Kaiser Permanente
Regional Director Laboratory Quality & Compliance
Kaiser Permanente, Los Angeles, California, United States, 90079
Overview
Regional Director Laboratory Quality & Compliance is a leadership role at Kaiser Permanente for the Southern California Region clinical laboratory system. The role provides strategic leadership and direction for quality and regulatory compliance, serves as the liaison to regulatory and accreditation agencies, and supports leaders in continuous quality and regulatory compliance improvement. Responsibilities
Under the broad guidelines and mission provided by the Southern California Region clinical laboratory system stakeholders (includes Regional Laboratory Physician Leaders, Regional Laboratory Managers, and SCPMG Executive Office): Provide strategic leadership and direction for the Southern California Region clinical laboratory-wide integrated quality and regulatory compliance system to differentiate SCPMG laboratories in quality, service, regulatory compliance, and cost effectiveness. Ensure integration of clinical laboratory continuous quality improvement and regulatory compliance standards and best practices. Lead in building a region-wide clinical laboratory quality and regulatory compliance team to support standardization processes. Serve as a Quality and Regulatory Compliance expert to the Southern California Region clinical laboratory system leadership on quality and regulatory compliance. Aggressively mitigate regulatory risk areas. Lead the evaluation of compliance with regulatory and accreditation requirements through an infrastructure for compliance readiness and inspection readiness. Serve as the liaison to regulatory and accreditation agencies and establish professional contacts with them. Assess, interpret, and coordinate stakeholder opinions on impacts of proposed laboratory laws and regulations with government liaisons. Support Clinical Laboratory Directors in quality and regulatory compliance improvement and assist laboratories in meeting regulatory requirements such as licensing applications, inspections, and remedial actions as needed. Promote a culture of continuous quality and service improvement and ensure consistent regulatory compliance in the Southern California Region clinical laboratory system. Identify improvement opportunities and coordinate processes to reduce laboratory risks. Collaborate with SCPMG and other departments to ensure continuous regulatory compliance and quality improvement. Develop training and mentoring programs for clinical laboratorians assigned to quality and regulatory compliance areas. Support Labor/Management Partnership initiatives. Maintain privacy and confidentiality, protect organizational assets, act with ethics and integrity, report non-compliance, and adhere to applicable laws, regulations, licensing requirements, and policies. Experience
Basic Qualifications
Minimum ten (10) years of experience in a high-volume clinical laboratory, with at least five (5) years of directly related quality and regulatory compliance experience. Education
Masters degree in clinical laboratory science; OR Masters degree in health care administration, business administration, public administration or related field with additional quality management studies; OR Six (6) years of experience in a directly related field. High School Diploma or GED required. License, Certification, Registration
Clinical Cytogeneticist Scientist License (California) OR Clinical Microbiologist Scientist License (California) OR Clinical Laboratory Scientist License (California) OR Clinical Hematologist Scientist License (California) OR Clinical Genetic Molecular Biologist Scientist License (California) OR Clinical Chemist Scientist License (California) OR Clinical Histocompatibility Scientist License (California) OR Clinical Toxicologist Scientist License (California) OR Clinical Immunohematologist License (California). Additional Requirements
Ability to apply cutting-edge quality system theories and practices to initiate change in laboratory quality, service, and compliance to meet SCPMG strategic goals. Strong skills in complex analytic problem solving, strategic planning, program development, project management, change management, and group process. Knowledge and effective use of statistical tools for problem solving and process improvement. Experience in staff development, team building, conflict resolution, and group interaction. Ability to manage multiple projects simultaneously and communicate effectively in writing and verbally. Proficiency with Microsoft Office (Excel, Word, PowerPoint). Must be able to work in a Labor/Management Partnership environment. Other tasks as assigned. Notes
Travel between all Regional Lab Sites is required. On-call for director on duty rotation.
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Regional Director Laboratory Quality & Compliance is a leadership role at Kaiser Permanente for the Southern California Region clinical laboratory system. The role provides strategic leadership and direction for quality and regulatory compliance, serves as the liaison to regulatory and accreditation agencies, and supports leaders in continuous quality and regulatory compliance improvement. Responsibilities
Under the broad guidelines and mission provided by the Southern California Region clinical laboratory system stakeholders (includes Regional Laboratory Physician Leaders, Regional Laboratory Managers, and SCPMG Executive Office): Provide strategic leadership and direction for the Southern California Region clinical laboratory-wide integrated quality and regulatory compliance system to differentiate SCPMG laboratories in quality, service, regulatory compliance, and cost effectiveness. Ensure integration of clinical laboratory continuous quality improvement and regulatory compliance standards and best practices. Lead in building a region-wide clinical laboratory quality and regulatory compliance team to support standardization processes. Serve as a Quality and Regulatory Compliance expert to the Southern California Region clinical laboratory system leadership on quality and regulatory compliance. Aggressively mitigate regulatory risk areas. Lead the evaluation of compliance with regulatory and accreditation requirements through an infrastructure for compliance readiness and inspection readiness. Serve as the liaison to regulatory and accreditation agencies and establish professional contacts with them. Assess, interpret, and coordinate stakeholder opinions on impacts of proposed laboratory laws and regulations with government liaisons. Support Clinical Laboratory Directors in quality and regulatory compliance improvement and assist laboratories in meeting regulatory requirements such as licensing applications, inspections, and remedial actions as needed. Promote a culture of continuous quality and service improvement and ensure consistent regulatory compliance in the Southern California Region clinical laboratory system. Identify improvement opportunities and coordinate processes to reduce laboratory risks. Collaborate with SCPMG and other departments to ensure continuous regulatory compliance and quality improvement. Develop training and mentoring programs for clinical laboratorians assigned to quality and regulatory compliance areas. Support Labor/Management Partnership initiatives. Maintain privacy and confidentiality, protect organizational assets, act with ethics and integrity, report non-compliance, and adhere to applicable laws, regulations, licensing requirements, and policies. Experience
Basic Qualifications
Minimum ten (10) years of experience in a high-volume clinical laboratory, with at least five (5) years of directly related quality and regulatory compliance experience. Education
Masters degree in clinical laboratory science; OR Masters degree in health care administration, business administration, public administration or related field with additional quality management studies; OR Six (6) years of experience in a directly related field. High School Diploma or GED required. License, Certification, Registration
Clinical Cytogeneticist Scientist License (California) OR Clinical Microbiologist Scientist License (California) OR Clinical Laboratory Scientist License (California) OR Clinical Hematologist Scientist License (California) OR Clinical Genetic Molecular Biologist Scientist License (California) OR Clinical Chemist Scientist License (California) OR Clinical Histocompatibility Scientist License (California) OR Clinical Toxicologist Scientist License (California) OR Clinical Immunohematologist License (California). Additional Requirements
Ability to apply cutting-edge quality system theories and practices to initiate change in laboratory quality, service, and compliance to meet SCPMG strategic goals. Strong skills in complex analytic problem solving, strategic planning, program development, project management, change management, and group process. Knowledge and effective use of statistical tools for problem solving and process improvement. Experience in staff development, team building, conflict resolution, and group interaction. Ability to manage multiple projects simultaneously and communicate effectively in writing and verbally. Proficiency with Microsoft Office (Excel, Word, PowerPoint). Must be able to work in a Labor/Management Partnership environment. Other tasks as assigned. Notes
Travel between all Regional Lab Sites is required. On-call for director on duty rotation.
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