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QA Manager CAR-T EMEA - 2406202373W

Description

• Flexible work practices, award-winning benefits

• 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 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/.

THE OPPORTUNITY

How you can help.

The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Manager 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, Janssen has built two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site.

The QA Manager, CAR-T Europe is responsible for the release of CAR-T investigational medicinal and commercial CAR-T products manufactured in the Ghent facilities.

What you’ll do.

Key activities include, but are not limited to:

QA Release Responsibility:

• Lead a group of QA Associates that is responsible for the release of both investigational medicinal and commercial CAR-T products out of the Janssen/Legend Biotech facilities in Ghent

Operational Quality Performance:

• Act as an expert resource in assessing and maintaining quality and compliance levels

• Continuously challenging the status quo and lead the development and implementation of breakthrough initiatives that deliver sustainable improvement in organizational and quality performance

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

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

• 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

Management of Quality Issues/Complaints:

• 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

Management of Inspections/Audit:

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

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:

• Certified Industrial Pharmacist with at Least 5-8 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.

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: Sunday 4th of August, 2024.

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

Organization Janssen Pharmaceutica N.V. (7555)

Job Function Quality Assurance

Req ID: 2406202373W