Senior QA Associate Release CAR-T Europe

Job title:

Senior QA Associate Release CAR-T Europe

Company:

Johnson & Johnson

Job description

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 atJohnson & 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.What you will be doing:

• 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

QualificationsWe would love to hear from you, if you have the following essential requirements:

• 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

What type of mark will YOU make?By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work at Johnson & Johnson you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.Diversity, Equity & Inclusion at Johnson & Johnson means “YOU belong”!For more than 130 years, diversity, equity & inclusion 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 every one of our people feels that they belong and can reach their potential. No matter who they are.

Expected salary

Location

Gand, Flandre-Orientale

Job date

Sat, 22 Jun 2024 01:35:29 GMT

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