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 has responsibility and accountability for overall quality oversight for the Cell Therapy Processing and Advanced Cell Therapy Laboratories 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., , FDA, FACT, NMDP, AABB, etc.). The incumbent is responsible for coordinating all cell therapy laboratory quality activities to support the Adult and Pediatric Hematopoietic Stem Cell Transplant and Immune Effector Cell Therapy Programs, as well as clinical trials involving investigational cell therapy products. The position is responsible for all quality aspects in cellular products manufacturing (processing, 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 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 the Quality Manager of the Stem Cell Transplant Program 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 on regulatory/accreditation requirements to promote readiness and ongoing compliance.
Responsibilities: 1. Develops, revises and maintains the quality management plan for the Cell Therapy Laboratories, integrating the with the quality management plans for the clinical program and collection activities. 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 Cell Therapy Laboratories 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 all members of the Cell Therapy Laboratories, and to the clinical program and apheresis and marrow collections staff as needed. 5. 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. 6. Prepares periodic reports regarding quality activities, and presents to management at least quarterly 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. Processes/reviews Event and Variance/Deviation reports from the Cell Therapy Laboratories; 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 the Cell Therapy Laboratories 10. In conjunction with Facility Director reviews manufacturing batch records and authorizes release of investigational products for distribution/administration. 11. Reviews and approves training materials and competency assessments. Ensures 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. Reviews validation plans to ensure compliance with all applicable regulations. 13. Reviews all SOPs, policies, change controls, corrective and preventative action plans, engraftment/outcome data. 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 the Cell Therapy Laboratories. Interacts with directors, managers, and staff in relation to projects. 16. Keeps abreast of recent developments in the Cellular Therapy field. Participates in professional development programs. 17. Performs other job related duties as required.
Bachelor's Degree in Medical Laboratory Science or other Science required; Masters Degree preferred.
Three (3) to five (5) years' experience in a clinical regulatory environment or related quality/regulatory experience required. More than 3 years of experience in cell therapy GMP/GTP is highly preferred.
MLS(ASCP) or equivalent certification preferred
Excellent organizational, verbal and written communication skills, as well as presentation skills required. Must be able to collaborate effectively with all levels of management. Must be proficient in the use of Microsoft Word, Powerpoint and Excel.
Ensures regulatory readiness for all relevant regulatory/ accrediting agencies in the Cell Therapy Laboratories.
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. Develops, implements, and monitors the quality management program.