At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

QA Associate CAR-T (weekend)

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 patients 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 Operations and Quality Control.

The QA Associate CAR-T (weekend) is responsible to take part in and oversee the release activities which take place during the weekend shift i.e. release of batches in line with all ATMP/GMP requirements whilst adhering to the established turn around timelines.

This position will involve working in a weekend shift (6AM - 6PM) on site.

Major Responsibilities:

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

• Quality Assurance Oversight: Monitor and ensure adherence to Good Manufacturing Practices (GMP/ATMP) and other relevant quality standards during the manufacturing of CAR T-cell products. Provide guidance during the weekend in relation to the QA oversight on manufacturing and logistics processes.

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

• 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: 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

Flexibility in Working Hours: This function requires working in a weekend regime from 6 AM to 6 PM And this position may involve flexible working hours depending on business requirements and/or hand-over needs.

The initial training period will commence in dayshift during the week until training is complete.

Experience and Skills:

• Educational Background: Certified Industrial Pharmacist with a Qualified Person accreditation is preferred . A degree in Pharmacy with at least 3 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.

• 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.

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Heres what you can expect:

• Application review: Well carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Required Skills:

Preferred Skills: