Director of Quality

Job Overview:

I’m seeking an experienced Quality Director for an innovative cell therapy client. This pivotal role involves leading the Quality Management program ensuring compliance with FDA regulations & supporting new product launches.

Job Responsibilities:

• You will be responsible for ensuring compliance with FDA cGMP and cGTP regulations.
• The Quality Director will participate in the design and implementation of master process records & review of resultant batch process records
• You will oversee audits, document control, process control & coordinate quality agreements with external partners.
• You will be responsible for contributing to Drug Master Files (DMF) and IND applications to the FDA.
• Responsible for investigating deviations and non-conformances.

Job Requirements:

• Master’s degree in Science or related field with 5+ year’s experience in quality management
• You should have strong working knowledge of quality metrics and relational databases like Master Control.
• As the Quality Director you should have previous track-record with product launches and supporting health authority inspections
• Knowledge of regulatory requirements for cell and gene therapy products and clinical trials.