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Regional Director Laboratory Quality & Compliance

Regional Director Laboratory Quality & Compliance

Kaiser PermanenteNorth Hollywood, CA, US
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Regional Director Laboratory Quality & Compliance

Provides strategic leadership and direction for the Southern California Region clinical laboratory system. Serves as a Quality and Regulatory Compliance expert to the Southern California Region clinical laboratory system leadership on quality and regulatory compliance. Serves as the Southern 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. Supports Southern California Region Clinical Laboratory Directors and Hospital leaders in supporting continuous quality and regulatory compliance improvement.

Essential Responsibilities :

  • Under the broad guidelines and mission provided by the Southern California Region clinical laboratory system stakeholders :
  • Provides strategic leadership and direction for the Southern California Region clinical laboratory-wide integrated quality and regulatory compliance system.
  • 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 quality and regulatory compliance team.
  • Serves as a Quality and Regulatory Compliance expert to the Southern California Region clinical laboratory system leadership.
  • Aggressively mitigates regulatory risk areas.
  • Leads in the evaluation of compliance with regulatory and accreditation agencies requirements.
  • Ensures regulatory inspection readiness.
  • Serves as the Southern California Region clinical laboratory system liaison to the regulatory and accreditation agencies.
  • 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.
  • Supports Southern California Region Clinical Laboratory Directors in quality and regulatory compliance improvement.
  • Supports laboratories in meeting regulatory requirements.
  • Provides leadership in promoting a culture of continuous quality and service improvement.
  • Identifies improvement opportunities and coordinates processes and procedures to reduce laboratory risks.
  • Collaborates with other departments as appropriate to ensure continuous regulatory compliance and quality improvement.
  • Develops clinical laboratory quality practice and regulatory compliance training and mentoring programs.
  • Supports Labor / Management Partnership initiatives.
  • Supports the Principles of Responsibilities.

Basic Qualifications :

  • Minimum ten (10) years of experience in a high-volume clinical laboratory required with minimum five (5) years directly related quality and regulatory compliance experience.
  • Masters degree in clinical laboratory science; OR
  • Masters degree in health care administration, business administration, public administration or related field with additional studies in quality management related courses, OR
  • Six (6) years of experience in a directly related field.
  • High School Diploma or General Education Development (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 :

  • 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 SCPMG strategic goals.
  • Excellent skills in complex analytic problem solving, strategic planning, program development, project management, change management and group process.
  • Demonstrated knowledge 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.
  • Able to manage several projects simultaneously, complete projects efficiently and on deadline, sometimes with necessarily little lead-time. Influential and effective in both written and verbal communication skills (negotiation, listening and collaboration).
  • Experienced at presenting Proficiency with Microsoft Office (i.e., Excel, Word, Power Point).
  • Must be able to work in a Labor / Management Partnership environment.
  • Other tasks as assigned
  • Preferred Qualifications :

  • N / A.
  • Notes :

  • Require to travel between all Regional Lab Sites.
  • Required to be on-call for director on duty rotation.
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