Technical & Compliance Laboratory Manager

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

Works independently under the guidance of and in conjunction with the laboratory leadership in accomplishing the goals of the laboratory. The Technical & Compliance Manager will work in collaboration with the Alliance Lab Director, the lab medical director(s), the Testing Manager, and the Quality Senior Manager to complete initiatives, complex troubleshooting, and systems upgrades/updates in a timely manner and within the appropriate regulatory compliance expectations. The Technical & Compliance Manager is the primary point of contact for real-time support for instrument, calibration, and quality control troubleshooting.

This role is primarily based at the South Lake Union campus (825 Eastlake Ave. E, Seattle, WA). This role also oversees and occasionally travels to our community site labs at:

• Evergreen Healthcare (12040 NE 128th St, Suite Silver 1600 Kirkland, WA)
• Peninsula Clinic (19917 Seventh Ave. NE, Suite 100 Poulsbo, WA)
• Overlake Medical Center (1135 116th Ave NE, Suite 250 Bellevue, WA)

1.0 FTE - Exempt Role

Responsibilities

• Responsible for technical performance and regulatory compliance of laboratory testing in all Alliance Labs at South Lake Union (main lab and satellite labs), Evergreen, Peninsula, and all future community site Alliance Lab locations. Oversight includes validations, QA/QC, and technical compliance.
• Lead test/system evaluation, troubleshooting, process design, and development.
• Oversee, maintain, and sign off on regulatory required activities including quality control, maintenance, calibrations, correlations, and peer quality control reviews.
• Develop leadership reporting structure to clearly manage and demonstrate compliance with regulatory required activities.
• Write policies and procedures for test systems, evaluate existing policies and procedures, and oversee the implementation and management of lab policies and procedures.
• Provide oversight and direction to projects including installations, new/expanding labs, new software systems, and other replacements and new methods.
• Direct the day-to-day work of the Technical Specialists ensuring work is completed on time and in line with policies/procedures and accrediting agency requirements.
• Lead and participate actively in QA/QM programs and projects for all Alliance Lab locations. Act as a resource and mentor to lab leaders and lab team members regarding regulatory compliance.
• Oversee and maintain an effective hematology education program ensuring internal non-traditional lab techs are prepared for hematology certification, a key to strengthening and stabilizing our lab tech workforce.
• Support the development and maintenance of adaptable laboratory systems to meet evolving clinical research needs.
• Collaborate on the strategic planning and implementation of infrastructure, workflows, and financial models that facilitate clinical research activities within the laboratory.
• Assist Principal Investigators and research administration teams in aligning scientific goals with operational capabilities, fostering coordination and project success.
• Provide training and guidance on clinical laboratory processes, procedures, and regulatory compliance, as needed.

1.0 FTE - Exempt role - Monday through Fri - 8a-5p Onsite -This position is based out of the South Lake Union campus (May help cover our Satellite labs as needed)

Qualifications

Required:

• Bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution or a Bachelor's degree and equivalent education and training as defined in 42CFR493.1489(b)(3).
• Certification as Medical Laboratory Scientist, Medical Technologist, or an equivalent certification with certified maintenance of continuing education through ASCP, AMT, or AAB.
• Certification as a CAP Inspector Team Member is required within 6-months of hire.
• 4 years of laboratory experience performing testing on human samples required.
• Abilities to effectively communicate verbally in person, on the phone, and in writing in a clear, concise, and professional manner.
• Attention to detail with ability to work in a high-pressure, time-sensitive, and complex healthcare environment.
• Proficiency and experience interpreting and applying applicable lab regulations and requirements.
• Proficient with MS Office Suite.
• Demonstrated ability to lead others through influence and diplomacy.
• Strong project management skills.
• Must be able to differentiate between colors and pass a standardized color vision screen to perform this role.

Preferred:

• Master's degree in lab science, healthcare administration, business, or related field.
• At least 4 years of laboratory training or experience, or both, in high complexity testing in hematology and/or chemistry (2 years for employees with Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution). Meets the CLIA training and experience requirements for a high complexity general supervisor, technical consultant, and technical supervisor in hematology and/or chemistry.
• Familiarity with clinical research processes and their application in clinical laboratory settings is beneficial.

The annual base salary range for this position is from $120,932.00 to $191,131.00, and pay offered will be based on experience and qualifications.

1.0 FTE - Exempt role - Monday through Fri - 8a-5p Onsite -This position is based out of the South Lake Union campus (May help cover our Satellite labs as needed)