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QA Project/Operation Manager MES CAR-T EMEA - 2406194382W

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 innovationempowers 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 Senior QA Project Engineer 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 build two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories are located in the existing Janssen Beerse site.

The QA Project/Operations Manager, CAR-T Europe is the Quality lead and Voice for the MES implementation at the CAR-T sites in Ghent.

What you’ll do.

Key activities include, but are not limited to:

Project and Operational Quality Performance:

• Provide quality assurance (QA) support to the MES CAR T project team, ensuring the project meets customer specifications

• Translation of production processes to MBRs and related master data take into account the strict procedures specific to the pharmaceutical industry

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

• Responsible for QA support of Master batch records (including training and guidance) and occasionally also after office hours

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

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

• Active participation in project teams, operational teams & system teams

• Leading improvement projects in the context of quality and improvement projects

• Close collaboration with operations, IT & automation

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

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:

• Bio-Engineer or Industrial Pharmacist with at Least 7 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 in both Dutch and English 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: Friday, 21 st of June, 2024.

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

Organization Janssen Pharmaceutica N.V. (7555)

Job Function Quality Assurance

Req ID: 2406194382W