Director of Quality and Regulatory Affairs

About the Director of Quality and Regulatory Affairs:

This position is responsible for providing organizational leadership for the overall quality management system and regulatory affairs in alignment with Donor Network of Arizonas Mission, strategy, and organizational goals. The Director shall oversee, create, and drive the vision and implementation of robust quality systems, including quality assurance of donor records, quality control, document control, process validation, supplier qualification, auditing, and nonconformance and occurrence management with CAPA and RCA. This position will collaborate with the Department Directors, Medical Directors, and others as it relates to the organizations quality improvement process and shall ensure that quality systems data is collected and analyzed, and that quality goals are created and monitored for ongoing improvement in DNAs pursuit of excellence.

As the DNA leader for regulatory affairs, the Director shall ensure a robust system for monitoring regulations and industry standards and then collaborating with other DNA leaders for process improvement and change management to ensure that DNA is compliant and/or exceeds standards set forth by CMS, OPTN/UNOS, FDA, AATB, EBAA, OSHA, transplant partners, and other relevant federal, state, or local entities. The Director shall provide a confident Quality and Regulatory Affairs leadership voice for DNA and its stakeholders.

Finally, this position is responsible for implementing DNAs culture and core values in staffing, engaging, and supporting a highly effective Quality and Regulatory Affairs team.

Job Duties:

Leadership
As a member of the director team, assists with and provides direction to the strategic planning activities of the organization including goal development as well as resultant monitoring activities to ensure effective and thorough goal completion.
Develops and implements department and functional level strategy for quality in alignment with Donor Network of Arizonas mission, strategy, and organizational goals.
Creates and monitors quality department budget preparation, implementation and monitoring to establish a well-integrated and efficient operation.
Ensures all leadership and management responsibilities for employees in areas of responsibility are implemented and alignment with Donor Network of Arizona human resources, safety, and other applicable policies, procedures, and leadership competencies.
Represents DNA and actively engages in quality and regulatory related industry association meetings, councils, committees, learning forums, etc. Seeks leadership opportunities within these as appropriate and agreed upon with Senior Vice President.
Creates, deploys, and maintains currency of DNA Quality Plan which serves as a documented framework for the essential Quality Systems and Regulatory Affairs

Quality Systems
Document Control: Oversees the retention of organizational controlled documents, standard operating procedures and donor records.
Ensures all standard operating procedures are written, implemented, approved, revised and retained according to the established policy in accordance with applicable legal, regulatory, and/or other requirements.
Quality Assurance and Quality Control: Ensures thorough and accurate compliance with all pertinent federal, local national and state regulatory agencies, industry associations, partner and customer contracts and requirement, and other organ/tissue recovery quality standard requirements. This includes but is not limited to quality review of donor records for organ, tissue, and/or ocular donors, donor case review, equipment and environmental monitoring.
Directs organizational and departmental quality systems data monitoring, review, and analysis to ensure compliance and identify gaps and opportunities for continuous improvement.
Donor Records Management: Ensures the secure and confidential storage of donor records and an efficient and confidential process for the release of donor information to appropriate entities.
Quality Improvement: Collaborates with the Medical Directors, CEO, SVP, Vice Presidents and Department Directors as it relates to the organizations systems for maintaining and improving quality and performance improvement process. Promotes the use of DNAs quality improvement process to evaluate and improve processes to maximize efficiency and effectiveness, compliance, productivity, and other desired outcomes.
Audit Management: Ensures a robust system for internal and external audits - including supplier audits and 3rd party audits (tissue processors, partner audits, accreditation and regulatory audits).
Nonconformance and Occurrence Management: Directs a system for managing and monitoring occurrences, nonconformance, waivers & deviations, complaints and sentinel events. Conducts ongoing monitoring of these systems , identifying trends and gaps that feed into the improvement processes.
Measurement and Monitoring: Works with Vice Presidents and Department Directors to establish indicators to measure the effectiveness of services and processes implemented to achieve organizational objectives for quality, compliance, performance, and improvement.
Directs and provides education of DNA and departmental staff regarding quality management systems and regulatory affairs topics, processes, methods, etc.
Collaborates and performs technical support services providing guidance, tools, training, resources, and internal consulting on improvement projects.
Participates in quality reviews with external partners and customers
Supplier Qualification: Ensures that supplies, equipment, and facilities utilized in operations and clinical processes meet quality and regulatory standards.
Leverages the organizations analytic environment to guide data driven decision making and inform quality improvement initiatives while overseeing and guiding related activities.

Regulatory Affairs
Collaborates with Executive Leadership Team and Department Directors to ensure that DNA is fully compliant with regulatory requirements: CMS, OPTN/UNOS, FDA, AATB, EBAA, OSHA and other relevant federal, state, and local regulatory entities.
Responsible for facilitating and directing all inspections at DNA.
Collaborates with Executive Leadership Team and Department Directors to initiate and maintain accreditation status with applicable professional trade agencies and licenses with regulatory agencies
Responsible for facilitating and directing all inspections at DNA.
Serves as a liaison to tissue processors, hospitals, etc. as it relates to regulatory compliance and quality matters in collaboration with applicable Department Directors and others.
Monitors and analyzes information release and activity pertaining to federal, state and industry standards as it relates to regulatory compliance and organizational operation.
Partners with Vice President of Development and Referral Services and others on legal, regulatory, and legislative affairs on quality and compliance topics.
Directs and provides education of organizational and departmental staff regulatory and accreditation topics, processes, methods, etc.
Directs and provides technical support services, guidance, and internal consulting on regulatory and compliance processes and projects.

Risk Management
Responsible for working with DNAs legal counsel to address legal issues such as subpoenas, contracts, occurrences with associated vendors/suppliers, etc. and other legal inquiries or potential risk issues.
Ensures processes are undertaken and formalized with the goal of mitigating risk to the organization.
Assists in the review of contracts to ensure quality standard and other requirements are cascaded as appropriate.
Participates in evaluating insurance coverage needs for risk mitigation in relation to quality, compliance, professional, and other areas of potential liability.
Responsible for ensuring that a Business Continuity Plan is implemented that meets the regulatory requirements and needs of Donor Network of Arizona.

Performs related duties, responsibilities, and projects as needed and/or assigned.

Qualifications:

Minimum Education
Bachelors degree

Minimum Experience
8 years of related experience in tissue recovery, tissue processing, organ donation, organ transplant services, Pharmaceutical, Biomedical, Healthcare, and/or related field.
5 years Director or higher level experience leading quality assurance and quality systems in similar industry.

Preferred Education
Masters degree in life sciences, healthcare, engineering, operations research, human factors, quality systems, and/or related field.
Quality Certification: Six Sigma Black Belt, Baldridge Fellow, ASQ and/or other quality related certification and/or credential
Certified Professional in Healthcare Quality (CPHQ); Certification in HealthCare Quality and Management (HCQM)
Quality Process Analyst Certification (CQPA); or Certified in Healthcare Quality (CHQ)
Certified Quality Engineer (CQE)
Certified Manager of Quality/Organizational Excellence (CMQ/OE)
Certification within Transplant Services Field (i.e. Certified Tissue Bank Specialist or Certified Transplant Procurement Coordinator)
Project Management Certification (i.e. PMP and/or Agile)

We Offer:
Organizational Incentive Program Annually
Very Generous Medical, Dental & Vision Insurance
Paid Life Insurance and LTD Insurance
Voluntary Life Insurance options
403b employer match and profit sharing
Generous Tuition Assistance Program
Employee Assistance Program
Employee Wellness Program
Tobacco Free Workplace?

Donor Network of Arizona is a drug free workplace.