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, and evaluates effectiveness of such actions.
• Assist with implementation and maintenance of clinical trial participation. 

Process Improvement Facilitation:

• Performs and provides leadership and oversight for topic- specific, continuous improvement activities, including internal and external: data collection, data review, reporting, problem identification, process improvement activities, and ongoing monitoring.
• Responsible for collaborating with the CTL Director on continuous process improvement projects.

Education / Training

• Maintains competency and professional standards of practice through participation in at least 10 hours of continuing education related to cellular therapy, cell processing, and quality management annually.
• Attends CTL staff meetings and participates in training programs.

• Bachelor’s degree in a healthcare-related field or relevant scientific field, or equivalent experience.
• 5 years of experience in quality assurance/management practices, quality control, and validation protocols

Job Related Knowledge, Skills and Abilities (Competencies):

• Attention to detail.
• Strong working knowledge of word processing and spreadsheet programs.
• Strong analytical skills.
• Self-motivated and strong critical thinking / problem-solving skills. 
• Able to learn new processes, techniques, and disciplines.
• Communication and contact: Communicates effectively both verbally and in writing with superiors, colleagues and individuals inside and outside OHSU.
• Active listening skills; ability to deal with customers in stressful situations; ability to remain calm under pressure
• Relationships with others: Works effectively and relates well with others including superiors, colleagues and individuals inside and outside OHSU
• Exhibits a professional manner in dealing with others and works to maintain constructive working relationships
• Excellent customer service skills 
• Proven ability to undertake multiple priorities concurrently, ability to self-prioritize, and to consistently meet due dates and timelines 
• Ability to work in a collaborative, team-centered work environment and provide helpful support in a timely manner
• Leadership – the ability to get work done through others
• Experience that demonstrates the ability to coach, train and mentor others · High level of integrity
• Bias toward reasonable action
• Change leader
• Tolerance for ambiguity in a high workload, fast-paced environment 
• Attendance and dependability: Can be depended on to report to work at the scheduled time and is seldom absent from work; can be depended upon to complete work in a timely, accurate and thorough manner and is conscientious about assignments; willing to work overtime as necessary depending on volume of work
• Ability to manage small projects from concept to implementation
• Can take a set of requirements to define and scope a project, develop a plan, implement the plan and then bring closure to the project through a review 

• MHA, MPH, or MBA
• Three (3) years of experience in a clinical Cellular Therapy Laboratory
• Quality Management Certifications – ASQ or equivalent 
• MLS(ASCP)CM or equivalent
• Member, International Society for Cell & Gene Therapies (ISCT) 
• Experience in quality management activities associated with cellular therapy processing
• Experience with regulatory accreditation and preparedness 
• Working knowledge of database applications
• OPEx Leader Training, coursework, or equivalent 

• This position works in a fast-paced environment with many interruptions and multiple conflicting priorities.
• This position works with people at all levels of the organization and interacts with numerous internal and external customers.
• The work environment involves everyday risks or discomforts which requires normal safety precautions typical of such places as offices and meeting rooms (i.e., use of safe work practices, avoidance of trips and falls, and observance of fire regulations and traffic signs).
• Work schedule anticipated to be Monday – Friday with the possibility of occasional weekend hours in order to meet deadlines.
• If trained and approved by the CTL Director, there is potential for hands-on cell processing or handling with a risk of exposure to blood and body fluids, chemical hazards; liquid nitrogen exposure, and the required wearing of gloves and other Personal Protective Equipment