QA Cryo Lead

Johnson & Johnson seeks a QA Cryo Lead to oversee quality assurance for a CAR-T cryopreservation center in Belgium. The role combines leadership of QA associates with responsibility for nonconformance management, regulatory compliance, and cross-functional collaboration in an advanced cell therapy manufacturing environment.

Responsibilities

• Lead and develop team of QA associates to achieve quality and performance objectives
• Oversee end-to-end nonconformance and CAPA management with risk-based decision making
• Coordinate key GxP processes including batch release, deviation management, and change control
• Collaborate with cross-functional teams on project quality oversight and operational issue resolution
• Drive implementation of regulatory requirements and identify continuous improvement opportunities

Requirements

• Master's degree in engineering, science, or equivalent technical discipline
• Minimum 5 years of relevant quality assurance and GxP manufacturing experience
• Fluency in written and spoken English and Dutch with strong communication skills
• Prior supervisory or team leadership experience
• Knowledge of cell and gene therapy, batch record review, and deviation management
• Familiarity with digital process systems (SAP, COMET, eLIMS) and MES platforms
• Understanding of Tissues and Cells Directive, GTP, and SOHO regulations preferred