Cellular Therapy Quality Coordinator Smilow - Yale New Haven Health

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 is a member of the Cell Therapy Program with accountability for programmatic quality oversight as directed, inclusive of the apheresis unit, clinical programs (adult and pediatric) for stem cell transplant (SCT) and Immune Effector Cells (IEC), and marrow and tumor collection program to ensure compliance with all applicable regulatory agencies (FDA, FACT, AABB, etc.). The incumbent is responsible for coordinating all quality activities 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 (and Immune Effector Cells Programs 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 Cell Therapy Program Manager and Quality manager, Cellular Therapy Lab unit managers 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. The position reports to the Cell Therapy Quality Manager. Education to promote regulatory readiness and ongoing accreditation compliance.EEO/AA/Disability/Veteran.

EEO/AA/Disability/VeteranResponsibilities:

• 1. Develops, revises and maintains the quality management plan for each accredited program within the cell therapy program.
• 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. 3.Ensures that the Clinical Programs, Marrow and Tumor Collection, and Apheresis unit are 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, apheresis, and marrow collections
• 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 management system.
• 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 and clinical program; 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, Stem Cell Transplant, and Cell Therapy programs.
• 10. Reviews all SOPs, policies, change controls, corrective and preventative action plans, and engraftment/outcome data.
• 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 Directors and Facility Directors communicates with study principal investigators, IRB & FDA.
• 15. As necessary, facilitates and coordinates projects to improve processes. Interacts with directors, managers, and staff in relation to projects.
• 16. 16.Keeps abreast of recent developments in the Stem Cell Transplant and Cellular Therapy fields, including apheresis and immune effector cells.
• 17. Performs other job duties as required

Qualifications:

EDUCATION

Bachelor's degree in a healthcare specialty (e.g., Nursing, Allied Health) required

EXPERIENCE

One to three years experience in a healthcare specialty required; experience in apheresis, cell therapy/ stem cell transplantation, and/or regulatory compliance/quality assurance.

LICENSURE

RN, Clinical Laboratory Specialist, or Medical Technologist (ASCP) preferred.

SPECIAL SKILLS

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.