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JOB DESCRIPTION:

Johnson & Johnson (J&J) is recruiting a QA Associate for the CAR-T hub in Europe. The position will be based in Ghent Belgium.
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 successful candidate will be responsible for ensuring that the manufacturing processes meet quality standards and regulatory requirements. This role involves working closely with cross-functional teams, including Technical Operations, Manufacturing, Vein-to-Vein department and Regulatory affairs, to drive continuous improvement and support the development and commercialization of CAR T-cell therapies.

Experience and Skills:

• Educational Background: Master in Pharmacy, Biotechnology, Bio-engineering or a related field.
• Experience: Minimum 1 years of cross-functional experience in the pharmaceutical industry.
• Pharmaceutical Knowledge: In-depth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release, and distribution processes. Experience with cell and gene therapy, specifically CAR-T, is preferred.
• Regulatory Knowledge: Up-to-date knowledge of pharmaceutical legislation, including current Good Manufacturing Practices (cGMP) and Advanced Therapy Medicinal Products (ATMP) regulations is preferred.
• Analytical and Decision-making Skills: Strong analytical thinking and decision-making abilities, with a keen attention to detail.
• Communication Skills: Excellent verbal and written communication skills to effectively negotiate and interact with both external and internal customers and partners.
• Quality Systems Experience: Proven experience working with quality systems, ensuring compliance with industry standards and regulatory requirements.
• Aseptic Processing Knowledge: Experience with aseptic processing and techniques is preferred, with a solid understanding of the requirements for sterile manufacturing

Investigation Support: Provide technical, quality, and compliance expertise to support in-depth investigations related to deviations to ensure timely resolution.
Deviation Management: Ensure that deviations are promptly and thoroughly investigated, with particular attention to those that may affect patient safety or product supply. Escalate issues that could have significant impacts on quality.
CAPA Management: 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.
Quality Oversight Participation: 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.
Inspection and Audit Support: 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.
Collaboration and Stakeholder Engagement: Develop and maintain effective working relationships with internal teams, business partners, and external collaborators (e.g., Legend Biotech), ensuring alignment with quality objectives and deliverables.

Experience and Skills:

• Educational Background: Master in Pharmacy, Biotechnology, Bio-engineering or a related field.
• Experience: Minimum 1 years of cross-functional experience in the pharmaceutical industry.
• Pharmaceutical Knowledge: In-depth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release, and distribution processes. Experience with cell and gene therapy, specifically CAR-T, is preferred.
• Regulatory Knowledge: Up-to-date knowledge of pharmaceutical legislation, including current Good Manufacturing Practices (cGMP) and Advanced Therapy Medicinal Products (ATMP) regulations is preferred.
• Analytical and Decision-making Skills: Strong analytical thinking and decision-making abilities, with a keen attention to detail.
• Communication Skills: Excellent verbal and written communication skills to effectively negotiate and interact with both external and internal customers and partners.
• Quality Systems Experience: Proven experience working with quality systems, ensuring compliance with industry standards and regulatory requirements.
• Aseptic Processing Knowledge: Experience with aseptic processing and techniques is preferred, with a solid understanding of the requirements for sterile manufacturing.

Organizational Skills: Highly organized, capable of managing multiple tasks in a team environment, and able to work effectively under minimal supervision while maintaining a positive attitude. #RPOAM