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 improving key processes, policies and procedures as they relate to regulatory compliance with all applicable agencies.
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.
Reviews 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.
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.
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.
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.
Prepares periodic reports regarding quality activities, and presents to management at least quarterly on the status of the quality management system.
Conducts audits to ensure the quality management system is operating effectively; analyzes collected data, and coordinates multidisciplinary corrective action plans and quality improvement activities.
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.
Maintains the Document Control System for the Cell Therapy Laboratories
In conjunction with Facility Director reviews manufacturing batch records and authorizes release of investigational products for distribution/administration.
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.
Reviews validation plans to ensure compliance with all applicable regulations.
Reviews all SOPs, policies, change controls, corrective and preventative action plans, and engraftment/outcome data.
In conjunction with Medical Director, and Facility Director communicates with study principal investigators, IRB, FDA.
Facilitates and coordinates projects to improve processes in the Cell Therapy Laboratories as necessary. Interacts with directors, managers, and staff in relation to projects.
Keeps abreast of recent developments in the Cellular Therapy field. Participates in professional development programs.
Bachelor's degree in medical laboratory science or other science; Master’s degree preferred.
MLS (ASCP) or equivalent certification preferred.
3 to 5 years' experience in a clinical regulatory environment or related quality/regulatory experience required. 3+ years of experience in cell therapy GMP/GTP is highly preferred.
Excellent organizational, verbal and written communication 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.
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.
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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.
Internal Number: 8931
About Yale New Haven Hospital
Yale New Haven Hospital is the destination for patients who need more than what ordinary hospitals can provide. As a Magnet recognized, tertiary medical center, with over 1,500 beds, we are one of the largest hospitals in the country, with two acute care campuses, and three emergency departments, including a Level I trauma center.