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Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Gent, East Flanders, Belgium
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 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 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.
Here’s what you can expect:
- Application review: We’ll carefully review your CV to see how your skills and experience align with the role.
- Getting to know you: If there’s a good match, you’ll 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.
Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA
Required Skills:
Preferred Skills:
Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards
