QA Investigations Associate

Applies in-depth knowledge of Quality Assurance best practices and surfaces issues that may impact organizational objectives.
Documents critical Quality Assurance issues in product processes and tracks regulatory changes.
Conducts routine collection and dissemination of feedback to ensure continuous improvement of the quality management system.
Completes processes to ensure the internal organization's alignment with overall quality priorities.
Implements formal escalation processes to surface issues in product processes, regulatory compliance, and quality systems.
Analyzes complex research and data related to regulatory changes, external trends, and strategy.
Coaches more junior colleagues in techniques, processes, and responsibilities.
Understands and applies Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with team.

QA Investigations Associate CAR-T (Belgium, on site)

Johnson & Johnson (J&J) is recruiting a QA Investigations Associate CAR-T (Belgium, on site), 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 blood cancer treatment that uses the strength of the patient's own immune system.

The patient's T-cells are genetically modified to eliminate the cancer cells.

This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results.

We are therefore working passionately on expanding our capacity for CAR-T treatments in Europe, both at our existing site in Beerse (QC laboratories) and in Ghent, where we have built two CAR-T manufacturing centers in the Ghent area (Belgium).

We are looking for strong talents who are eager to participate in this innovative and hopeful venture.

The QA Investigations Associate CAR-T, CAR-T Europe is part of the QA/QP Operational team and is responsible to ensure that product and process related investigations, complaints, escalations and change controls are properly handled on time and in line with all ATMP/GMP requirements.

Key Responsibilities:

Provide quality support and oversight on investigations pertaining to the operational activities within the Ghent CAR-T facilities.
Support in-depth investigations by providing quality and compliance expertise.
Ensure that deviations/complaints are timely and properly investigated by providing quality & compliance expertise.
Ensure that 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.
Contribute to the impact assessment and evaluation of assigned Change Controls.
Ensure timely QA approval of GMP documentation and provide support in quality review meetings.
Drive continuous improvement.
Establish and maintain effective working relationships with the different business partners and Legend Biotech to ensure alignment of objectives and deliverables.Qua...