Cell Therapy Quality Management Director – Moffitt Medical Group

Based in the Cell Therapy Quality Program, the Cell Therapy Quality Management Director maintains a robust quality management program for the Cell Therapies Facility (CTF) at Moffitt Cancer Center. 

This includes at minimum an identification and monitoring of critical quality metrics, oversight of all aspects of the quality program; including monitoring, audits, document control, process control, change control, facility and equipment control, personnel control, deviation control, records management, and routine reporting to senior management, and all required external regulatory and accreditation agencies.  In addition, this position is expected to be an active participant in strategic planning on CTF operations. 

Key Duties & Responsibilities

• Extract quality metric data from batch process records and other records and analyze as quality monitors
• Actively participate in design and implementation of master process records, review of resultant batch process records
• Examine reports of deviations, non-conformances, complaints and adverse events, extrapolate critical information and apply to tracking and trending analysis
• Create validation plans and evaluate success thereof
• Communicate clearly, both verbally and in writing, staff assignments, quality reporting, resource requirements and utilization, problems and prospective solutions
• Read and analyze reports, graphs, spreadsheets and other forms of data and integrate the information contained therein to facilitate performance of job functions
• Day-to-day staff supervision of a dedicated group of cell therapy quality assurance team members

Requirements

• Master's degree at minimum in Biomedical Sciences, Biomedical Engineering, Bio-statistics or a related field
• Note: Ph.D. (or MD in lieu of Ph.D.) is a preference; documented education or equivalent experience in the area of quality management, minimally including a working familiarity with ISO9001
• ASQ certification or equivalent, obtained up to one (1) year from date of hire
• *CQE from American Society of Quality or equivalent preferred
• Related work experience in a quality management capacity
• Experience in production of biologic type pharmaceuticals, preferably cell or gene therapy products
• Work with quality measure statistics, and with relational databases such as Oracle or SQL-server
• Demonstrated strong computer skills for working with information contained in relational databases
• 5 years of cellular therapy or quality experience preferred
• 3 years of supervisory, management or director level people leader experience preferred