Job 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

Benefits Overview

UT Health San Antonio offers an excellent benefits package for its employees. Employees who work at least 20 hours a week, with an appointment of at least 4.5 months, are eligible for 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 to the plan through payroll deduction. Employees and their dependents can also receive discounted copays and coinsurance when using UT Health Physicians, a network of 800 premier physicians including more than 100 specialists. 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 employee and dependent coverage for both at group rates.

Dental - Three dental insurance plan options are available for employees and their families through Delta Dental Insurance Company, two PPOs and one dental HMO plan. Both PPO plans allow employees to choose any licensed dentist.

Vision - Fully insured Vision Care benefits are offered by Superior Vision Services. Two vision plan options that offer either standard or enhanced vision benefits.

Disability - Employees can enroll in the Disability Insurance which provides income if a non-work related illness or injury prevents you from working.

FSAs - Employees can enroll in flexible spending accounts (FSAs) to set aside money from earnings before taxes for qualifying dependent day care expenses or out-of-pocket health care expenses.

Retirement - Employees are eligible for either the Teacher Retirement System (TRS) or the Optional Retirement Plan (ORP). TRS is a defined benefit retirement plan which UT Health matches employee contributions. ORP is for eligible faculty staff employees. Voluntary retirement programs are also available to invest before- or after-tax dollars with the choice of five quality retirement plan providers.

Time Off - A generous leave program offers multiple paid leave options:

• Front-loaded Paid Time Off: 128 to 208 hours (16 to 26 days) of Paid Time Off based on years of service, given at the start of each fiscal year. PTO may be prorated in year one based on date of hire.
• Extended Illness Bank: 8 hours (1 day) accrued per month which can be used for illness or injury after one day of Paid Time Off is taken.
• 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 a range of discounts on services, tickets, and gym membership.