This position is a member of the Stem Cell Transplant Program with accountability for programmatic quality oversight
as directed, inclusive of the Apheresis unit, to ensure compliance with all applicable regulatory agencies (FDA,
FACT, AABB, etc.). The incumbent is responsible for coordinating all quality activities in Apheresis to support the
Adult and Pediatric Hematopoietic Stem Cell Transplant and Immune Effector Cell Therapy Programs, as well
as all clinical trials involving investigational cell therapy products. Responsible for all quality aspects in cellular
products manufacturing (collection, labeling, storage, transporting, release/dispensing) to support the Stem
Cell Transplant Program and clinical trials (INDs) conducted at YNHH. It also includes analysis of quality and
performance improvement including 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 the unit manager and staff in these areas to assure compliance with the
Foundation for the Accreditation of Cellular Therapy (FACT) standards and other quality measures identified by
program leadership. Education to promote regulatory readiness and ongoing accreditation compliance.
1. Develops, revises and maintains the quality management plan for the Apheresis unit, integrating with
the quality management plans for the other Stem Cell Transplant program components .
2. Reviews and is knowledgeable about all applicable regulations of the FDA, FACT, AABB, CAP, CLIA,
TJC, State of Connecticut and other relevant agencies. Monitors all new regulations and ensures that
processes and procedures comply with requirements.
3. Ensures that the Apheresis unit is prepared for regulatory site visits and other external audits. Maintains
associated applications, checklists, and other documents related to regulatory/ accreditation compliance.
4. Serves as a resource and consultant for quality activities to the clinical program and marrow collections staff
5. Facilitates the coordination of multidisciplinary efforts in regard to regulatory readiness. Provides leadership
in meeting goals and objectives.
6. Prepares periodic reports regarding quality activities, and presents as needed on the status of the quality
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.
8. Reviews Event and Variance/Deviation reports from Apheresis; makes recommendations for corrective and
preventive actions and tracks and trends events. Reports Biological Product Deviations to FDA as required.
9. Maintains the Document Control system for Apheresis.
10. Reviews all SOPs, policies, change controls, corrective and preventative action plans, and
11. Reviews and approves training materials and competency assessments to ensure that all personnel have
been trained and are competent in any new or revised procedure that apply to their duties and training /
competency is documented.
12. Qualifies and approves suppliers of critical equipment, supplies and services.
13. Creates, reviews and implements validation plans to ensure compliance with all applicable regulations.
14. In conjunction with Medical Director and Facility Director communicates with study principal
investigators, IRB & FDA.
15. As necessary, facilitates and coordinates projects to improve processes in Apheresis. Interacts with
directors, managers, and staff in relation to projects.
16. Keeps abreast of recent developments in the Apheresis and Cellular Therapy field.
17. Performs other job duties as required
EDUCATION (number of years and type required to perform the position duties):
Bachelor's degree in a healthcare specialty (e.g., Nursing, Allied Health) required
EXPERIENCE (number of years and type required to meet an acceptable level of performance):
One to three years experience in a healthcare specialty required; experience in apheresis, cell therapy/ stem cell
transplantation, and/or regulatory compliance/quality assurance preferred.
Excellent organizational, verbal and written communication skills, as well as presentation skills required. Must be
proficient in the use of Microsoft Word , Powerpoint and Excel.
ACCOUNTABILITY (how this position is held accountable for such as goals achievement, budget adherence, or
other areas of accountability):
Direct report to Quality Manager, Stem Cell Transplant Program
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).
RN, Clinical Laboratory Specialist, or Medical Technologist (ASCP) preferred.