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.
ESSENTIAL JOB FUNCTIONS:
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.
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.
This compliance includes: data reported, accreditations, certifications, governmental, state, local and specific donation/transplantation requirements.
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.
Manages the review, analysis, submission and tracking of all inspection observations/responses and submits final reports.
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.
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.
Defines and monitors measures of organizational effectiveness as well as analyzes, trends, and reports such data.
Participates in formulating and administering company policies and developing long range goals and objectives.
Continue to develop Lean culture and Lean Leaders
Apply for Oklahoma Quality Award
Apply for Baldrige National Quality Award
Presents the organizational quality plan to the LifeShare Governing Board of Directors along with periodic updates on progress toward organizational quality goals.
Along with the CEO, serves as the organization’s Lean champion and leads organizational Lean efforts and Lean program development.
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.
Safeguards the organization through awareness of legal and legislative trends and changes. Decreases organizational risk through appropriate actions.
Conducts donor chart quality assurance reviews. Trains staff in completion of forms and charts. Reports compliance related issues to management.
Provides on-going education to all LifeShare staff on Lean quality, quality improvement processes, and other quality-related topics both routinely and as indicated.
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.
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.
Administers quality systems budget preparation, implementation, and monitoring to affect a well-integrated, efficient operation.
Participates as an active member of the LifeShare Executive Leadership Team.
NON-ESSENTIAL JOB FUNCTIONS:
Note: These “non-essential job functions” represent job functions which the incumbent is responsible for performing. However, if necessary, these job functions could be performed by other personnel.
In collaboration with Human Resources and Operations leadership, is responsible for development and oversight of the clinical operations’ training program to ensure staff is properly trained and competent to perform assigned duties.
In collaboration with Organ Recovery and Donation Services Directors, is responsible for selection, implementation, and validation of clinical processes and equipment (including computerized equipment tracking and preventative maintenance as applicable to regulated activities).
Promotes increased organizational quality systems publications, presentations, and visibility with industry organizations.
Performs other related duties as assigned by the CEO.
PHYSICAL ENVIRONMENT/WORKING CONDITIONS:
This is a full-time position based in Oklahoma City. Normal hours may include planning time, consultation with staff in Oklahoma City and the regional locations, travel to hospitals, professional groups, speaking engagements and education activities.
Working evenings and weekends may be required occasionally to perform the tasks outlined in the job description.
Must be able to effectively communicate in a variety of environments, both indoor and outdoor, and under a variety of environmental conditions.
Travel by personal auto, charter or commercial aircraft may be required with reimbursement for personal auto use provided by the company policy according to IRS policy. (Essential job function)
Position requires finger dexterity which would normally be used to operate a telephone, calculator, and computer equipment.
Must have command of the English language and be able to speak clearly to convey information to business contacts and other LifeShare employees over the phone and in person.
Requires ability to work under stress with numerous interruptions, distractions, and changing priorities.
Must have the mental capacity to retain business and technical information.
Must have vision correctable to 20/20 in order read correspondence, reports, and computer screens.
Must be able to sit for at least eight hours a day.
The Vice President of Quality Systems is expected to maintain confidentiality of all donor/recipient information.
EDUCATION AND WORK EXPERIENCE QUALIFICATIONS:
Bachelor’s degree in healthcare or related field and/or equivalent education and work experience required. Master’s degree preferred.
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.
Minimum of five years overall quality management experience in healthcare. Additionally a minimum five years of Organ Procurement Organization Quality Management experience strongly preferred.
Previous work experience in regulatory compliance and advanced quality systems’ required (FDA, CMS, ASQ, Lean, Six Sigma, etc.).
Ability to lead the organizational Lean journey through Leadership training, Lean Mentoring, and staff driven improvement projects.
Ability to apply consistent standards with flexibility for various department functions required.
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.
Strong interpersonal skills and the ability to work both independently and as part of a team required.
Highly motivated, strong attention to detail, and leadership skills required.
Internal Number: 1
About LifeShare Transplant Donor Services of Oklahoma, Inc.
LifeShare Transplant Donor Services of Oklahoma, Inc. (LifeShare) facilitates the recovery of organs and tissues in the state of Oklahoma, serving 3.8 million people.
LifeShare employs 89 staff members committed to the mission of saving and enhancing lives through organ and tissue donation.
LifeShare has a generous benefit package which includes: health/dental; short-term/long-term diability; life insurance; 401(k); cafeteria 125 plan; annual/sick leave accrual; and tuition reimbursement.