Cellular Therapy Quality Manager

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New Haven, CT
Jan 6, 2021

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Job Description

Overview

To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and professionals, every day.

This position reports to the Program Director of the Stem Cell Transplant Program and the Cellular Therapy Program
Manager. This position has responsibility and accountability for coordinating, planning and maintaining overall
quality management for the Adult and Pediatric Stem Cell Transplant Program at Yale New Haven Hospital, as well
as for improving key processes, policies and procedures as they relate to regulatory compliance with all applicable
agencies (e.g., FACT, FDA, NMDP, AABB, TJC, CMS, etc.). The incumbent is responsible for coordinating all
quality activities for the Adult and Pediatric Hematopoietic Stem Cell Transplant Program, including CIBMTR, NMDP,
requests for QA data from insurance companies and all hospital and program related internal quality initiatives. The
position is responsible for the analysis of quality and performance improvement including responsibilities for
coordination and collection of data, analysis and trending of required regulatory indicators (internal and external),
process measures and clinical outcomes measures. This position interacts closely with Apheresis and the
Collection and Cell Therapy Laboratory to assure compliance with the Foundation for the Accreditation of Cellular
Therapy (FACT) standards and other quality measures identified by program leadership. This position also serves to
educate staff and physicians throughout the system on regulatory /accrediting requirements to promote readiness
and ongoing compliance. This position is also responsible for integrating new cellular therapy products (CAR-T, TIL,
TCR) into our current SOPs. In this capacity, the BMT Quality Manager is expected to develop and maintain
professional affiliations to keep abreast of the regulatory requirements for Hematopoietic Stem Cell Transplantation in
both the outpatient and inpatient hospital settings.

EEO/AA/Disability/Veteran

Responsibilities

  • 1. Develops, revises and maintains a quality management plan for the Adult and Pediatric Stem Cell Transplant Program, integrating the clinical program with the quality management plans for collection and processing activities.
  • 2. Serves as a resource and consultant for quality activities to all members of the Program, including medical staff, nursing, transplant coordinators, data registry and others, such as apheresis, cell therapy processing laboratory, and blood bank.
  • 3. Facilitates the coordination of multidisciplinary efforts in regard to regulatory readiness (e.g. self-assessment, measurement of success data, corrective action plans). Provides leadership in meeting goals and objectives.
  • 4. Communicates among the clinical, collection and processing services to ensure that the entire program functions cohesively.
  • 5. Ensures that the Program is prepared for regulatory site visits and coordinates site visit logistics (hosts, escorts, scribes, etc.). Maintains associated applications, checklists, and other documents related to regulatory/ accreditation compliance.
  • 6. As necessary, leads, facilitates and coordinates projects to improve clinical and non-clinical areas with regard to the Program. Interacts with managers, staff, department heads, clinical service coordinators, vice presidents, and chiefs of respective departments in relation to projects.
  • 7. Conducts audits to ensure the quality management system is operating effectively; analyzes collected data, and coordinates multidisciplinary corrective action plans and quality improvement activities within the Program.
  • 8. Prepares periodic reports regarding quality activities, and presents to the Program's executive management at least quarterly on the status of the quality management system. Compiles and prepares the Program's Annual Report in conjunction with quality personnel from key support services.
  • 9. Coordinates Program's quality meetings including agendas, minutes and attendance logs.
  • 10. Facilitates educational activities related to the field of Cellular Therapy/Transplant/Quality to ensure that all areas receive continuing education
  • 11. Other projects, assignments and responsibilities as indicated.

Qualifications

EDUCATION (number of years and type required to perform the position duties):
Bachelor's degree required (nursing or other healthcare specialty related to Hematopoietic Stem Cell
Transplantation). RN or CLS or MT(ASCP) licensure/board certification required. Advanced degree (e.g., MBA,
MPH, MSN, or other Masters degree) in a health related field preferred (will consider applicants currently enrolled in
Masters program)
EXPERIENCE (number of years and type required to meet an acceptable level of performance):
Three (3) to five (5) years of progressive clinical or technical experience required with at least one (1) year in a
management/leadership role. Required three (3) to five (5) years of experience in healthcare with demonstrated
teaching experience, and process improvement with healthcare/ laboratory operations and experience with high level
analytical tools. Six-Sigma or other formal process improvement training preferred. Experience and knowledge of
FACT/AABB standards and survey accreditation process preferred.
SPECIAL SKILLS:
Proven analytical/problem-solving skills. Outstanding communication, presentation and facilitation skills. Strong
computer skills (e.g., Microsoft PP and Excel) and demonstrated ability to successfully lead process change are
needed. Strong management skills and communication skills and very strong planning skills are required.
ACCOUNTABILITY (how this position is held accountable for such as goals achievement, budget adherence, or
other areas of accountability):
This position works to coordinate, plan and support overall quality management and regulatory compliance for the
Adult and Pediatric Stem Cell Transplant Program (Clinical, Collections and Processing activities) at Yale-New
Haven Hospital, as well as to help to improve key processes, policies and procedures as they relate to accreditation ,
safety and regulatory readiness.
COMPLEXITY (describe planning, problem solving, decision making, creative activity, or other special factors
inherent in the responsibilities of this position):
In personal and job-related decisions and actions, consistently demonstrates the values of integrity (doing the right
thing), patient-centered (putting patients and families first), respect (valuing all people and embracing all differences),
accountability (being responsible and taking action), and compassion (being empathetic).
Creates, plans and develops guidelines for organizing ideas, implementing strategies, harmonizing and coordinating
elements essential to achieving regulatory readiness. Possesses an excellent knowledge of Cellular Therapy
regulations/ standards and performance improvement principles and how they relate to daily management decisions ,
strategic planning, operational decisions and organizational change. The position works across multiple disciplines
and departments with broad authority and responsibility for process improvement and performance.
LICENSURE/CERTIFICATION:
Will vary depending on clinical specialty

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Job Info

Job: 23705

Department: BMT Program
Category: MGMT/LEADERSHIP
Sub Category: 1ST LEVEL MGR (MGR/SUP)
Status: Full Time Benefits Eligible
Shift: DAYS
Hours: 40

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