Quality Person in Plant

Responsibilities

• Provide quality oversight in the cleanroom through on-the-floor witnessing
• Act as the point of contact for operators regarding quality, process discipline, and documentation
• Monitor compliance with procedures in real-time and ensure correct interventions
• Perform periodic quality controls and audits on processes and documentation
• Lead the operational release process by reviewing production procedures and batch records
• Support the investigation and assessment of deviations, CAPAs, change controls, and complaints
• Ensure all tasks are performed in accordance with safety policies, quality systems, and cGMP requirements

Requirements

• Bachelor's degree in Life Sciences or relevant years of experience in pharma/biotech
• Preferably 2 years of experience in an aseptic production environment
• Fluency in English (written and verbal)
• Knowledge of cGMP regulations and FDA/EU guidelines for cell-based products
• Knowledge of Good Tissue Practices
• Strong communication and teamwork skills

Preferred Qualifications

• Knowledge of Dutch

About the Company

Legend Biotech is a global biotechnology company dedicated to developing, manufacturing, and commercializing innovative and life-saving cell therapies for diseases such as cancer. In Ghent, the company focuses on the production of advanced CAR-T therapies in collaboration with Johnson & Johnson.