Cell Therapy Quality Manager

2 weeks ago

Tampa, United States Moffitt Cancer Center Full time
Position Highlights: 

Maintains a robust Quality Management (QM) program in concert with the Cell Therapies Facility (CTF)Technical Director, Scientific Director and Medical Director.  The QM Director will maintain compliance with standards of the Foundation for Accreditation of Cellular Therapy (FACT), the College of American Pathologists (CAP), as well as provisions of FDA current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP). In addition, the QM Director will coordinate quality agreements with internal and external sponsors of cell therapy development and manufacturing for experimental clinical trials. At minimum, this will include identification, monitoring and trending of critical quality metrics, audits, document control, process control, change control, facility and equipment control, personnel control, deviation control and records management. The QM Director is responsible for routine reporting to senior leadership and all required external regulatory and accreditation agencies. The incumbent will be expected to participate in creation of the Chemistry, Manufacturing and Control (CMC) module of Investigational New Drug (IND) applications to the FDA.  The QM Director will be an active participant in strategic planning on operations of the CTF at Moffitt Cancer Center. 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.
Credentials and Experience: 
  • Master’s degree in Science, Biology Quality or related field required.
  • 3 years work experience in a quality management capacity.
  • 3 years experience in production of biologic type pharmaceuticals, preferably cell or gene therapy products.
  • 3 years experience working with quality measure statistics and with relational databases such as Master Control.
  •  One of the following ASQ Certifications: CMQ/OE Certified Manager of Quality/Organizational Excellence, CQA Certified Quality Auditor, CQE Certified Quality Engineer, CRE Certified Reliability Engineer, CSSBB Certified Six Sigma Black Belt. 
  • *Must obtain within One year from DOH

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