Clinical Quality Program Manager

At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.

About Duke University Hospital

Pursue your passion for caring with Duke University Hospital in Durham, North Carolina, which is consistently ranked among the best in the United States. The largest of Duke Health's four hospitals with 1062 patient beds, it features comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more.

Position Summary

Under the Duke Cancer Institute (DCI) Quality structure, the Clinical Quality Program Manager provides administrative and strategic leadership for the Adult & Pediatric Blood and Marrow Transplant (APBMT), Cell Therapy, and Gene Therapy programs. The role manages and coordinates all quality‑ and safety‑management services; ensures continuous regulatory compliance; upholds Duke’s accreditation with the Foundation for the Accreditation of Cellular Therapy (FACT); and oversees quality frameworks for Clinical Apheresis, the Stem Cell Laboratory, and related clinical operations. Reporting to the DCI Administrative Director for Oncology Quality & Safety, the manager also leads special initiatives—speaker series, publications, conferences, and payor/manufacturer showcase events—to advance program objectives.

Core Functions

• Coordinate and lead strategic meetings with faculty and stakeholders to set program objectives and secure the resources required to achieve them.
• Develop, implement, and maintain program SOPs, protocols, and operating policies; prepare FACT re‑accreditation applications; and maintain year‑round audit readiness.
• Collaborate with CIBMTR data teams to ensure data quality, accuracy, and audit readiness; design internal audit tools, schedules, and corrective‑action plans.
• Oversee third‑party agreements and SOP reviews while verifying staff credentials and ongoing competency.
• Prepare and submit grant and contract proposals in compliance with University and sponsor requirements, including record‑keeping and reporting.
• Plan and execute high‑profile events and special programs, such as accreditation site visits, inspector itineraries, speaker series, and showcase conferences.
• Develop and disseminate educational and communication materials (e.g., inspection itineraries, training manuals, bulletins, newsletters) that highlight quality goals and achievements.

Data Oversight & Reporting

• Lead capture, analysis, and reporting of transplant and cellular‑therapy data to support decision‑making and continuous improvement.
• Streamline tumor‑registry workflows, leveraging automation to improve data‑collection efficiency and reduce costs.
• Share performance dashboards and quality metrics across DCI and partner institutions.

Quality & Safety Program Management

• Direct quality and patient‑safety initiatives across clinical divisions, departments, and disease‑site programs.
• Provide data driven support to clinical leadership for quality‑ and safety‑outcome accountability.
• Supervise supply chain quality checks and qualification processes.

Policy & SOP Management

• Maintain a robust, version‑controlled Standard Operating Procedure library aligned with current regulations and best practices.
• Facilitate policy reviews and updates in collaboration with cross‑functional stakeholders.

Incident & Risk Analysis

• Investigate incidents, sentinel events, and variances; conduct root‑cause analyses; and coordinate corrective and preventive actions (CAPAs).
• Develop annual audit schedules, perform internal audits, track Key Performance Indictors (KPI), and report trends to leadership and quality committees.
• Implement systems that minimize variation and eliminate error sources.

Process Integration & Best Practices

• Champion standardization and integration of clinical processes across DCI.
• Lead adoption of best practices and advanced data systems to enhance safety, outcomes, and data integrity.

Value‑Based Care & Strategic Planning

• Partner with Duke University Health System insurance division to implement oncology value‑based‑care initiatives and lead Centers for Medicare & Medicaid Services (CMS) value‑based programs.
• Recommend strategic goals, monitor progress, and guide budget development in line with institutional priorities.

Education & Competency

• Design and deliver training on FACT standards, Food and Drug Administration (FDA) requirements, and continuous‑improvement methodologies.
• Ensure timely competency assessments and remediation plans for all program staff.

Collaboration & Communication

• Serve as liaison among clinical teams, apheresis, cell processing, and administrative leadership.
• Lead quality‑committee meetings, document outcomes, and ensure transparent communication of quality objectives and results.

Regulatory Compliance & Accreditation

• Ensure continuous compliance with federal, state, and institutional regulations and accreditation standards (FACT, FDA, The Joint Commission, CMS).
• Prepare documentation for inspections and audits; lead gap analyses, mock inspections, and readiness drills.

Experience

• Work requires the ability to plan and administer programs and direct program activities within a specific functional area, generally acquired through four years of related experience. Preferred (3) years of patient‑safety or quality‑management roles, preferably within cellular‑therapy or oncology settings. OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
• Demonstrated knowledge of FACT‑JACIE Standards, Good Manufacturing Practice (GMP)/Good Tissue Practice (GTP), FDA, TJC, and CMS regulations.
• Preferred 2 years of management experience or equivalent leadership of large‑scale projects.
• Proficiency with complex healthcare data sets, analytical tools, and database applications.
• Solid grounding in Lean or other process‑improvement methodologies.

Education & Certification

• Bachelor’s degree in Nursing, Healthcare Administration, Clinical Laboratory Science, or related field (Master’s preferred).
• Preferred 3–5 years of experience in healthcare quality, oncology, or cellular‑therapy programs (FACT experience strongly preferred).
• Preferred certifications: Certified Professional in Healthcare Quality (CPHQ) and/or Certified Professional in Patient Safety (CPPS).

Skills & Abilities

• Proven ability to juggle multiple priorities and complex projects.
• Strong leadership, facilitation, and team‑building skills.
• Excellent analytical, problem‑solving, and project‑management capabilities.
• Exceptional written and verbal communication skills.
• Service‑oriented mindset with flexibility to meet diverse stakeholder needs.

Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends onthe robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.