Quality Manager, Stem Cell Transplant and Cellular Therapy

About the role

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 role oversees quality management of the adult clinical programs, apheresis collections facility, and the clinical hematopoietic cell processing laboratory, in collaboration with the laboratory quality team. The Program's Quality Management Plan facilitates 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.

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

Responsibilities

• Implement and maintain the Quality Plan in the clinical setting, within the clinical transplant setting, apheresis, and cell processing environment to support collections, manufacturing, testing, and release of clinical and investigational cell therapy products.
• Prepare quarterly quality reports and present updates to all staff within the SCTCT Program.
• Oversee the management of data submission to the Center for International Blood and Marrow Transplant Research (CIBMTR).
• Monitor patient safety and experience metrics and develop process improvement strategies to ensure high-quality care delivery.
• Ensure clearly defined quality objectives and functional responsibilities are in place according to SOPs and policies.
• Maintain the document control system and program records management, including SOPs and policies.
• Facilitate and implement document change control and periodic review in a timely manner.
• Create and maintain patient outcomes reporting.
• Implement and maintain required training programs and education materials to incorporate evidence-based practice into program development.
• Deliver training to SCTCT administrative, clinical, and technical staff as needed.
• Develop and maintain patient education materials for the SCTCT program.
• Audit production, facility, validation data, documents, logbooks, and other records for completeness, correctness, and external compliance audits.
• Perform 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.
• Document and investigate deviations, and initiate, complete, and verify corrective and preventive actions.
• Assist clinical investigators with FDA and IRB application submissions and query responses.
• Participate in regulatory and accreditation agency inspections.
• Collaborate with peers at other national cellular therapy programs to remain current on new policies and practices to improve patient outcomes.

Requirements

• Bachelor’s degree in a related field (Master’s degree preferred).
• At least four (4) years of related experience.
• Experience applying quality management, performance, and customer service approaches.
• In-depth knowledge of quality regulations within healthcare, specifically in the cellular therapy environment.
• Demonstrated ability to establish, implement, and audit quality systems.
• Expertise in 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.
• Strong organizational, planning, and project management abilities.
• Ability to function independently and manage multiple, simultaneous projects.
• Ability to recognize personal strengths and weaknesses and develop goals for professional growth.
• Commitment to quality and excellence.
• Thorough knowledge of QA best practices, tools, and techniques.
• Detail-oriented with proven ability to manage time, prioritize tasks, and address complex issues effectively.
• Strong interpersonal skills for collaborating with clinical and technical staff and external regulatory agencies.

About Us

The University of Texas at San Antonio (UT San Antonio) is a nationally recognized, top-tier public research university that unites the power of higher education, biomedical discovery, and healthcare within one visionary institution. As the third-largest research university in Texas and a Carnegie R1-designated institution, UT San Antonio advances knowledge, social mobility, and public health across South Texas and beyond.

UT San Antonio serves approximately 42,000 students in 320 academic programs spanning science, engineering, medicine, health, liberal arts, AI, cybersecurity, business, education, and more. With 17,000 faculty and staff, UT San Antonio has been recognized by Forbes as one of America’s Best Employers for Company Culture.

Benefits

• Medical: UT SELECT Medical insurance is offered free for employees and administered by Blue Cross and Blue Shield of Texas. Family members can be added through payroll deduction. Employees and dependents receive discounted copays and coinsurance when using UT Health Physicians.
• Life Insurance: Employees receive $50,000 of group term life insurance and $50,000 of basic accidental death and dismemberment insurance for free, with options to purchase additional coverage.
• Dental: Three dental insurance plan options (two PPOs and one HMO) are available through Delta Dental Insurance Company.
• Vision: Fully insured vision care benefits are offered by Superior Vision Services, with two plan options (standard or enhanced).
• Disability: Employees can enroll in disability insurance to provide income if a non-work-related illness or injury prevents them from working.
• Flexible Spending Accounts (FSAs): Employees can set aside pre-tax earnings for qualifying dependent daycare or out-of-pocket healthcare expenses.
• Retirement: Employees are eligible for either the Teacher Retirement System (TRS) or the Optional Retirement Plan (ORP). Voluntary retirement programs are also available.
• Time Off:
  • Paid Time Off (PTO): 128 to 208 hours (16 to 26 days) front-loaded at the start of each fiscal year, prorated in the first year based on hire date.
  • Extended Illness Bank: 8 hours (1 day) accrued per month for illness or injury after one day of PTO is used.
  • Paid Family Leave: Up to 240 hours (6 weeks) to care for a spouse, child, or parent after 6 months of consecutive employment.
  • Holidays: 12 set paid holidays each year.
• Discounts: Employees enjoy discounts on services, tickets, and gym memberships.