Quality Manager, Stem Cell Transplant and Cellular Therapy

UT Health San Antonio•San Antonio, TX

16h

About The Position

The SCTCT Quality Manager is responsible for the development, maintenance, and ongoing activities of the clinical, collections, and laboratory quality programs of the UT Health San Antonio (UTHSA) Stem Cell Transplant and Cellular Therapy (SCTCT) Program. The Quality Manager ensures compliance with all aspects of the SCTCT Program Quality Plan, including requirements, policies, procedures, and practices related to accreditation standards and regulated products for both standard of care and clinical research. This encompasses quality management of adult clinical programs, the apheresis collections facility, and the clinical hematopoietic cell processing laboratory, in conjunction with the laboratory quality team. The Program's Quality Management Plan aims to facilitate high-quality clinical care for adult recipients and donors through audits, assessments, reporting of process and outcome measures, quality improvement activities, and investigations including corrective actions and root cause analysis. Additionally, it ensures all products released by the clinical hematopoietic cell processing laboratory comply with FACT standards and applicable FDA regulations, including good tissue practices and good manufacturing practices.

Requirements

Experience applying quality management/performance and customer service approaches.
In-depth knowledge of quality regulations within the health care and specifically, cellular therapy environment.
Demonstrated ability to establish, implement, and audit quality systems.
Expertise, skills, and knowledge of stem cell transplantation, apheresis, cellular processing, hematology/oncology, and cellular therapy clinical activities.
In-depth knowledge of FACT and American Association of Blood Banks (AABB) accreditation standards.
Ability to work collaboratively across UTHSA entities and disciplines.
Demonstrated commitment to patient- and family-centered care.
Effective analytical ability to develop and analyze options, recommend solutions, and solve complex problems and issues.
Effective organizational, planning, and project management abilities.
Ability to function independently and deal with multiple, simultaneous projects.
Ability to recognize personal strengths and weaknesses and develop goals for professional growth and achievement.
Ability to demonstrate a commitment to quality and excellence.
Thorough knowledge of QA best practices, tools, and techniques.
Detail-oriented, with proven ability to effectively manage time, see projects through to completion, organize competing priorities, and effectively address complex, urgent issues as they arise.
Strong interpersonal skills for collaborating effectively with a broad range of clinical and technical staff and representatives of external regulatory agencies.
Bachelor's degree in a related field required.

Nice To Haves

Master's degree preferred.

Responsibilities

Implementation and maintenance of the Quality Plan in the clinical setting, within the clinical transplant setting, apheresis, and cell processing environment, to support the collections, manufacturing, testing, and release of clinical and investigational cell therapy products.
Preparation of quarterly quality reports and presentation of updates to all staff within the SCTCT Program.
Oversight of data submission management to the Center for International Blood and Marrow Transplant Research (CIBMTR).
Close monitoring of patient safety and experience metrics and development of process improvement strategies to ensure the delivery of high-quality care.
Ensuring clearly defined quality objectives and functional responsibilities are in place according to SOPs and policies.
Responsibility for the document control system and program records management, including maintenance of SOPs and policies.
Ensuring document change control and periodic review are facilitated and implemented in a timely manner.
Creation and maintenance of patient outcomes reporting.
Implementation and maintenance of required training programs and education materials to incorporate evidence-based practice into program development.
Delivery of training to SCTCT administrative, clinical, and technical staff as needed.
Development and maintenance of patient education materials for the SCTCT program.
Auditing production, facility, and validation data, documents, logbooks, and other records for completeness, correctness, and external compliance audits.
Performing periodic reviews and audits of clinical program activities to ensure continued compliance with all written SOPs and policies.
Ensuring the SCTCT Program is in a constant state of survey-readiness.
Ensuring deviations are documented and investigated, and corrective and preventive actions are initiated, completed, and effective.
Providing assistance to clinical investigators with FDA and IRB application submissions and query responses.
Participation in regulatory and accreditation agency inspections.
Development of education materials to incorporate evidence-based practice into program development and delivery of training to SCTCT Program staff.
Development and maintenance of patient education materials for the SCTCT Program.
Collaboration with peers at other national cellular therapy programs to remain up-to-date on new policies and practices to improve patient outcomes.