Job Summary:
Provides strategic leadership and direction for a Northern California Region clinical laboratory-wide integrated regulatory compliance and risk management system that will differentiate TPMG laboratories from their competitors positively in the area of quality, service, regulatory compliance, and cost effectiveness. Serves as a Regulatory Compliance expert to the Northern California Region clinical laboratory system leadership. Serves as the Northern California Region clinical laboratory system liaison to the regulatory and accreditation agencies in matters that are important to the regions clinical laboratory compliance efforts and operations strategically. Supports Northern California Region Clinical Laboratory Directors in quality and regulatory compliance improvement.

Essential Responsibilities:

• Under the broad guidelines and mission provided by the Northern California Region clinical laboratory system stakeholders (such as Regional Laboratory Director, Regional Laboratory Administrator, Clinical Laboratory Directors, Clinical Laboratory Administrative Directors, and TPMG Executive Office).


• Provides strategic leadership and direction for a Northern California Region clinical laboratory-wide integrated regulatory compliance and risk management system that will differentiate TPMG laboratories positively from their competitors in the area of quality, service, regulatory compliance, risk management and cost effectiveness. Ensures the integration of clinical laboratory continuous quality improvement, and regulatory compliance standards and best practices.


• Provides leadership in building a region-wide clinical laboratory regulatory compliance and risk management team, which will serve as one of the main conduits for the Northern California Region clinical laboratory quality and regulatory compliance standardization processes.


• Serves as a Regulatory Compliance and Risk Management expert to the Northern California Region clinical laboratory system leadership on quality and regulatory compliance. Aggressively mitigates regulatory risk areas. Leads in the evaluation of compliance with regulatory and accreditation agencies requirements through an infrastructure for compliance readiness assessment. Ensures regulatory inspection readiness.


• Serves as the Northern California Region clinical laboratory system liaison to the regulatory and accreditation agencies in matters that are importance to the regions clinical laboratory compliance efforts and operations strategically. Establishes contacts and working relationships with the regulatory and accreditation agencies. Assesses, interprets, and coordinates stakeholders opinions as to the impacts of various proposed laboratory laws and regulations to the Kaiser Permanente organization and services with our government liaisons.


• Supports Northern California Region Clinical Laboratory Directors in quality and regulatory compliance improvement. Supports laboratories in meeting regulatory requirements such as preparing for laboratory licensing application, routine, or complaint inspection and remedial actions as needed.


• Provides leadership in promoting a culture of continuous quality and service improvement and consistent regulatory compliance in the Northern California Region clinical laboratory system. Identifies improvement opportunities and coordinates processes and procedures to reduce laboratory risks.


• Collaborates with TPMG Compliance Office, Accreditation, Regulation, & Licensing, Northern California Region Risk Management and Patient Safety Committee, Northern California Region Quality Oversight Committee, TPMG Medical/Legal, Program Legal, TPMG Government Affairs, and other departments as appropriate to ensure continuous regulatory compliance and quality improvement.


• Develops clinical laboratory quality practice and regulatory compliance training and mentoring programs for clinical laboratorians who are assigned in quality and regulatory compliance areas.


• Supports Labor/Management Partnership initiatives.






• Supports the Principles of Responsibilities by maintaining the privacy and confidentiality of information, protecting the assets of the organization, acting with ethics and integrity, reporting non-compliance, and adhering to applicable federal, state and local laws and regulations, accreditation and licensing requirements as applicable, and Kaiser Permanentes policies and procedures.


• Kaiser Permanente conducts compensation reviews of positions on a routine basis. At any time, Kaiser Permanente reserves the right to reevaluate and change job descriptions, or to change such positions from salaried to hourly pay status. Such changes are generally implemented only after notice is given to affected employees.

Basic Qualifications: Experience

• Minimum ten (10) years of experience in a high-volume clinical laboratory required with at least five (5) years directly related quality and regulatory compliance experience.

Education

• Bachelors degree in Clinical Laboratory Science or related field.

License, Certification, Registration

• Limited Specialty License (California) OR Clinical Laboratory Scientist License (California)

Additional Requirements:

• 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 a Labor/Management Partnership environment.

Preferred Qualifications:

• Masters degree in health care administration, business administration, public administration or related field with additional studies in quality management.

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