Sr QA Associate CAR-T EMEA

Job Description - Sr QA Associate CAR-T EMEA (2406193629W)

Sr QA Associate CAR-T EMEA - 2406193629W

Description

· This position will be based in Ghent, Belgium.

Change lives for the better.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

THE OPPORTUNITY

How you can help.

Johnson & Johnson (J&J) is recruiting a Sr QA Associate, QA Operations 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 built 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 Sr QA Associate, QA Operations 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.

What you’ll do.

Key activities include, but are not limited to:

· Act as an expert resource/SPOC supporting the processes of the QA Operational/Project team.

· Finetune requirements to ensure fit-for-purpose processes contributing to QA release.

· Support in-depth investigations and complaints by providing quality and compliance expertise.

· Ensure that issues with potential impact on patients and/or product supply are properly escalated.

· Ensure that adequate CAPA’s are defined for issues with potential quality impact.

· Support inspection and audit readiness programmes.

· Support the preparation, execution and follow-up of inspections and audits.

· Train/Coach colleagues

· Participate to the quality oversight programs of the operational activities by documented QA approval of GMP documentation.

· Perform QA review of GMP documentation, e.g. risk management, APR, CPV,..

· Provide support in the different quality review meetings and quality improvement initiatives.

· Establish and maintain effective working relationships with the different business partners and Legend Biotech to ensure alignment of objectives and deliverables.

Qualifications

IT’S ALL ABOUT YOU

To be successful, you demonstrate the ability to communicate effectively at all levels within a virtual matrix environment. Further requirements include:

· You have a Master’s Degree in a scientific or technical field (Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry …) with at least 5 years cross functional experience in the pharmaceutical industry.

· A certified Industrial Pharmacist (Qualified Person) is a plus.

· Experience working in Quality Assurance is required.

· Experience with aseptic processing and technics is preferred.

· In-depth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release and distribution processes is required.

· Up-to-date knowledge and in-depth understanding of relevant pharmaceutical legislation related to clinical trials and cGMP regulations related to manufacturing of cell therapy products is an asset.

· Knowledge of Good Tissue Practices is considered a plus.

· You work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating cross-functional issues.

· Your verbal and written communication skills enable you to proficiently negotiate and communicate with external and internal customer and partners.

· Highly organized and capable of working in a team environment with a positive attitude under some supervision.

Being part of Johnson & Johnson can change everything, including YOU
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Closing date: Thursday, 27 th of June, 2024.

Primary Location

Primary Location

Europe/Middle East/Africa-Belgium-East Flanders-Ghent

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor 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.andEqual Employment Opportunity Posters GINA Supplement.

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