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Vice President of Quality Systems

Vice President of Quality Systems

Website LifeShare Transplant Donor Services of Oklahoma

Job Title: Vice President of Quality Systems

Reports To: President and Chief Executive Officer

Work Schedule: Full-time

Exemption Status: Exempt

Blood Borne Pathogen Category: Category 2

 

GENERAL STATEMENT (Summary of Duties and Responsibilities):

The Vice President of Quality Systems (VPQS) is responsible for directing and coordinating quality systems processes related to all aspects of organizational operations.  This position collaborates with the organization’s senior leadership team to assure the organizational quality program functions comprehensively.  This position also supports the President and Chief Executive Officer (CEO) in ensuring compliance with regulatory, accreditation, and legislative standards and ensures that goals are set and measured to continuously improve practice.

EDUCATION AND WORK EXPERIENCE QUALIFICATIONS:

  1. Bachelor’s degree in healthcare or related field and/or equivalent education and work experience required.  Master’s degree preferred.
  2. Certifications preferred include: Certified Procurement Transplant Coordinator (CPTC), Certified Tissue Bank Specialist (CTBS), ASQ Certified Manager/Organizational Excellence Certification or Six sigma Greenbelt or Blackbelt.
  3. Minimum of five years overall quality management experience in healthcare.  Additionally a minimum five years of Organ Procurement Organization Quality Management experience  strongly preferred.
  4. Previous work experience in regulatory compliance and advanced quality systems’  required (FDA, CMS, ASQ, Lean, Six Sigma, etc.).
  5. Ability to lead the organizational Lean journey through Leadership training, Lean Mentoring, and staff driven improvement projects.
  6. Ability to apply consistent standards with flexibility for various department functions required.
  7. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with abstract and/or concrete variables.  Ability to define problems, collect data, establish facts, and draw valid conclusions required.
  8. Strong interpersonal skills and the ability to work both independently and as part of a team required.
  9. Highly motivated, strong attention to detail, and leadership skills required.

ESSENTIAL JOB FUNCTIONS:

  1. Must exhibit and model LifeShare’s organizational clarity (core purpose, core values, business definition, and strategic anchors) in all job functions and in all interactions both internal and external to LifeShare.
  2. Sets regulatory and compliance policies for the organization.  Ensures that the organization attains and maintains compliance with all current federal, state, local laws and regulations of the United Network for Organ Sharing (UNOS), Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), the Association of Organ Procurement Organizations (AOPO) Standards, and the American Association of Tissue Banks (AATB), and other applicable regulations.
  3. This compliance includes:  data reported, accreditations, certifications, governmental, state, local and specific donation/transplantation requirements.
  4. Is the point person for LifeShare on all site visits/audits/inspections by any regulatory body.  Interfaces directly with regulatory personnel, keeps detailed records of items requested/provided to regulatory personnel, and advises LifeShare’s CEO and Leadership/Staff that may be interviewed by the regulatory personnel.
  5. Manages the review, analysis, submission and tracking of all inspection observations/responses and submits final reports.
  6. Utilizing Lean principles, directs the continuing review of operational quality processes and the formulation of new or revised procedures to affect improvements, reduce cost, and enhance efficiency on an organization-wide basis. Directs service satisfaction monitoring and outcomes management.
  7. Responsible for the development and oversight of the quality system program to include the following areas: document control, error/accident management, complaint management, adverse outcome investigation/management, supplier quality approval, training, equipment management, validations, process review, change control, materials management, and other regulatory requirements.
  8. Defines and monitors measures of organizational effectiveness as well as analyzes, trends, and reports such data.
  9. Participates in formulating and administering company policies and developing long range goals and objectives.
  10. Continue to develop Lean culture and Lean Leaders.
  11. Apply for Oklahoma Quality Award
  12. Apply for Baldrige National Quality Award
  13. Presents the organizational quality plan to the LifeShare Governing Board of Directors along with periodic updates on progress toward organizational quality goals.
  14. Along with the CEO, serves as the organization’s Lean champion and leads organizational Lean efforts and Lean program development.
  15. Responsible for providing leadership and direction to assigned staff including staff   performance review, professional development and monitoring activities of assigned  employees.  Acts as a coach, mentor and consultant to assigned staff members as related to compliance and quality assurance.
  16. Safeguards the organization through awareness of legal and legislative trends and changes. Decreases organizational risk through appropriate actions.
  17. Conducts donor chart quality assurance reviews.  Trains staff in completion of forms and charts.  Reports compliance related issues to management.
  18. Provides on-going education to all LifeShare staff on Lean quality, quality improvement processes, and other quality-related topics both routinely and as indicated.
  19. Administrator for Q-Pulse system.  This includes set-up, maintenance, and configuration of the modules within the system.  The modules include Document Control, CAPA, Audit, People, Training, Suppliers, Assets, Risk Analysis, and Administration.
  20. With input from the Clinical Research and Quality System Coordinator, develop and implement the Gael Risk Tool.  Ensure the organization is assessing hazard and threat areas, determining risk scores and assessing the effectiveness of the controls that are to manage the overall risks identified.
  21. Administers quality systems budget preparation, implementation, and monitoring to affect a well-integrated, efficient operation.
  22. Participates as an active member of the LifeShare Executive Leadership Team.

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