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Posted: 04-Feb-26
Location: Durham, North Carolina
Categories:
Internal Number: 265582
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 the four Duke Healthhospitals with 1062 patient beds, it features comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more.
Duke Nursing Highlights:
- Duke University Health System is designated as a Magnet organization
- Nurses from each hospital are consistently recognized each year as North Carolina's Great 100 Nurses.
- Duke University Health System was awarded the American Board of Nursing Specialties Award for Nursing Certification Advocacy for being strong advocates of specialty nursing certification.
- Duke University Health System has 6000 + registered nurses
- Quality of Life: Living in the Triangle!
- Relocation Assistance (based on eligibility)
Work arrangement - onsite - North Pavilion, 8th floor
At Duke Health, we're driven by a commitment to compassionate care that improves the lives of patients, their loved ones, and our community. We invite you to bring your expertise to a collaborative environment where we advance health together
POSITION SUMMARY
The Strategic Services Associate (SSA) will support the Adult and Pediatric Bone Marrow Transplant clinical quality programs (APBMT CQP). This role serves as a quality and regulatory liaison for one primary operational area: Stem Cell and Cellular Therapy Laboratory (STCL), Apheresis, or Clinical Operations, with cross-coverage responsibilities as needed. The SSA plays a key role in ensuring compliance, product quality, and continuous improvement across adult and pediatric cellular therapy programs.
KEY RESPONSIBILITIES
Quality & Regulatory Compliance
- Maintain compliance with Foundation for the Accreditation of Cellular Therapy (FACT), Duke Health, FDA, and commercial partner requirements for adult and pediatric BMT cellular therapy programs and the Stem Cell Laboratory (STCL)
- Support FACT accreditation activities, including annual reporting and triennial inspections
- Support CAP (College of American Pathology) inspection preparation, onsite activities, and closure processes for the STCL (every 2 years)
- Support during other inspections, as deemed necessary
Daily Operations & Product Release
- Assist in quality supply inspection and cellular product release
- Perform Urgent Medical Need (UNM product) review/release
- Conduct review of facility logs and records (ie. monthly, quarterly, etc)
- Review and approve Deviations, Investigations, Corrective Actions, Complaints, and Adverse Events for clinical programs
- Participate in audits pertaining to clinical, stem cell, or apheresis activities as identified by the department
Change Control & Validation
- Review, approve and initiate Change Control Records (CCRs) in the document control system MasterControl
- Initiate CCRs as needed for document, software, equipment, or facility changes
- Provide guidance on CCR initiation and completion requirements
- Provide guidance when completing risk assessments
- Review, draft, and approve validation plans and reports
Committee & Reporting
- Support in APBMT Quality Assurance Committee meetings
- Organize, track, trend, and report quality metrics to leadership and QA committee
Minimum Qualifications
Education
Bachelors degree in a business or health-related field is required. Master's degree preferred
Experience
- Minimum of 5 years work experience
- 3 years of experience with significant quality/regulatory compliance or process improvement responsibility in a clinical laboratory or healthcare setting.
- Experience leading work teams required.
Knowledge, Skills and Abilities
- Effective written and verbal communication skills.
- Ability to communicate with customers/staff with diverse educational backgrounds.
- Analysis of data and processes for opportunities for improvement.
- Ability to manage numerous diverse projects simultaneously through effective priority setting, efficient use of time, organization
- Knowledge of accreditation standards and regulations related to health care
- Attention to detail and accuracy.
- Computer literacy
Preferred Qualifications
- Regulatory Knowledge: FACT standards, FDA regulations (21 CFR Part 1271), cGMP/cGTP requirements, and CAP standards
- Clinical Experience: Stem cell processing, apheresis, BMT, or cellular therapy operations
- Quality Systems: Proficiency with MasterControl or similar quality management systems
- Technical Skills: Microsoft Office Suite (Excel, Word, PowerPoint), FDA reporting systems (BPDR)
- Analytical Skills: Root cause analysis, risk assessment, CAPA development
- Communication: Strong written/verbal skills for regulatory agencies, sponsors, clinical staff, and committees
- Organizational Skills: Ability to manage multiple priorities, inspection timelines, and interdependent processes
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 on the 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.
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.