Maintains a robust quality management program for the Cell Therapies Facility (CTF) at Moffitt Cancer Center. At minimum, this will include 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. The incumbent will be expected to be an active participant in strategic planning on operations of the CTF.
Master's degree - REQUIRED (Biomedical sciences, biomedical engineering or bio-statistics)
PhD - PREFERRED (Biomedical sciences, biomedical engineering or bio-statistics)
MD in lieu of PhD is also a preference. Must have documented education or equivalent experience in the area of quality mgmt, minimally including a working familiarity with ISO9001.
ASQ Certification or equivalent - REQUIRED
CQE from American Society of Quality or equivalent (preferred) - Employee has up to one (1) from hire date to obtain the certification.
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
Minimum of 3 years related experience
Internal Number: 28984
About Moffitt Cancer Center
Cancer operates on fear. But cancer has one fear of its own: courage. At Moffitt Cancer Center we see that courage every day in our patients.
It’s why we’re every bit as relentless. Advancing personalized medicine and using predictive modeling to anticipate—and change—a tumor’s path. And exploring genomics, immunotherapy and more. Moffitt Cancer Center is at the very forefront of cancer centers worldwide in pioneering advances like CAR T-cell therapy, a promising approach to immunotherapy that uses a patient’s own immune cells to recognize and attack their tumors. Giving hope to patients with previously untreatable types of cancers.
At Moffitt, we want better treatments and more options. We won’t stop working to give everyone the options they need to #BeCourageous in the face of cancer.