Center for Pediatric Oncology is a unique interdisciplinary institute that brings together all the highly complex care, research, and education to provide the best possible care for children with cancer. This concentration and integration of specialized pediatric oncology reflect our mission: to provide a cure and optimal quality of life for every child with cancer. Close cooperation between care and research will lead to more children being cured of cancer, with fewer adverse effects later in life.
The Princess Máxima Centre has initiated the design and building of a new Cell and Gene Therapy Facility (CGTF). In this facility, manufacturing Advanced Therapy Medicinal Products (ATMPs) will be our primary goal. Next to that we will participate in translational research.
To further shape the CGTF in this building phase, an exciting opportunity is available for an experienced and highly motivated Quality Assurance (QA) Specialist to join the new Cell and Gene Therapy Facility team.
Key responsibilities (included but are not limited to):
- Assist in, implementing, managing, and monitoring a GMP-based quality system for the CGTF.
- Responsible for obtaining and maintaining the WVKL license.
- Provide quality guidance and ensure that the production and control activities performed at the CGTF comply with GMP standards.
- Responsible for managing change controls, document control, deviations and CAPA systems.
- Assist in obtaining and maintaining all relevant regulatory and accreditation compliance and supporting continual improvement, ensuring compliance standards are met and exceeded.
- Participate in regulatory and accreditation inspections as required.
- Perform internal audits of the facility and procedures to detect deficiencies and external audits of suppliers and service providers as required.
- Analyze and present quality management data, including adverse incident outcomes, actions, and trends; audit non-compliances and corrective actions.
- Support the development of strategies to improve quality working practices and systems.
- Perform other QA duties as required by EudraLex standards or WVKL and different applicable regulatory/accreditation standards and duties as assigned by the line manager.
Profile
First of all, you master the ability to combine an analytical and resourceful approach, and are able to balance a varied workload. Additionally, you are able to establish empathetic connections with colleagues that therefore foster relationships and improve performance. You are motivated to pioneer, take self-initiative and are able to develop creative solutions to (complex) issues.
In addition, you have:
- Bsc or Msc degree in Biomedical, Life sciences or another relevant area and working experience in quality assurance and regulatory experience.
- Ideally experience in supporting QM activities at an AT(i)MP cell manufacturing facility and adequate knowledge of EU regulatory and accreditation framework required for the production of cellular therapy products.
- Adequate knowledge of WVKL licensing and JACIE standards.
- Excellent English writing and verbal communication skills are required, in Dutch will be a vital asset.
Working at the Princess Máxima Center
We offer a full-time position (based on 36 hours a week) in a very stimulating and interactive environment. The contract will be initially for one year, with the possibility to extend upon satisfaction. Your gross monthly salary (FWG 50-55) will be based on your experience and background and will include 8,33% holiday allowance and 8,33 % end-of-year bonus. The Princess Máxima Center operates according to the collective labor agreement ‘CAO ziekenhuizen’.
Contact and application
You can apply for this position by pressing the apply button on this screen. May we invite you to apply as soon as possible, since we will close the vacancy when we have found a suitable candidate. For more information about this position, or to arrange an informal chat, please contact: Adeel Saleem, Head of Cell Therapy Facility.
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