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Within J&J Innovative Medicine Advanced Therapies Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a QA Senior Manager – Quality Systems CAR-T (M/F/X). As member of our Quality team overseeing the Quality Systems (QS) processes, you will be based in Beerse, Belgium or 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.

J&J Innovative Medicine Advanced Therapies Supply Chain serves as Centre of Excellence for the manufacturing of CAR-T drug product for clinical and commercial purposes. The EMEA CAR-T Drug Product Supply Chain has two manufacturing sites in Ghent (Obelisc & Tech Lane) and the Cryo & QC activities in Beerse, Belgium.

As QA Senior Manager – Quality Systems CAR-T, you are Subject Matter Expert of the Quality System processes, such as change control, non-conformance management, document management, records management, training,… You drive the implementation at the Ghent Obelisc, Ghent Tech Lane & Beerse sites and ensure adherence to the Quality System. In this role you report directly to the Site Quality Head.

In this role you are responsible to:

• Establish and maintain effective and strong working relationships with Supply Chain, local and global quality functions of J&J Innovative Medicine and our collaboration partner Legend Biotech to ensure compliance with all quality system requirements.


• Act as QA Point of Contact for the Ghent/Beerse site ensuring QS are appropriately implemented and applied.


• Act as local Process Owner for Quality System processes such as change control, non-conformance handling, document management, records management and training by:

‒ Acting as local Subject Matter Expert, including ensuring GMP documentation is in place and training provided ensuring compliance with global regulations and J&J quality requirements.

‒ Providing support to local users and quality approvers.

‒ Driving the site to continuously strengthen related skill sets across the entire organization.

‒ Evaluating trends and defining appropriate actions.

‒ Defining, following up and concluding corrective and preventive actions related to the QS processes.

‒ Leading the periodic governance meeting to guarantee quality oversight, including escalation to senior management when risks are identified.

• Ensure that quality records such as change controls, non-conformances and CAPAs are timely and properly handled by providing quality, compliance and technical expertise such that the internal and external customer expectations are met.


• With focus on Quality processes, develop and foster an environment of innovative thinking through e.g. benchmark and training. Continuously challenge the status quo by identifying opportunities for continuous improvement.


• Lead the training and development team on quality-related topics and systems.


• Lead and participate in continuous improvement initiatives on the QS processes.


• Act as spokesperson during Health Authority inspections and customer audits.