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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.

Qualifications

• Master Scientific degree with a technical specialization in analytics / chemistry / biotechnology / pharmaceutical sciences / engineering (or equivalent through experience).
• In-depth knowledge of c GMP (domestic & international), ICH guidelines, policies, standards and procedures.
• 5-10 years of experience in Quality Systems or Quality Assurance related to manufacturing is required.
• Experience with Data Analysis and continuous improvement methodologies is an asset.
• Experience in people leadership is a must.
• Experience with Health Authority inspections is an asset.
• You work accurately and proactively seek solutions.
• You have good verbal and written communication skills.
• You speak and write Dutch and English fluently.
• Strong analytical thinking skills and able to work in a flexible way under time pressure in local and global teams. Ability to make risk based decisions under time pressure. Understands the business implications regarding quality positions and decisions.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.