Qualified Person (QP) - Quality Assurance

We are looking for the best talent for a Qualified Person – Quality Assurance for the CAR-T hub to be in Ghent Belgium!

Purpose: CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.

To support the CAR-T program in EMEA, J&J has built two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories are operating from the existing J&J Beerse site. CAR-T investigational medicinal and commercial CAR-T products are manufactured in the Ghent facilities.

In this role, you are reporting in the J&J QA CAR-T organization and work closely with your peers from Material Science and Technology, Operations and Quality Control.

The Qualified Person, CAR-T Europe is responsible that product and process related investigations, complaints, batch review and release activities are accurately handled on time and in line with all ATMP/GMP requirements.

As a Qualified Person - QA, you will:

• Review and approve batch documentation to verify compliance with regulatory and company standards. Release of incoming raw and starting materials and Final Drug Product release.
• Provide technical, quality, and compliance expertise to support in-depth investigations related to deviations, complaints, and other quality issues to ensure timely resolution.
• Ensure that deviations and complaints are promptly and thoroughly investigated, with particular attention to those that may affect patient safety or product supply. Raise issues that could have significant impacts on quality.
• Ensure that appropriate corrective and preventive actions (CAPAs) are identified and implemented in response to investigations, especially those with potential impacts on product quality and patient safety.
• Assist in the preparation, execution, and follow-up of internal and external inspections and audits to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
• Contribute to the quality oversight programs by providing documented QA approval for GMP documentation and actively participating in quality review meetings to support operational activities.
• Foster and maintain effective working relationships with internal teams, business partners, and external collaborators (e.g., Legend Biotech), ensuring alignment with quality objectives and results.

Qualifications/Requirements:

• A degree in Pharmacy or Bio-engineering is required. Certification as an Industrial Pharmacist is required (Qualified Person number).
• In-depth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release, and distribution processes.
• Regulatory Knowledge: Up-to-date knowledge of pharmaceutical legislation, including current Good Manufacturing Practices (cGMP) and Advanced Therapy Medicinal Products (ATMP) regulations.
• Strong analytical thinking and decision-making abilities, with a keen attention to detail.
• Excellent verbal and written communication skills to optimally negotiate and interact with both external and internal customers and partners.
• Proven experience working with quality systems, ensuring compliance with industry standards and regulatory requirements.
• Experience with aseptic processing and techniques is preferred, with a solid understanding of the requirements for sterile manufacturing.
• Highly organized, capable of managing multiple tasks in a team environment, and able to work optimally under minimal direction while maintaining a positive demeanour.
• Effective Communication: Strong written and verbal communication skills in English is required. (Dutch is a plus)

Hybrid Work