Mar 17, 2019
The Director, Laboratory Quality & Compliance is responsible for developing, maintaining and continually improving a standardized Laboratory Quality Management Program (QMP) across the enterprise. Directs and coordinates the quality and compliance related activities of the QMP, ensuring completion of tasks to effectively support the provision of safe, reliable service in all acute, Foundation and free-standing Laboratory operations across the enterprise. Oversees the Laboratory Compliance and Internal Audit processes, planning and coordinating enterprise-wide internal audits to ensure ongoing excellence in quality and service. Develops, maintains and oversees the Point-of-Care Testing Program, ensuring access to appropriate and safe laboratory testing in all ambulatory spaces across the enterprise (e.g. Walk In Clinics, Urgent Care and Sutter Care at Home). Coordinates the monitoring, reporting and assessment of performance-related information for all Sutter Health laboratories. Also coordinates the quality review activities of the Bay and Valley Medical and Operations Management teams to ensure continual improvement of quality and service. Facilitates the design and validation of efficient workflow processes, conducts quality-related meetings, and develops documents (process maps/tables, procedures and forms) to guide the activities of the QMP. Ensures regulatory compliance and accreditation readiness of all Sutter Health laboratories by maintaining up-to-date knowledge of requirements and coordinating activities to fulfill requirements. Manages and coordinates activities related to Laboratory Stewardship, ensuring the appropriate, safe utilization of laboratory services and blood products. Promotes a culture of quality by educating others in quality management system fundamentals, programs and tools.
In partnership with the Laboratory Executive Directors and Medical Directors, supports operational and administrative compliance of Sutter Health laboratories with federal requirements under CLIA-88, College of American Pathologists (CAP), the Joint Commission, the State of California and any other related regulatory or accrediting body affecting clinical activities of the laboratory. Assures that lab services are quality focused, progressive, market competitive, customer service oriented and effectively integrated with other components (physicians, hospitals, health plans, etc.) of the Sutter Health enterprise and Sutter Health Laboratory business line.
As a member of the SH Executive Team for Laboratory (ET4L), works within the direction of the Executive Director of Laboratory Finance & Support Services and in tandem with the Director of Laboratory Information Systems, Bay Acute Laboratory Executive Director, Bay Foundation Laboratory Executive Director, Valley Acute Laboratory Executive Director, Valley Foundation Executive Director and the Shared Laboratory Executive Director. Is a key contributor to enterprise-wide laboratory strategic and business plans that align with affiliate/operating unit plans, while also addressing unique needs/opportunities in the lab space. In collaboration with the ET4L, and in coordination with Sutter's overall strategic plan and clinical quality goals, develops and implements operational changes related to business growth throughout the enterprise.
Bachelor's Degree Required
Clinical Lab Scientist License - CLS-L
Certified Professional in Healthcare Quality (CPHQ) Required
• Must have demonstrated ability in laboratory management (e.g. having worked as a Supervisor or above) minimum 2 years experience.
• Experience in quality control, quality assurance, technical writing, process management, and project management is required.
• Experience in program development (e.g. proficiency testing, internal audit, compliance, etc.) is required.
• Experience in Lean, Six Sigma, Plan-Do-Study-Act and/or other continual improvement techniques is required.
• Experience planning, leading and facilitating meetings is required.
• Experience as a member of a College of American Pathology accreditation team is preferred.
• Experience with a regulatory agency is preferred.
• Experience working in a matrixed reporting relationship is preferred.
**Skills and Knowledge**
• Knowledge of all aspects of the laboratory’s pre-, post- and analytic processes and procedures is required (Clinical Lab, Pathology, Point-of-Care Testing and Transfusion Service).
• Knowledge of the concepts and application of a laboratory quality management system is required.
• Knowledge of continual improvement techniques is required
• Knowledge of regulatory and accreditation requirements is required.
• Working knowledge of basic quality tools such as cause mapping, flow charting, control charts, histograms, check sheets and Pareto charts is required. • Knowledge of Lab Stewardship concepts and approaches is preferred.
• Must have the ability to effectively lead a dispersed team from a centralized location
• Previous experience with organizational change management is highly preferred
• Must have excellent interpersonal (written, oral, presentation) skills and have the flexibility to adapt to a constantly changing environment
• Must have well developed problem identification, analytical, and problem resolution skills, as well as persuasion and negotiation skills
• Must have demonstrated organizational skills with a keen attention to detail and the ability to effectively manage multiple priorities and projects
• Must be able to develop and maintain strong working relationships with a broad and diverse stakeholder base
• Must have excellent leadership skills and the tenacity to deal with complex structures and tasks over a period of time
• Must be able to influence others without defined lines of authority
• Must have demonstrated ability in project management, organizing, prioritizing and coordinating diverse activities in a changing environment
• Must demonstrate proficiency in Microsoft Office programs
• Must demonstrate ability to compile data, analyze it and translate it into meaningful and actionable information through the use of graph/charts
**Organization:** Sutter Shared Lab
**Employee Status:** Regular
**Position Status:** Exempt
**Job Shift:** Day
**Shift Hours:** 8 Hour Shift
**Days of the Week Scheduled:** Monday-Friday
**Weekend Requirements:** None
**Schedule:** Full Time
**Hrs Per 2wk Pay Period:** 80
All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, marital status, sexual orientation, registered domestic partner status, sex, gender, gender identity or expression, ancestry, national origin (including possession of a driver's license issued to individuals who did not present proof of authorized presence in the U.S.), age, medical condition, physical or mental disability, military or protected veteran status, political affiliation, pregnancy or perceived pregnancy, childbirth, breastfeeding or related medical condition, genetic information or any other characteristic made unlawful by local, state, or federal law, ordinance or regulation. External hires must pass a background check/drug screening. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state, and local laws, including but not limited to the San Francisco Fair Chance Ordinance.