Director of Quality Cell Therapy and Transplant at the Hospital of the University of Pennsylvania

Summary:

• The Director of Qualitywill develop, maintain and evaluate Penn Medicine quality processes in support of the Cell Therapy and Transplant program (CTT) including quality database(s), standard operating procedures, policies/procedures, and paper/electronic systems. The position will partner across our Penn Medicine CTT entities to develop robust Quality Management and Oversight programs and to coordinate ongoing accreditation reviews and inspections from transplant regulatory bodies such as: FACT, JCAHO, etc. The accreditation and quality review will be conducted in collaboration with local CTT Quality Coordinators, and results, learnings, and best practices will be shared across all sites.. The position will also support/oversee external quality audits across the local sites to insure compliance with quality policies, procedures, label indications,and appropriate clinical care. The position will serve as a systematic resource in the interpretation of regulatory and accreditation standards, as well as the development of systems/processes to ensure compliance. Assumes leadership role, and works with local Quality Coordinators, in facilitating activities of preparation for and performance of surveys by FACT, JCAHO, and other accrediting bodies. In addition, this position will ensure that each CTT program is compliant with all governing bodies that determine transplant quality such as FACT or CIBMTR. The Quality Director will work with multidisciplinary and inter-entity stakeholders to develop tools and establish baseline quality performance and outcomes across all participating CTT locations, andthe Director will partner with the CTT Director of Operations to adopt best practices across the health system. This position will interface/interact with outside entities, such as NMDP, CIBMTR, Pharma, ASTCT, etc. to ensure that the program is developing to industry standards/accreditations. The Director of Quality reports directly to the Corporate Director of CTT and partners in the execution of strategic growth and regional expansion with the Director of the CTT program and the CSL. This includes chairing the CSL CTT Quality Committee; partnering with executive, clinical, and administrative leadership at all Penn Medicine hospitals to further the expansion and implementation of the CTT program; and managing external stakeholder activities in pursuit of Penn Medicine system solutions given current and future infrastructure. Implements safety, accreditation, and compliance programs that are aligned across Penn Medicine to achieve the highest levels of performance. Non-Oncology:Through this expanded scope, the Director will partner with the clinical and research physician leaders across a variety of Departments and Divisions that are exploring new and innovative cellular therapy programs. Such Departments and Divisions include Medicine, Neurology, Benign Hematology. This list of clinical and research collaborators continues to expand as the non-oncology cellular therapy industry rapidly grows. In addition, the Director will be responsible for interacting with relevant pharmaceutical companies and third party institutions to establish procedures, protocols, contracts, regulatory standards and process, and all other necessary services to initiate both clinical trials and clinical care across UPHS.