Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutchs pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.
The Quality Lab Operations Manager provides leadership and direction for the Molecular Oncology lab, including training and managing staff, maintaining CLIA regulatory documents and preparing for internal and external audits. This position is also responsible for participating in the development, implementation and maintenance of quality assurance and regulatory compliance activities related to Fred Hutch Clinical Testing Labs.
The Quality Lab Operations Manager will lead the clinical team in maintaining and monitoring the comprehensive quality program in support of clinical laboratory testing. In additional to overseeing Quality and Compliance within the clinical testing labs, the individual also directly supervises and oversees personnel and testing within the Molecular Oncology lab.
Collaborates with the Medical Director and Clinical Supervisors to develop laboratory policies, systems, standard operating procedures and study-specific protocols for laboratory operations, ensuring compliance with quality, regulatory and other applicable guidelines to maintain CLIA/CAP regulatory licensures for Fred Hutch
Manages clinical trials and research studies from the perspective of a central testing site
Facilitates CLIA/CAP and other regulatory and compliance meetings, inviting external speakers, leading quality discussions and overseeing quality programs across the clinical testing labs
Supervise Molecular Oncology laboratory staff including hiring, training, ongoing competency assessment, handling disciplinary action, layoff and termination issues
Directs and reviews results from Proficiency Testing external exchanges and CAP surveys to ensure testing personnel competency and overall lab quality
Maintains personnel files for lab testing personnel, including training, proficiency testing, annual competency evaluation, and continuing education
Maintain an effective document control system for proper initiation, training, annual review and retirement of documents, policies and SOPs
Coordinator and primary contact for internal and external regulatory audits
Oversees laboratory operations, providing guidance and taking corrective actions through CAPAs and Continual Process Improvement projects
Establishes, reviews and approves QA/QC monitoring mechanisms to ensure that test procedures and results are performed, recorded, and reported promptly, accurately and proficiently
Ensures operational compliance with and performs comprehensive annual review of Quality Management system, policies and program
Participates in long-term planning of laboratory operations including anticipation of staff, equipment and space needs, financial goals, and capacity planning
Communicates with clinicians regarding test requests, specimen handling, results and interpretation
Maintains a thorough understanding of the laboratorys scope of service and goals; participate in determining long range goals for individual projects as well as the overall CLIA program
Works collaboratively with various internal and external departments (including EH&S, HR, IT) to ensure operational success of the CLIA laboratories and related activities
Establishes and maintains a continuing education program to educate staff on new or revised APOPs, new laboratory techniques and departmental policies and procedures
Subject Matter Expert (SME) in the Lab Information Management System, supporting and leading change controls, validations and User Acceptance Testing
May also perform moderate and high complexity molecular testing in a CLIA-regulated lab
Bachelors Degree in the field of Laboratory Science or equivalent
Minimum 5 years lab management experience, including managing non-waived laboratory testing in a CLIA lab
Certified by the American Society of Clinical Pathologists (ASCP) as a Medical Laboratory Scientist (MLS)
Thorough understanding of regulations applicable to a CLIA laboratorys operations; experience with CLIA/CAP inspections; experience in assay validation, writing/revising SOPs, quality/compliance standards and CPI
Experience in molecular pathology methods that qualify as high complexity testing
Demonstrates leadership skills in a laboratory setting
Oral and written communication skills, with all levels of personnel
Demonstrated success with Process Improvement Projects
Successful validation and implementation of New Assays and Instruments
Personnel management in a CLIA/CAP environment
Compliance and regulatory experience with DOH, CLIA, CAP
Proficient in running a QM program
Experience in management of personnel and development of proficiency testing systems
Document control: developing procedures, maintaining and implementing a document control system
Regulatory inspections and Third-party client audits
Deviation and CAPA reporting
Quality metrics, trending
Change control, Validation of LIMS
Document and archive management
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through work at Fred Hutch is requested of all finalists.
Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at email@example.com or by calling 206-667-4700.
At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.