Quality Manager, Stem Cell Transplant and Cellular Therapy

Description
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: the requirements, policies, procedures and practices as they relate to accreditation standards and regulated products administered for both standard of care and clinical research purposes. This includes quality management of the adult clinical programs, apheresis collections facility, and the clinical hematopoietic cell processing laboratory, in conjunction with the laboratory quality team.

The Program's Quality Management Plan facilitates high quality clinical care for adult recipients and donors, through audits, assessments and reporting of process and outcome measures, quality improvement activities, and investigations including corrective actions and root cause analysis.

All products released for the clinical hematopoietic cell processing laboratory comply with the Foundation for the Accreditations of Cellular Therapy (FACT) standards and applicable FDA regulations including good tissue practices and good manufacturing practices.

Responsibilities

• Responsible for the 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.
• Prepares quarterly quality reports and present updates to all the staff within the SCTCT Program.
• Oversees the management of data submission to the Center for International Blood and Marrow Transplant Research (CIBMTR).
• Closely monitors patient safety and experience metrics and develops process improvement strategies to ensure the delivery of high-quality care.
• Ensures that clearly defined quality objectives and functional responsibilities are in place according to SOPs and policies.
• Responsible for the document control system and program records management, including maintenance of SOPs and policies.
• Ensures document change control and periodic review are facilitated and implemented in a timely manner. Responsible for creating and maintaining patient outcomes reporting.
• Implements and maintains the required training programs and education materials to incorporate evidence-based practice into the program development
• Delivers training to SCTCT administrative, clinical, and technical staff as needed.
• Develops and maintains patient education materials for the SCTCT program.
• Audits production, facility and validation data, documents, logbooks and other records for completeness, correctness, and external compliance audits.
• Performs periodic reviews and audits of clinical program activities to ensure continued compliance with all written SOPs and policies.
• Ensure the SCTCT Program is in a constant state of survey-readiness.
• Ensure deviations are documented and investigated, and corrective and preventive actions are initiated, completed, and effective.
• Provides assistance to clinical investigators with the FDA and IRB application submissions and query responses.
• Participates in regulatory and accreditation agency inspections.
• Develops education materials to incorporate evidence-based practice into program development and delivers training to SCTCT Program staff.
• Develops and maintains patient education materials for the SCTCT Program.
• Collaborates with peers at other national cellular therapy programs to remain up to date on new policies and practices to improve patient outcomes.

Qualifications

• 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.

Education:

• Bachelor's degree in a related field required 
• Master's degree preferred