Investigation Coördinator

CAR-T is an innovative blood cancer treatment that uses the strength of the patient's own immune system. The patient's T-cells are genetically modified to eliminate the cancer cells. This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results.

We are therefore working passionately on expanding our capacity for CAR-T treatments in Europe, both at our existing site in Beerse and in Ghent, where we have developed a new production site. We are looking for strong talents who are eager to participate in this innovative and hopeful venture.

The Innovative Medicine Supply Chain Group, a member of the Johnson & Johnson family of companies, is therefore recruiting a QC CAR-T investigation coordinator for the CAR-T hub in Europe. The position will be based in Beerse Belgium.

Your tasks and responsibilities with the QC team are the following:

- Support daily operations within QC, work closely together with supervisors, analysts, production, warehouse and QA.
- Leading complex investigations and writing a final investigation report based on a thorough
- root cause analysis. You define, implement corrective actions and monitor their effectiveness, ensuring timely execution and closure. If it concerns a cross-departmental QC investigation, you will manage a multi-disciplinary team. You are the QC representative in cross-departmental investigations.
- Supporting, initiating and implementing improvement projects for the team in the areas of safety, quality, efficiency and customer satisfaction.
- Develop training/awareness sessions within QC.
- Providing support during health authority inspections, including by preparing substantive questions.
- Monitoring and streamlining the quality level within the various labs.

**Qualifications**:

- A minimum of a Master’s degree in a biochemistry and biotechnology related degree
- Knowledge of cGMP regulations and FDA/EU guidance is required.
- High organizational skills and independent and flexible way of working are required.
- Excellent written and oral communication skills are required
- Professional experience in a GMP-regulated environment, preferably in the area of quality control, is an advantage
- Very good knowledge of using Microsoft Office programs
- A good knowledge of laboratory processes and systems is preferred