The Director of Operations Quality for the HSCT & Cellular Therapies Program provides leadership and direction to ensure operational excellence across a broad range of activities and sites for one of the largest and most respected HSCT and Cellular Therapies programs in the U.S. Working collaboratively with faculty and staff to develop and implement strategies to achieve programmatic excellence, this highly visible position will rely on a deep understanding of clinical operations in a large and highly complex care delivery system to successfully build and socialize methods to optimize effective operations. The Director will serve as a key leader for programmatic interests in overall operational effectiveness and innovative solutions that ensure patient safety, regulatory compliance, clinical templates and electronic and other tools to support improvements in utilization and outcomes, documentation that supports revenue integrity, business planning, and outcomes reporting, well-engineered day to day workflows, positive and supportive interface with regulatory organizations, effective working relationships with commercial organizations to implement new products, development of programs to ensure staff readiness and training, and process improvements that support financial performance. The Director will serve as key consultant and provide guidance to other programmatic leads across sites of care including inpatient and outpatient clinical operations, institutional facilities teams, clinical and cell processing laboratories, patient coordination, donor services, community-based care and referring physician relations, business analytics, financial planning and strategic planning. Managing a team of approximately 20 staff members, including quality assurance and improvement managers and specialists, outcomes reporting and program administrators, and an audit team, the Director reports to the VP for the HSCT & Cell Therapies service line for adult and pediatric programs.
The Director is a key member of the clinical leadership team working closely with the Medical Directors providing consultation and guidance to all staff involved with the care and coordination of patients in the program. Will provide advisory and informational support to administrative leadership and other institutional executives and officials across the sites of care relative to transplant and cellular therapy operations quality and will play a leading role in communicating and educating all institutional staff as needed regarding standards and operational methods necessary to comply with such standards.
The Director is responsible for overseeing and managing the patient safety and quality management program, ensuring suitable regulatory compliance methodology and documentation, continuous quality and process improvement, outcomes reporting, and global education across the organizations. The Director ensures full integration of the program’s quality systems with the organization’s patient safety and risk management enterprise, and serves as the key quality contact for the program for other leaders in the institution. The Director will oversee the program’s clinical outcomes data enterprise including reporting to the national repository and meeting regulatory requirements for data quality, be expected to lead or support quality research and improvement initiatives internally and as a representative of the organization for national or multi-site quality projects.
Working closely with clinical staff, duties include oversight of the development, updating and dissemination of standard operating procedures for clinical practices that fall under regulatory control, for monitoring and reporting on stem cell transplantation and other cell therapy clinical key indicators, performing and managing responses to clinical process audits, and managing planned and unplanned deviation reporting and trend analysis. Directing the efforts of two quality managers and a quality assurance team, the Director will oversee the coordination of FACT, FDA, JC, AABB, and other relevant compliance reporting and reaccreditation and inspection readiness requiring a full understanding of all relevant quality standards, ensuring that all regulatory and internal outcomes driven operating procedures are implemented and tracked. The Director will support clinical leadership in the development of treatment plans, consents and forms as needed to ensure structured clinical practices. The Director will be expected to appropriately direct and support the quality managers or personally participate contemporaneously in deviation and adverse event documentation and assessment and play a lead role in subsequent root cause analysis and corrective action.
The Director will play a lead role in the development of uniform training standards, procedures and documentation of competencies for all staff engaged in the coordination and care of transplant and cell therapy patients and donors. The Director organizes, plans and moderates various committee meetings and presents quality outcomes and goals as needed.
A bachelor’s degree is required plus a minimum of 8 years of experience in a role of management responsibility in a clinical operations setting that includes some experience working with quality management and regulatory affairs. A relevant higher degree is highly preferred and may offset up to two years of required experience. Previous experience is preferred in an oncology clinical setting, blood bank/hematology system, stem cell transplant or cell therapies program or other relevant setting.
Successful supervisory experience is required.
Demonstrated interest in operational effectiveness and innovative solutions to achieve excellence throughout complex care delivery systems.
Strong demonstrated ability to develop formal and informal networks and collaborative working relationships across multidisciplinary specialties and sites of care will be considered key to success in this role.
Ability to assess, embrace and leverage institutional cultural and knowledge strengths will be important to success.
Must have demonstrated ability to lead teams to perform work in a compliant and quality focused manner.
A background with financial planning and performance and business analytics is strongly preferred to enable rational development of operational models that support both quality and efficient resource utilization.
Demonstrated ability to supervise and ensure training and preparation of staff working as a team to perform within complex workflows and to lead staff through challenging change management and quality improvement implementation.
Should have experience leading the development and implementation of effective and appropriate communication plans, such as for disseminating process, system or rule changes across a large and multidisciplinary staff.
Must be knowledgeable of general clinical regulatory principles; solid knowledge of FACT, FDA, AABB, and JC regulations is strongly preferred.
Must have clinical database conceptual understanding for overseeing outcomes reporting and analysis and other regulatory reporting, for organizing information in a useful manner; must be willing to gain competence in the use of institutional clinical information and health record systems.