Work Location
Orange, California
Work Shift
Day - 08hrs (United States of America)
Why CHOC?
At CHOC, we strive to be the leading destination of children's health by providing exceptional and innovative care. We are responsible for the overall health of our community's pediatric population in our hospitals, clinics, and practices. And because of our breadth of care, your career at CHOC can be as diverse and fulfilling as you determine. CHOC's compensation structure, benefits offerings, and career development programs are geared to helping you achieve your professional and personal goals. Apply now to see where your career at CHOC can take you.
Job Summary
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.
Pay Range
Minimum $86,258 Midpoint $114,296 Maximum $142,334
Rate of pay is determined by various factors, including but not limited to knowledge, skills, competencies, experience, education, as well as position requirements.
Experience
* Required: Minimum five years of experience in the field of cellular therapy Regulatory Compliance and Quality Management, three of which should be in the role of supervisor or manager of a cell therapy program, collection facility, or processing facility.
* Preferred: 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.
Education
* Required: Bachelor's degree in health science or biological sciences. Equivalent experience in BMT regulatory or quality management may be accepted in lieu of health science or biological science specific degree
* Preferred: Master's degree in Science, Nursing, Laboratory Science, Business or closely related field.
Special Skills
* Required: Excellent organizational, written, verbal and interpersonal communication skills; good presentation and project management skills;
proficient in computer software applications. Must have knowledge of FDA, specifically 21CFR 200, 210, 600, and 1271, AABB, FACT, NMDP regulations/guidelines and accreditation requirements. Working knowledge of oncology/stem cell transplant medical terminology, Working knowledge of CIBMTR compliance, audits and data management. Must have an intermediate to advanced knowledge of transplant, infectious disease testing (other transplant workup) and transplant outcomes as well as an increasing functional knowledge of Blood and Marrow diseases.
* Preferred: 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.
Licensure
* Required: CLS, MLT, CABP(AABB) or equivalent
* Preferred: CA Registered Nurse license or CQA(ASQ)
Work Environments - Functional Demand:
Light - Moderate energy level Lift and carry 25-35 lbs. Push/pull 50-100 lbs. (ie. empty bed, stretcher).
Physical Activity Requirements:
Bending, Carry Objects, Climbing, Keyboard use/repetitive motion, Pinching/fine motor activities, Push/Pull, Reaching forward, Reaching overhead, Sitting, Squat/kneel/crawl (Squad & Knee), Standing, Talk or hear, Taste or smell, Twisting, Walking, Wrist position deviation
Physical Activity Lifting
Lifting (Floor to waist level) - Occasional 0-35%, Lifting (Waist level and above) - Occasional 0-35%
Sensory Requirements:
Color Discrimination, Depth Perception, Far Vision, Hearing, Near Vision
Environment Requirements:
Airborn Communicable Disease, Bloodborne Pathogens, Chemical, Dust Particular Matter, Extreme Noise Levels, Extreme Temperatures, Radiation, Uneven Surfaces or Elevations
Non-Discrimination Statement:
CHOC does not discriminate on the basis of age, race, color, religion, national origin, ancestry, marital status, genetic information, disability, sex, gender (including pregnancy, breastfeeding, childbirth, lactation or related medical conditions), gender identity or expression, medical condition, sexual orientation, veteran status, military or uniformed service member status, or other protected characteristics in accordance with state and federal laws.
We encourage individuals from all backgrounds to apply for positions at CHOC, even if your experience doesn't align perfectly with the listed qualifications for a particular role, as your unique experience may be a great addition to our culture for another one of our opportunities.
If you desire support or accommodations throughout the Talent Acquisition process, please inform your Talent Acquisition Partner.
