At the City of Hope (COH), quality management ensures that our organization, patient care, products or services are consistent. In Pathology it has four main components: quality planning, quality assurance, quality control and quality improvement.
Our quality management approach is focused on patient care, products provided and services, along with the means by which we achieve them. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality.
The Quality and Compliance Director plans, directs, coordinates, and leads all areas/divisions of the Department of Pathology in activities related to quality management, compliance, regulatory affairs and safety. Oversees activities involving the development, implementation, and monitoring of the Pathology Quality Management Program and quality initiatives across the department.
Planning, budgeting, staff development and oversight for the Pathology Quality Management Program. Oversight and leadership of all quality management, compliance, regulatory affairs and safety activities carried out in all areas/divisions of Pathology. Leadership and resources for quality, compliance, regulatory affairs and safety activities in all areas/divisions, to include: clinical and anatomic pathology, clinical molecular diagnostic lab, cytogenetics, and transfusion medicine. Developing strategies to improve the quality standards within the department and ensures compliance is maintained. Liaison with the divisions and other COH departments in matters involving quality, compliance and regulatory affairs.
Compliance and Regulatory Affairs
Reviews, interprets, and assesses application to our operations of all new, existing and revised regulations, standards, guidelines, etc. from regulatory and accrediting agencies.
Reviews and approves all relevant quality policies and procedures in pathology, in collaboration with division’s operational director and medical director.
Monitors errors/accidents/event investigations by tracking, reporting, and follow-up on significant events occurring around the department reviews and approves the systems being used for workflow changes affecting other divisions and/or departments, major process improvement initiatives and system validation activities.
Serves as the primary contact and liaison with all external regulatory and accrediting agencies.
Prepares for, coordinate, host, and follow-up on all inspections and provide reports and requested information for all agencies.
Develops, maintains, and administers the pathology quality management program.
Creates and maintains the infrastructure for the development of a departmental quality management committee.
Serves as chair of the quality management committee with membership from all of the divisions.
Builds collaborative relationships with institutional quality team and ad-hoc committees.
Develop strategies to monitor, maintain and improve quality standards within the department
Leads quality improvement initiatives for the benefit our patients and department. Performs quality audits, walk around observations and other ongoing assessments of operations, and works on performance improvement activities.
Safety and Business Continuity Management
Serves as the primary point of contact for departmental safety issues and collaborates with institutional resources to participate in disaster preparedness drills and exercises.
Collaborates with the institutional business continuity management team to develop, train and exercise departmental and divisional business continuity plans.
Financial and Personnel Management
Budget planning, financial variances tracking, contracting, and ongoing expense monitoring and reporting.
Oversees and develops a team of qualified and competent staff to carry out quality, compliance and safety activities.
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Performs other related duties as assigned or requested.
Bachelor of Science degree
5+ years of related professional experience to include quality management, and laboratory compliance; Some regulatory affairs experience with: CAP, CLIA, Joint Commission, AABB, FDA, FACT, CMS, COLA,CDPH (California Department of Public Health)
California license as a Clinical Laboratory Scientist – CLS (ASCP) or MT (ASCP)
Advanced degree; i.e. MBA, MHA, MPH, etc.
Related quality management and audit experience in the following areas: Clinical and Anatomic Pathology; Blood Banking and blood/cell therapy manufacturing (or equivalent regulated medical manufacturing environment - cGMP); Molecular and Tissue typing Laboratories
Program development, policy development and strategic planning
Epic Beaker, SafeTrace
Office setting with frequent walking to the various areas in transfusion medicine and other departments.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.
Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanc...ed care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation’s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.