Provides strategic leadership & direction for a NCal Region clinical lab-wide integrated quality & regulatory compliance system that will differentiate TPMG labs from their competitors positively in the area of quality, service, regulatory compliance, & cost effectiveness. Serves as a Quality & Regulatory Compliance expert to the NCal Region clinical lab system leadership on quality & regulatory compliance. Serves as the NCal Region clinical lab system liaison to the regulatory & accreditation agencies in matters that are important to the region's clinical lab compliance efforts & ops strategically. Supports NCal Region Clinical Lab Directors in quality & regulatory compliance improvement.
Essential Functions:
- Under the broad guidelines & mission provided by the NCal Region clinical Lab system stakeholders:
- Provides strategic leadership & direction for a NCal Region clinical Lab-wide integrated quality & regulatory compliance system that will differentiate TPMG labs positively from their competitors in the area of quality, service, regulatory compliance, & cost effectiveness
- Ensures the integration of clinical Lab continuous quality improvement, & regulatory compliance standards & best practices
- Provides leadership in building a region-wide clinical Lab quality & regulatory compliance team, which will serve as one of the main conduits for the NCal Region clinical Lab quality & regulatory compliance standardization processes
- Serves as a Quality & Regulatory Compliance expert to the NCal Region clinical Lab system leadership on quality & regulatory compliance
- Aggressively mitigates regulatory risk areas
- Leads in the evaluation of compliance w/ regulatory & accreditation agencies' requirements through an infrastructure for compliance readiness assessment
- Ensures regulatory inspection readiness
- Serves as the NCal Region clinical Lab system liaison to the regulatory & accreditation agencies in matters that are importance to the region's clinical Lab compliance efforts & ops strategically
- Establishes contacts & working relationships w/ the regulatory & accreditation agencies
- Assesses, interprets, & coordinates stakeholders' opinions as to the impacts of various proposed Lab laws & regulations to the KP organization & services w/ our government liaisons
- Supports NCal Region Clinical Lab Directors in quality & regulatory compliance improvement
- Supports labs in meeting regulatory requirements such as preparing for Lab licensing application, routine, or complaint inspection & remedial actions as needed
- Provides leadership in promoting a culture of continuous quality & service improvement & consistent regulatory compliance in the NCal Region clinical Lab system
- Identifies improvement opportunities & coordinates processes & procedures to reduce Lab risks
- Collaborates w/ TPMG Compliance Office, Accreditation, Regulation, & Licensing, NCal Region Risk Management & Patient Safety Committee, NCal Region Quality Oversight Committee, TPMG Medical/Legal, Program Legal, TPMG Government Affairs, & other departments as appropriate to ensure continuous regulatory compliance & quality improvement
- Develops clinical Lab quality practice & regulatory compliance training & mentoring programs for clinical laboratorians who are assigned in quality & regulatory compliance areas
- Supports Labor/Management Partnership initiatives
Qualifications:
Basic Qualifications:
- Extensive experience in a high-volume clinical laboratory required, usually ten (10) years, with at least five (5) years directly related quality and regulatory compliance experience
- Master's degree in Clinical Laboratory Science or related field OR master's degree in health care administration, business administration, public administration or related field with additional studies in quality management related courses required
- Valid current California Clinical Laboratory Scientist or limited specialist license required
- Demonstrated ability and track record to apply cutting edge quality system theories, techniques, principles, practices, processes, or methods to initiate change in the clinical laboratory quality, service, and compliance performance to meet TPMG strategic goals
- Excellent skills in complex analytic problem solving, strategic planning, program development, project management, change management and group process
- Demonstrable knowledge of and effective use of statistical tools and techniques for problem solving and process improvement
- Demonstrated effectiveness in staff development, team building, conflict resolution and group interaction
- Proficiency with Microsoft Office (i.e., Excel, Word, Power Point)
- Must be able to work in Labor/Management Partnership environment
External hires must pass a background check/drug screen.
We are proud to be an equal opportunity/affirmative action employer.