Interested in becoming part of the innovative CAR-T manufacturing program at Janssen? (Ghent) We are  looking for an experienced Senior QA Project Manager to support this exciting project.

Are you a science minded, solution oriented QA professional in the pharmaceutical industry, with a degree in Bio-engineering or Industrial Pharmacy (or similar)? Have you built your expertise preferably in aseptic processing, cell and gene therapy production environment? People management experience?

Please find the details for this great opportunity below.

To support the CAR-T program in EMEA, Janssen is building two CAR-T manufacturing centers in the Ghent area.

The Senior QA Project Engineer, CAR-T Europe is the Quality voice and responsible for providing QA support to the CAR-T operation project team.

Major Responsibilities:

Project and Operational Quality Performance:

• Provide quality assurance (QA) support to the CAR-T project team, ensuring the project meets customer specifications
• 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 and Legend Biotech 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

Experience & Skills:

• Bio-Engineer or 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.
• Experience working with Quality systems is required.
• Experience with aseptic processing and technics is required
• High level of English and a good understanding of Dutch
• Strong analytical thinking and decision-making skills.
• Well developed people management skills.
• Excellent verbal and written communication skills to 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.
• Good written and verbal communication skills are required.
• Reside in Belgium

Offer:

You will become part of a very important program at Janssen and receive a fixed contract with a competitive salary package, including fringe benefits.

Contact:

Please don't hesitate to apply here today or to get in touch with Katleen Broeckhoven via email to katleen@careforceone.be for more information.

Looking forward to meeting you...!