Sr QA Associate CAR-T EMEA (1 of 2)

at  Johnson Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com/.
Johnson & Johnson (J&J) is recruiting a Sr QA Associate, QA Operations/Project Support Lead 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 constructed two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing J&J Beerse site. CAR-T investigational medicinal and commercial CAR-T products are manufactured in the Ghent facilities.
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.
The Sr QA Associate, QA Operations/Project Support Lead, CAR-T Europe is responsible to ensure QA operational support and enhancements to the QA processes in line with all ATMP/GMP requirements.

Major Responsibilities:

• 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.
• Project Management: Manage quality aspects of CAR T-cell therapy projects, ensuring milestones and deliverables are met in alignment with project timelines and objectives.
• Risk Management: Conduct risk assessments for CAR T projects, identify potential quality issues, and develop mitigation strategies to address identified risks.
• Document Control: Review and approve project-specific documents, including protocols, standard operating procedures (SOPs), batch records, and validation reports.
• Deviation & CAPA Management: Investigate deviations, non-conformances, and implement corrective and preventive actions (CAPAs) to ensure process integrity and product quality.
• Change Control: Evaluate and implement changes related to CAR T-cell processes, equipment, and materials, ensuring all changes comply with quality standards and regulatory requirements.
• Audits & Inspections: Prepare for and participate in internal and external audits and inspections. Lead audit response activities and implement corrective actions as necessary.
• Collaboration: Collaborate with internal teams and external partners to support the project from development to manufacturing, ensuring quality requirements are met at all stages.
• Continuous Improvement: Establish and maintain effective working relationships with the different business partners and Legend Biotech to ensure alignment of objectives and deliverables.

QUALIFICATIONS

• Education: Bachelor’s or Master’s degree in Pharmacy, Engineering, Biotechnology, or a related field.
• Experience: Minimum of 5 years of experience in quality assurance or project engineering within the pharmaceutical or biotechnology industry.
• Experience with cell and gene therapy, specifically CAR T, is preferred.
• Regulatory Knowledge: Strong understanding of regulatory requirements, including FDA, EMA, GMP/ATMP and ICH guidelines for CAR T-cell products.
• Technical Skills: Proficiency in quality management systems (QMS), process validation, and risk management tools.
• Soft Skills: Excellent project management, communication, and problem-solving skills. Ability to work effectively in cross-functional teams.
• Certifications: Relevant certifications (e.g., Six Sigma, Black/Green/Yellow belt) are a plus.
  We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
  Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability

• 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.
• Project Management: Manage quality aspects of CAR T-cell therapy projects, ensuring milestones and deliverables are met in alignment with project timelines and objectives.
• Risk Management: Conduct risk assessments for CAR T projects, identify potential quality issues, and develop mitigation strategies to address identified risks.
• Document Control: Review and approve project-specific documents, including protocols, standard operating procedures (SOPs), batch records, and validation reports.
• Deviation & CAPA Management: Investigate deviations, non-conformances, and implement corrective and preventive actions (CAPAs) to ensure process integrity and product quality.
• Change Control: Evaluate and implement changes related to CAR T-cell processes, equipment, and materials, ensuring all changes comply with quality standards and regulatory requirements.
• Audits & Inspections: Prepare for and participate in internal and external audits and inspections. Lead audit response activities and implement corrective actions as necessary.
• Collaboration: Collaborate with internal teams and external partners to support the project from development to manufacturing, ensuring quality requirements are met at all stages.
• Continuous Improvement: Establish and maintain effective working relationships with the different business partners and Legend Biotech to ensure alignment of objectives and deliverables