Director of Quality & Regulatory Affairs

POSITION SUMMARY

The Director of Quality & Regulatory Affairs (DQRA) is responsible for assisting the Vice President of Quality & Regulatory Affairs (VP QRA) with the execution of the NDN Quality Management System including continual quality improvement throughout the organization.  Directs the development, implementation and monitoring of quality systems and regulatory compliance related to internal standards, industry standards, state, local and federal regulations, departmental and organizational goals and processes.  Assist with the overall direction for consistency and training for those managed.  The Director serves as an advocate and resource for quality programs and provides interpretations of regulations and standards for consideration in the formulation of business strategies related to organ, tissue, and ocular recovery as well as administrative operations.

 ESSENTIAL FUNCTIONS

• Directs, manages, and provides oversight for all activities related to the Quality Management System (QMS) and performance improvement.
• Develops and maintains a quality plan to ensure the best service possible. Oversees the implementation of the NDN’s QMS. At a minimum, activities will include and are not limited to Performance Improvement, Customer Complaint, Planned Deviation, Corrective Action/Preventive Action, Auditing, Document Control, Chart QA, Validation, and Death Record Review Systems.
• Promotes quality assurance with the expectation of accurate donor medical records and data elements, and validation of all performance data. 
• Implements, monitors and reviews systems and programs instituted to provide consistent adherence to policies related to organ, tissue and ocular recovery, laboratory and administrative operations. 
• Responsible for the administration of the electronic quality management system platform, Q-Pulse.

• Ensures organizational compliance with regulatory standards including AOPO, UNOS, CDC, CMS, AATB, EBAA, CLIA, FDA including all aspects of cGTPs, ASHI and the State of Nevada as appropriate. Ensures all regulatory and governmental licenses are kept current.
1. Monitors and analyzes information release and activity pertaining to federal, state, and industry standards as it relates to regulatory compliance and organizational operations.
2. Ensures policies and procedures reflect regulations and standards and collaboratively leads the revision of policies and procedures, as needed to reflect any applicable regulatory changes.
• Develops, oversees and maintains a quality plan that aligns to the NDN Quality Manual and Quality Excellence Program (QEP) in order to advance the NDN mission and core purpose.
• Deploys and maintains an effective QMS to foster a culture of improvement through data analysis in collaboration with all NDN departments.
1. Promotes use of the organization’s quality improvement process by evaluating, improving, improving workflow, and maximizing process efficiencies.
• Assists in the development and analysis of all statistical performance measurements of organ, tissue, ocular, HLA, and administrative operations, and quality and regulatory compliance throughout the organization.  Conducts ongoing monitoring and data analysis, trending and reporting of the quality management systems including but not limited to occurrences, planned deviations, customer complaints, sentinel events, and adverse reactions and outcomes. Identify opportunities for improvements.
1. Reports meaningful data related to activity levels, quality measures, and regulatory compliance to NDN leadership, staff, advisory board members, and various stakeholders.

 Collaborates with other organ, tissue and ocular recovery agencies to keep current on industry best practices and works to deploy the same in the organization.

• Represents NDN at various meetings and conferences including the Association of Organ Procurement Organization (AOPO), American Association of Tissue Banking (AATB), and Eye Bank Association of America (EBAA) councils and committees. Promotes NDN and the brand through actively participating and presenting at these conferences.
• Manages the selection, training, development, and performance of assigned staff to retain a motivated, professional workforce for the department.

• Recruits and selects applicants for job vacancies considering the requirements of the job and the skills/abilities of the applicants.
• Establishes and communicates job responsibilities as well as employee performance expectations to assure mutual understanding of desired results.
• Identifies training and/or development opportunities that will assist the employee in achieving enhanced job performance and/or career objectives.
• Constructively coaches and counsels for success to seek optimal employee performance.
• Builds support and alliances between and among departments to promote the organizational core values.
• Conducts performance reviews in alignment with job expectations, as well as reviews salary accordingly.

• Develop and implement a cross-functional internal audit program to ensure the application of organization policies and procedures as well as the adherence to applicable regulatory and accrediting regulation and standard requirements in the actions of the organization.
1. Oversees all phases of audits initiated by regulatory agencies and external customer-initiated audits.
2. Liaison for formal resolutions to compliance concerns brought forth by auditors including regulatory bodies.
3. Oversees all phases of the organization’s qualification audits of its vendors. 
• Maintains the document control system for the organization
1. Assists in the review, creation, update, and maintenance of all organizational standard operating policies and procedures.  Ensures that all policies and procedures are in compliance with applicable local, state, federal, and industry standards and regulations. 
2. Utilizes the electronic quality management system platform to maintain the document control system for the organization’s controlled documents.   
3. Ensures all staff receive and adequately complete read acknowledgement training on all relevant controlled documents.   
• Manages the occurrence reporting system to ensure adequate and effective corrective and preventive actions are taken. 
• Oversight for positive serology reporting in accordance with local, state, and federal regulations and accrediting standards.
• Oversight for organizational training related to quality tools through internal and external sources.
• Plan and uphold departmental budget through strategic planning in collaboration with Senior Leadership Team to support the goals of the organization.
• As appropriate, develops or assists in development of verification or validation of equipment, processes, and electronic systems.
• Perform other duties as assigned.

 Reasonable Accommodations Statement

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.