Expert Quality Engineering

Expert Quality Engineering

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.

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.

We are searching for the best talent for an Expert Quality Engineering to be in Gent.

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.

You will be responsible for:

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: 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.

Qualification and Requirements:

• Educational Background: A degree in Pharmacy, Biotechnology, Bio-engineering or a related field.

• Experience: Minimum 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. 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.

• 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.

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