Quality & Regulatory Affairs Manager
Job posting number: #7117328 (Ref:10019428)
Posted: December 6, 2022
Application Deadline: Open Until Filled
About City of Hope
City of Hope is an independent biomedical research and treatment organization for cancer, diabetes and other life-threatening diseases.
Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope™, a subsidiary launched in 2019 serves employers and their health care partners by providing access to City of Hope’s specialized cancer expertise.
A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.
City of Hope’s commitment to Diversity, Equity and Inclusion
We believe diversity, equity and inclusion is key in serving our mission to provide compassionate patient care, drive innovative discovery, and advance vital education focused on eliminating cancer and diabetes in all of our communities. Our commitment to Diversity, Equity and Inclusion ensures we bring the full range of skills, perspectives, cultural backgrounds and experiences to our work -- and that our teams align with the people we serve in order to build trust and understanding. We are dedicated to fostering a community that embraces diversity - in ideas, backgrounds and perspectives; this is reflected in our work and represented in our people.
Plans, coordinates, and leads all areas of the Department of Pathology at Lennar Foundation Cancer Center in activities related to quality, and compliance/regulatory affairs.
Key Responsibilities include:
Provides oversight and leadership of all quality management activities carried out in all areas department of Pathology at Lennar Foundation Cancer Center (LFCC). Provides guidance to the in regard to meeting the requirements of regulatory and accrediting agencies for the Pathology Department. Demonstrates a level of working knowledge of the following agencies (as appropriate):
- Food and Drug Administration (FDA)
- California Department of Public Health (CDPH)
- Center for Medicare and Medicaid Services (CMS).
- Joint Commission (JC)
- AABB (formerly American Association of Blood Banks)
- College of American Pathologists (CAP)
- Foundation for Accreditation of Cellular Therapy (FACT)
- National Marrow Donor Program (NMDP)/Be The Match (BTM)
Compliance and Regulatory Affairs
- Provides a review, interpretation, and assessment of the effect of all new, and revised regulations, standards, guidelines, etc. from regulatory and accrediting agencies on laboratory medicine.
- Reviews and approves of all operational policies and procedures in Department of Pathology in collaboration with quality colleagues, operational managers and supervisors, medical directors and laboratory operations director.
- Takes appropriate actions related to error/accident/event investigation, tracking, reporting, and follow-up.
- Reviews and approves of all equipment, process, and system validation activities.
- Assists areas with the development of validation plans and documents appropriate for the process/equipment being validated, and provides assistance with data analysis, as needed.
- Provides reports to external regulatory/accrediting agencies as required.
- Maintains, reviews and modifies the Department of Pathology quality management program as needed
- Leads the Pathology department’s QA committee and serves as a member of other institutional quality and ad hoc committees as designated by the Laboratory director.
- Performs quality audits and other ongoing assessments of operations, and work on performance improvement activities.
- Responds to second-party site visits and audits.
- Facilitates appropriate change management activities within the Pathology Department in response to new and/or revised regulatory or accrediting agency requirements.
- Participates in interdisciplinary teams on process improvement.
- Maintains an adequate understanding and working knowledge of principles and techniques used in blood and cellular therapy product collection and processing in order to apply quality management practices to these activities.
Licensing and Accreditation
- Serves as the Department of Pathology primary contact and liaison with all external regulatory and accrediting agencies.
- Maintains appropriate licenses and certifications required for all laboratory sections in LFCC and the Orange County Coastal Network clinic laboratories.
- Assists in preparing, coordinating and following up on all inspections and provides reports and requested information for all agencies.
- Assists management with budget planning, contracting, and ongoing expense monitoring.
- Information Systems
- Collaborates with laboratory staff on the evaluation, proper use of, and development of the laboratory’s LIS system.
- Monitors the proper integration of transfusion medicine information systems with laboratory and hospital information systems.
Basic education, experience and skills required for consideration:
- Bachelor of Science degree.
- 5+ years of experience in quality assurance and regulatory environments.
- California license as a Clinical Laboratory Scientist.
Preferred education experience and skills:
- MT/CLS – MLS (ASCP).
- CAP Inspector.
- ASQ CMQ/OE.
- As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
City of Hope is a community of people characterized by our diversity of thought, background and approach, but tied together by our commitment to care for and cure those with cancer and other life-threatening diseases. The innovation that our diversity produces in the areas of research, treatment, philanthropy and education has made us national leaders in this fight. Our unique and diverse workforce provides us the ability to understand our patients' needs, deliver compassionate care and continue the quest for a cure for life-threatening diseases. At City of Hope, diversity and inclusion is a core value at the heart of our mission. We strive to create an inclusive workplace environment that engages all of our employees and provides them with opportunities to develop and grow, both personally and professionally. Each day brings an opportunity to strengthen our work, leverage our different perspectives and improve our patients’ experiences by learning from others. Diversity and inclusion is about much more than policies and campaigns. It is an integral part of who we are as an institution, how we operate and how we see our future.