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Job Description:

ohnson & 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 build 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 QA Associate, CAR-T Europe is responsible that product and process related investigations, complaints, batch review and release activities are properly handled on time and in line with all ATMP/GMP requirements.

Major Responsibilities:

Investigation Support: Provide technical, quality, and compliance expertise to support in-depth investigations related to deviations, complaints, and other quality issues to ensure timely resolution.

Deviations and Complaints Management: Ensure that deviations and complaints 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.

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.

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.

Collaboration and Stakeholder Engagement: Foster and maintain effective working relationships with internal teams, business partners, and external collaborators (e.g., Legend Biotech), ensuring alignment with quality objectives and deliverables.

Batch Documentation Review/Release: Review and approve batch documentation to verify compliance with regulatory and company standards.

Flexibility in Working Hours: The position may involve flexible working hours, depending

on project demands or business requirements.

Experience and Skills:

• Educational Background: A degree in Pharmacy or Bio-engineering, with at least 3 years of cross-functional experience in the pharmaceutical industry. Certification as an Industrial Pharmacist is a plus.

• Pharmaceutical Knowledge: 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.

• 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.

• Effective Communication: Strong written and verbal communication skills, with the ability to convey technical and regulatory information clearly.

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