Director, QA Operations - Cell Therapy

Legend Biotech USA; Raritan (NJ); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Legend Biotech USA is seeking a Director of QA Operations in Raritan, NJ to lead quality oversight of cell therapy manufacturing in a strict cGMP setting. You will supervise disposition activities, batch review, QC lab oversight, and drive continuous improvement across QA operations.

The role requires extensive leadership experience, deep knowledge of regulatory requirements, and a passion for process excellence in a fast-paced manufacturing environment.

Qualifications

• Bachelor's Degree in Science or equivalent technical discipline.
• Minimum 14 years relevant work experience in aseptic manufacturing or QA.
• Knowledge of cGMP regulations and FDA/EU guidance for cell-based products.
• Strong leadership and written/oral communication skills.
• Experience with quality systems and continuous improvement.
• Proficiency with Microsoft Office applications (Outlook, Excel, Word, PowerPoint).

Responsabilités

• Manage daily quality activities to ensure cGMP compliance.
• Oversee disposition of incoming materials and final drug product.
• QA shop floor oversight of manufacturing operations.
• Lead batch record review activities for the site.
• Provide quality oversight of the QC laboratory.
• Develop and implement long-term quality programs and CI initiatives.
• Manage a team of senior managers and professionals; hire and develop staff.

Connaissances

People leadership

Quality systems

cGMP compliance

Communication skills

Process improvement

Formation

Bachelor's degree in Science or equivalent

Outils

MS Office

Description du poste

Legend Biotech USA is seeking a Director of QA Operations in Raritan, NJ to lead quality oversight of cell therapy manufacturing in a strict cGMP setting. You will supervise disposition activities, batch review, QC lab oversight, and drive continuous improvement across QA operations.

The role requires extensive leadership experience, deep knowledge of regulatory requirements, and a passion for process excellence in a fast-paced manufacturing environment.