Quality Assurance Manager
Program in Children’s Regenerative Medicine
Department of Pediatric Surgery
The University of Texas Medical School at Houston
The newly established Program in Children’s Regenerative Medicine in the Department of Pediatric Surgery at The University of Texas Medical School at Houston is seeking a Quality Assurance Manager for its Human Cell Processing cGMP Facility. A specific interest and/or expertise in cell therapy is desired. This initiative will help to save children’s lives and improve the quality of their lives by developing techniques and therapies to repair damaged organs or birth defects in children.
The successful candidate will work within a human cell and tissue processing facility and will be responsible, under the guidance of the facility director, for all quality assurance and regulatory activities carried out within the facility. He/she will be expected to assure that all production and control operations are sufficiently specified, that current Good Manufacturing Practices (cGMP) or Good Tissue Practices (cGTP) are applied according to the type of manipulation and/or use of the biological product, and will assure documentation, control and efficiency of the quality management system. Among primary responsibilities, the selected candidate will be responsible for managing quality assurance activities in the areas of Standard Operating Procedures, training and education, competency evaluation, validation, deviations, change control, investigations and CAPA, equipment qualification, records management, lot release procedures and audits. The successful candidate will also be responsible for ordinary management of documents for submission to regulatory bodies, for the compliance to all North American regulations in the field of reference, and will keep updated on all future regulations, assuring constant compliance of the facility to the highest regulatory standards of reference as well as act as a liaison for regulatory issues between the clinical team and the cell and tissue processing facility.
The Program has over 5,000 square feet of state of the art, fully-equipped basic laboratory and tissue engineering facilities as well as 4,000 square feet of cGMP laboratories for production of clinical grade, cell and tissue engineered products.
Minimum Qualifications:
• Bachelor's degree with GMP and QA training and/or 5 years working in GMP environment
• Strong background in auditing/compliance and/or experience in dealing with regulatory agencies
• Detail oriented with demonstrated capacity to communicate and organize effectively
• Demonstrated computer literacy
• Fluent in English, both written and verbal
Preferred Qualifications:
• Previous experience in this position
• Previous lab experience in cell production facility and/or blood bank
• Medical Technologist licensure
Apply Online: http://jobs.uth.tmc.edu (Requisition #121406)
Learn more about us: utsurg.uth.tmc.edu/pedisurgery
The University of Texas Medical School at Houston is an Equal Opportunity Employer M/F/D/V (minority/female/disabled/veteran).
