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Manager, Stem Cell Transplant Quality

Stem Cell Transplantation 405100
129622 Requisition #
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The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report’s 2018 rankings. It is one of  the nation's original three comprehensive cancer centers designated by the National Cancer Institute.                                                              

The Manager, Stem Cell Transplant Quality position for the Department of Stem Cell Transplantation and Cellular Therapy (SCTCT) is responsible for the program quality oversight.  The oversight includes ensuring all components of the program are in compliance with respective regulatory/accreditation agencies, FDA, CMS, JC, and FACT. The position will manage all related documents, including SOPS, emergency plans, sustainable plans, and respective organizational charts. In collaboration with the senior management team develop strategic opportunities to improve and optimize the SCTCT informatics systems in alignment with industry good practice, across the scope of the program. This position is responsible for the overall understanding of all clinical procedures performed in the clinical areas including inpatient, outpatient, apheresis, and provider services for patients.  The position will work with the internal IT group to enhance the development of systems to support those processes while overseeing related staff. Act as primary liaison for SCTCT systems and ensure ongoing compliance for all regulatory bodies.  Participate nationally and internationally in the SCTCT arena to establish standards for all aspects of stem cell transplantation and cellular therapy.  Maintain international recognition and acceptance of the MD Anderson Stem Cell Transplantation and Cellular Therapy Program within the stem cell, cellular therapy and transplant arenas.


Operations Management

Compliance and Safety Oversight of the Program Facilities

Perform regular safety checks and safety trainings to include new staff and refresh senior staff at the Department of Stem Cell Transplantation and Cellular Therapy (SCTCT) in the Faculty Center.

Ensures Clinical areas (Inpatient and Outpatient) are following institutionally mandated emergency, disaster and business continuity plans.

Perform regular audits of the facilities to ensure areas are clean and organized meeting safety requirements. Collaborate with MD Anderson’s housekeeping department to ensure the facility is cleaned to appropriate standards by staff trained and competent.

Work with assigned areas, including Collections, Processing and Clinical areas, to ensure acceptable environmental conditions are maintained and documented, and all deviations from established limits investigated.  Collaborates with appropriate MD Anderson departments, such as Facilities and Physical Plant. 

Responsible for review and maintenance of the Clinical Quality Management Plan and monitoring of outcome parameters such as patient outcomes, contaminated products, graft failure, infection control, and other indicators as necessary.

Moderates the Quarterly Quality Management Program meetings with presentations from Data Management, Outpatient and Inpatient Clinical Care, Cell Therapy Laboratory, Cord Blood Bank, Infection Control and others to review their representative data.

Ensure training, qualification and competency of faculty and staff is completed by gathering appropriate documentation from credentialing and other educational sources, as required by regulatory agencies and accreditation organizations.

Management of SCTCT Program Quality Standards and Change Control oversight.

Responsible for SCTCT Clinical Document management including but not limited to the creation, implementation, revision, and archival of Guidelines of Care, SOPs, Policies, Plans of Care, Treatment Plans, Forms and Change Control.

Perform a wide range of audits throughout the SCTCT quality program to ensure regulatory and accreditation compliance with requirements and standards of practice.

Review and monitor performance indicator data relating to supplies, reagents and equipment to identify, develop and implement quality and process improvement.  Oversee validations of any related changes as documented in regularly scheduled audits.

Review and audit patient care and patient safety related equipment to ensure compliance with regulatory guidelines, including an evaluation of workflow and equipment.  Ensure all equipment is maintained in working order and that preventive maintenance is performed and documented by qualified/accredited/licensed entities and personnel.

Ensure policies, procedures, operational manuals and information documents, relating to supplies, reagents and equipment are written, maintained, reviewed and implemented.

Support and training of departmental staff to maintain consistency, efficiency and high quality standards.  Participate in the development, implementation and management of staff training, appraisal and competency ensuring regulatory compliance.

Manage and enforce compliance with safety guidelines, policies and procedures, according to applicable institution and state and federal agencies.

Review of SCTCT Department Data and Systems

Work closely with the SCTCT Informatics team to ensure their systems effectively meet the program’s operational needs, capture and review all data regarding the activities associated with the program, including patient outcomes, CIBMTR, ISBT 128, Collections, Processing and Clinical Practice, as required by FDA and FACT requirements.  Responsible for quality oversight of Informatics systems compliance with regulatory requirements and accreditation standards though routine process audits.

Works collaboratively with Data Management team, Informatics and other SCTCT sections in preparing Managed Care required documentation and submissions.

Works with the Informatics team to ensure all system validations related to data imports to SCTCT databases are conducted according to regulatory requirements and accreditation standards, in order to preserve and maintain data integrity.  This includes but is not limited to software/system upgrades or enhancements.

Customer Service / Communication / Personal Development

Participate in regular meetings with senior management team coordinating and communicating effectively with peers and others to accomplish goals and ensure maximum coordination of efforts.

Provide timely communication of relevant information to SCTCT personnel and maintain communication between activities.

Must have outstanding interpersonal communication and customer service skills, excellent verbal communication skills, excellent organizational skills, attention to detail and good writing skills.

Manage interactions with providers of services for SCTCT, both internal and external to MDACC

Utilize numerous communication strategies to ensure effective information exchange between the department, the division and the institution and relevant external companies/laboratories providing support/services relating to this position’s responsibilities.

Promote stem cell transplantation and cellular therapy quality program principles, increasing awareness within the transplant community and potential donor populations

Provide SCTCT program-related information regarding stem cell transplantation and cellular therapy to medical and scientific staff, internal and external to MDACC. Provide training and educational programs for national and international visitors.  Serve as quality systems resource for internal and external customers.

Perform other related duties as assigned.

Required: Bachelor's degree in a related biological field.
Preferred: Master’s degree in business or a healthcare related field.

Required: Seven years experience in the manufacturing of human hematopoietic stem cells for clinical use to include five years of management experience.

Preferred: Five years experience in the development and management of information systems related to hematopoietic stem cell processing for clinical use. Knowledge of Good Laboratory Practice, Good Manufacturing Practice, and experience of working in a highly regulated environment.

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html

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