About The Position
Are you a detail-driven quality professional with a passion for advancing life-saving therapies? We’re seeking a Senior Quality and Accreditation Coordinator to lead and elevate the quality and regulatory efforts across our Bone Marrow Transplant (BMT) Program, Immunotherapy and Gene Therapy Services, and Therapeutic Apheresis. In this pivotal role, you will oversee our quality management and regulatory compliance programs, ensuring alignment with standards from FACT, FDA, NMDP, TJC, AABB, CDPH, and CIBMTR. You’ll work in close partnership with the Laboratory Quality Assurance Manager and multidisciplinary teams to guide all aspects of cell processing—from apheresis and marrow collection to laboratory operations—ensuring full compliance with all regulatory and accreditation requirements. We’re looking for an experienced quality leader who brings: • A deep understanding of regulatory and accreditation standards in cellular therapy and BMT • A commitment to continuous improvement and patient-centered excellence • Strong collaboration, communication, and organizational skills • A passion for innovation in cellular therapies and their potential to transform outcomes Join us and be part of a mission-driven team at the forefront of cellular therapy, where your expertise will directly impact the quality and safety of some of the most advanced treatments in medicine.
Requirements
- Minimum two years of experience in clinical data management, healthcare quality, hematology/oncology, or cellular‑therapy programs.
- Bachelor’s degree in health science, nursing, biological sciences, or related field.
- Proficiency in quality systems and regulatory standards (FDA 21CFR 200, 210, 600, 1271; FACT; NMDP; AABB). Strong knowledge of oncology/stem cell transplant terminology, infectious disease testing, transplant outcomes, and data management.
- Excellent organizational, written, verbal, and interpersonal communication skills.
- Strong knowledge of document control systems for managing, editing and publishing standard operation procedures.
- Project management and presentation capabilities.
- Intermediate to advanced skills in Microsoft Office and electronic documentation systems.
- One of the following: CLS, MLT, CABP (AABB), or CA Registered Nurse.
Nice To Haves
- Oncology/Hematology, three years of BMT lab processing experience or other relevant clinical experience.
- Current or previous experience as an assessor for the Foundation for Accreditation of Cellular Therapy.
- Master’s degree in Science, Nursing, Laboratory Science, Business or closely related field.
- Advanced knowledge of Current Good Tissue Practices (cGTP) and Current Good Manufacturing Practices (cGMP). Including point-of-care manufacturing.
- Intermediate to advanced knowledge of cell therapy clinical and translational research trials.
- CA Registered Nurse license or CQA(ASQ)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
