Quality Systems Manager

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.

The Quality Systems Manager is responsible for developing, implementing, and maintaining a comprehensive Quality Management System (QMS) to ensure compliance with regulatory, accreditation, and industry standards. This role oversees quality assurance activities, internal and external audits, continuous improvement initiatives, and cross-functional training programs. The incumbent will be expected to work with project teams as a quality representative to support clinical development programs. In addition, the individual will work with project teams to ensure clinical studies and supporting activities are conducted in compliance with GxP. The QS Manager will ensure timely completion of record review, SOP revision, deviation management and tracking along with hosting and performing external and vendor audits.

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Design, implement, and maintain QMS policies, procedures, and documentation to ensure compliance with applicable standards (e.g., ISO 9001, CLIA, CAP, DOH, SOC2).
• Oversee document control systems, ensuring proper versioning, approval workflows, training assignments, and annual reviews.
• Serve as Business System Owner or stakeholder for quality-related systems such as QMS platforms, Laboratory Information Management Systems (LIMS), and Electronic Laboratory Notebooks (ELN).
• Partner with stakeholders to define system requirements and support validation activities for LIMS/ELN and other regulated software.
• Plan, conduct, and report internal audits to assess compliance with organizational procedures and external regulations.
• Prepare, facilitate and report audits against CAP/CLIA/NYS CLEP regulations and ICH guidance documents.
• Coordinate external audits, regulatory inspections, and accreditation assessments, ensuring readiness across departments.
• Communicate compliance risks to senior management.
• Champion proactive identification and resolution of compliance gaps.
• Create additional quality system programs as required.
• Maintain and continuously develop the QA procedures for phase appropriate compliance with CAP, NYS CLEP, FDA other applicable regulations.
• Support facility improvement projects.
• Perform routine quality assurance responsibilities including review and approval of records, deviation investigation reports, document change requests, CAPAs, and Standard Operating Procedures.

MINIMUM QUALIFICATIONS:

• Minimum of 7 years working in a Quality role within a clinical molecular laboratory.
• Experience working in a regulated CLIA environment.
• Knowledgeable with FDA IDEregulations and guidelines.
• MLS (ASCP)

PREFERRED QUALIFICATIONS:

• Ability to initiate and develop strategic initiatives in combination with Molecular Oncology leadership.
• Ability to utilize elements of Quality Risk Management to manage and control risk.
• Good listening skills, interpersonal savvy, and peer relations.
• Ability to effectively present complex data and strategy to large groups.
• Ability to work as a team member and to work collaboratively with strong listening skills.
• Ability to take strategic initiatives and translate into tactical solutions.
• Experience in developing or leading teams.
• Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.
• Independently identify and resolve complex problems through good decision quality utilizing functional and technical skills.
• Manage conflict and stand alone on issues.

The hourly pay range for this position is from $61.05 to $96.48 and pay offered will be based on experience and qualifications.

Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks). Paid time off is prorated for part-time positions.