Cellular Therapy Laboratory Quality and Accreditation Manager

Cellular Therapy Laboratory Quality And Accreditation Manager

The Cellular Therapy Laboratory (CTL) Quality and Accreditation Manager oversees quality assurance, quality improvement, and regulatory compliance activities for the facility, including cell processing, manufacturing, storage, testing, release, and distribution of cellular therapy products.

Under the joint direction of the CTL Director, CTL Facility Director, the Medical Directors, and the Sr. Director of the Cellular Therapy Program, the CTL Quality and Accreditation Manager is responsible for planning, implementing, performing, maintaining, and evaluating quality management activities within the scope of the laboratory to ensure the highest standards of product quality, patient safety, and regulatory compliance. This role supports continuous improvement across laboratory operations and ensures alignment with institutional, regulatory, and accreditation requirements.

The CTL Quality and Accreditation Manager is a lead for the team ensuring regulatory and accreditation compliance, including but not limited to FACT, FDA (cGTP/cGMP), and DNV, through the maintenance of Standard Operating Procedures (SOPs), ensuring robust auditing systems, ensuring review of the Quality Management Plan, document control systems, chart and batch record review processes, and other quality systems necessary to meet applicable standards.

The incumbent interprets regulatory requirements in a manner that effectively supports laboratory operations while promoting efficiency and continuous quality improvement.

This position requires timely completion of regulatory reporting, ensuring completion of staff training documentation, audit and inspection support from both internal and external bodies, and maintaining current knowledge of all relevant regulations, accreditation standards, and best practices governing cellular therapy laboratories.

Accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT) is required by national, regional, and local insurance providers for participation in cellular therapy and transplant networks.

Quality Program Management

• Establishes and maintains systems and procedures to monitor the quality of the areas under the scope of the position.
• Monitors quality assurance and performance improvement activities and guidelines; monitors quality assurance indicators and consults with the Director and Section Coordinator when indicators fall outside of acceptable limits.
• Communicates trends and opportunities for improvement to key process owners.
• Regularly compiles reports for presentations to quality committees.
• Prepares the NWMTP quality management reports for the BMT Program Cross Functional Quality Committee.
• Serves as liaison for the areas under the scope of this position to relevant quality committees.
• Participates in projects as assigned.
• Performs or assigns scheduled and unscheduled quality audits of processes, analyzes outcome, and process indicators for the CTL. Generates reports, reviews with leadership, management and other appropriate stakeholders, and makes recommendations based on results.
• Member of the accreditation readiness team for all surveys.
• Is familiar with FACT and FDA regulatory requirements
• Responsible for the development and maintenance of systems designed to comply with regulations.
• Prepares the CTL for inspections by regulatory and accrediting agencies, responds to inspection reports, and collaborates with the team to ensure the timely implementation of corrective measures.

Technical Review and Responsibilities

• Is responsible for the maintenance of the Document Control system, and implementation of the Managed Care Network (MCN) document system in the facility.
• Responsible for final chart and batch record review and will work with the CTL Director for occurrence and error corrections noted.
• Monitors quality control results, logs and activities on a day- to-day basis and ensures that appropriate action is taken when results are out of control. Alerts the Director to QC situations that cannot be readily corrected.
• Responsible for tracking, trending, and managing errors, accidents, and incidents.
• If requested by the CTL Director, will communicate new policies and procedures to lab employees and insures that required training is completed and documented.
• Reviews competency results, occurrence reports and RLDatix Risk & Safety reports with CTL Director and assists with all data trending and follow-up.
• Responsible for collaborating with the CTL Director to complete Validation and Verification Protocols.
• Collaborates with other departments when revisions to their policies/procedures are required and/or needed for accreditation requirements.
• Qualified and trained individuals can assist with benchwork; however, they will not be able to evaluate their own work. Evaluates any preventative actions needed to help decrease recurrence of trends, ensures implementation and documentation of any preventative action taken,…