Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch's global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Based in Seattle, 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 for the world's deadliest diseases and make life beyond cancer a reality.

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.

Under the general direction of the Accreditation and Regulatory Manager:This role will work in a collaborative fashion across the Fred Hutchinson Cancer Center, Seattle Children's Hospital, and The University of Washington to measure, monitor and improve the quality of care and accreditation compliance for FHCC's Blood & Bone Marrow Transplant and Immunotherapy Programs under guidance and leadership from the Quality Program Manager. They manage the portfolio of Quality activity for the BMT and IMTX programs and ensures a cohesive and complete approach by partnering with the following Quality teams: CTP Quality, Patient Safety, Infection Prevention, Patient Experience and Accreditation & Regulatory Affairs (ARA). This role will work very closely with ARA, to ensure continuous compliance with primarily the Foundation for the Accreditation of Cellular Therapy (FACT), but also the Food and Drug Administration (FDA) and The Joint Commission (TJC) standards/regulations.

Responsibilities

• Oversee the review and finalization of the BMT & IMTX Quality Plan, including the development and tracking of annual Quality goals
• Plan and facilitate BMT/IMTX Quality Committee meetings (at least 4/year)
• Plan and facilitate forums to collaborate across Quality domains in service to/support of BMT/IMTX programs
• Manage BMT/IMTX Quality metric portfolio and develops plan to communicate metrics in a meaningful and actionable way, ensuring compliance with FACT requirements
• Responsible for ensuring FACT compliance with auditing standards.
• Manage/track quality improvement portfolio, ensuring all risks and QI activity are captured and status is known and communicated to relevant stakeholders
• Support implementation across BMT/IMTX Alliance partners of new and existing compliance requirements from FACT and other accreditation/regulatory bodies as needed. Help troubleshoot with Alliance partners.
• Participate in multidisciplinary teams to address quality/compliance issues.
• Support inspection preparation activities for FACT and other accreditation/regulatory bodies.
• Support the ARA department in surveys and continued survey readiness.
• May also plan or participate in various Quality activities associated with Corporate commercial or clinical trial products intended for use in BMT/IMTX.

Qualifications

Required:

• BS/BA Required (preferred in biological or healthcare field)
• 3+ years in complex/matrixed regulated environment
• 3+ years administrative or project management role
• Some familiarity with healthcare language
• Intermediate to advanced experience with Microsoft Office products: Outlook, Word, Excel, PowerPoint.
• Ability to learn other specialized programs/software packages as required.
• Excellent communication/presentation skills; expert listening, and interpersonal skills.
• Customer-focused.
• Discerning assessment and appropriate decision-making skills, including skills in priority setting and multi-tasking.
• Ability to excel in a team environment while operating with individual autonomy.
• The ability to work in an environment where regulatory interpretations are subject to change or opinion.

Preferred:

• Project Management, Lean and/or QI Certification Preferred (e.g. PMP, Six Sigma, CPHQ)
• Prior experience with healthcare accreditation
• Prior experience with quality and standards

SCCA has a mandatory COVID-19 vaccination policy, and there are no exceptions for any employee who is patient-facing and/or requires access to SCCA facilities.

Exceptions exist only for employees whose positions are fully remote, with no required access to campus. As a condition of employment, newly hired employees requiring access to campus must provide proof of vaccination before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your 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 hrops@fredhutch.org or by calling 206-667-4700.