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Senior QA Associate Release CAR-T Europe - 2406177179W

Description

Johnson & Johnson (J&J) is recruiting a Sr 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 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.

In this role, you are reporting in the QA/QP organization and work closely with your peers from Quality Assurances Operations and Quality Control.

The Sr QA Associate, CAR-T Europe is responsible that product and process related investigations, complaints, batch records reviews are properly handled on time and in line with all ATMP/GMP requirements.

Major Responsibilities:

• Support in-depth investigations by providing technical, quality and compliance expertise

• Ensure that deviations/complaints are timely and properly investigated. Deviations/complaints with potential impact on patients and/or product supply are properly escalated

• Ensure that adequate CAPA’s are defined for investigations with potential quality impact

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

• Participate to the quality oversight programs of the operational activities by documented QA approval of GMP documentation and support in the different quality review meetings

• Establish and maintain effective working relationships with the different business partner and Legend Biotech to ensure alignment of objectives and deliverables

• Ensure and manage the implementation and execution of the different quality system processes

• Support the operational and QA departments by providing coaching and/or training

• Review of batch documentation and review analytical results

Qualifications

Experience and Skills:

• Certified Industrial Pharmacist with at Least 3 years cross functional experience in pharmaceutical industry.

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

• 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 as well as knowledge of Good Tissue Practices.

• Strong analytical thinking and decision-making skills.

• Excellent verbal and written communication skills to negotiate and communicate with external and internal customer and partners.

• Experience working with Quality systems is required.

• Experience with aseptic processing and technics is required.

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

• Good written and verbal communication skills are required.

About 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/.

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

Organization Janssen Pharmaceutica N.V. (7555)

Job Function Quality Engineering

Req ID: 2406177179W