Overview

Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

Position Summary

Develops ongoing quality assessment and performance improvement plan for the organ procurement organization and tissue bank under the guidance of the Vice President of Organ and Tissue Donation. Serves as liaison to Versiti Quality and Regulatory Affairs department. Ensures operational compliance to OPTN policy, CMS and FDA regulations, AATB and tissue processor policies and requirements. Oversees data analytics function, data collection and reporting, donor chart review, and validations. Leads event management, policy review, updates, and training. Manages internal and external audits with Quality and Regulatory Affairs.

Total Rewards Package

BenefitsVersiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.

Responsibilities

• Understands how applicable laws, regulations, standards, policies and procedures impact specific job responsibilities and functions and performs assigned job functions in accordance with them to include those set forth by AATB (American Association of Tissue Banks), FDA (Food and Drug Administration), AORN (The Association of Perioperative Registered Nurses), OSHA (Occupational Safety and Health Administration), and JCAHO (Joint Commission on Accreditation of Healthcare Organizations), OPTN (Organ Procurement and Transplant Network), and CMS (Center for Medicare).
• Demonstrates leadership ability including ability to influence, inspire, and motivate others in a result-driven environment.
• Manages team of direct reports including data analyst and record reviewers
• Manages, leads, and actively participates in the use of Lean and/or continuous quality improvement methodologies and tools including value stream mapping, and Kaizen events
• Reviews and monitors data on deviations and nonconformance and manages benchmarking process for national trend analysis and creates reports
• Manages sampling review of records. Ensures that records are complete, accurate, and organized. Ensures that records have appropriate sign off and that any issues have been identified, resolved, communicated, and documented. Ensure that necessary clinical data has been collected and noted in the records.
• Manages development and execution of validation plans for systems and equipment.
• Collaborates with Quality and Regulatory Affairs for internal and external audits.
• Manages CMS QAPI Plan and Emergency Preparedness annual reviews.
• Manages document management systems, including coordinating creation of documents (such as new and revised policies), ensuring ongoing review/updates of documents, coordinate form changes and approvals, obtaining approval from tissue processors when applicable, distributing new and revised polices to staff, and archiving retired documents.
• Ensures regulatory changes are incorporated into documents and communicated as appropriate.
• Investigates accidents, deviations, and nonconformances. Ensures that root cause analysis, corrective action, and preventative action are carried out.
• Manages and tracks required training and competencies for service line
• Prepares operations team for site visits by regulatory and accrediting agencies and tissue processors including supplier audits and recovery facility inspections
• Coordinates and/or participates in various donation related community activities/events as assigned
• Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification
• Understands and performs in accordance with all applicable regulatory and compliance requirements
• Complies with all standard operating policies and procedures

Qualifications

Education

• Bachelor's Degree in Clinical Laboratory Science, Scientific discipline or Healthcare related required
• Equivalent combination of education and related experience (3-5 years) may be substituted for the degree with HR approval required

Experience

• 4-6 years of experience in a technical or quality/regulatory support capacity required
• 1-3 years of leadership experience required
• 1-3 years Data analysis and report creation experience preferred
• 1-3 years QC or record review experience strongly preferred
• OPO/Tissue experience desired

Knowledge, Skills and Abilities

• Strong organizational skills with excellent interpersonal, verbal, and written communication skills including the ability to communicate technical information to stakeholders required
• Ability to exercise initiative and independent judgment in addressing procedural, technical and equipment problems required
• Ability to handle sensitive documents and information with the utmost discretion and diplomacy as well as exercising absolute discretion when dealing with confidential matter required
• Demonstrates ability to proactively develop innovative approach to current and emerging business challenges in a fast-changing environment. required
• Ability to understand, interpret, and communicate data generated from production and service activities, including statistical application and analysis skills as well as make recommendations for improvements and corrective actions required
• Knowledge of medical terminology preferred
• Proficient in Microsoft Office applications, as well as the ability to learn and effectively use other preferred
• Demonstrated knowledge of navigating computer systems utilized for the capture of patient/donor information, including medical records preferred

Tools and Technology

• Personal Computer (desktop, laptop, tablet) required
• General office equipment (computer, printer, fax, copy machine) required
• Microsoft Suite (Word, Excel, PowerPoint) required