Quality Assurance Manager

We are seeking an experienced Quality Assurance Manager to join a growing translational science organization within a well-funded clinical-stage biotechnology company focused on innovative oncology therapeutics.

Location: Redmond, WA (onsite; transitioning to Bothell, WA in the fall)

Type: Full Time

Compensation: Base salary $120,000–$160,000 (DOE)

Industry: Biotechnology

• Maintain and improve the Quality Management System (QMS) across Clinical Pathology and Bioanalytical labs in compliance with Bioanalytical Lab QA (GLP/FDA) and CLIA/CAP requirements
• Develop, review, and approve SOPs, protocols, and other quality documentation
• Lead FDA inspection readiness and support bioanalytical lab audits, including preparation, hosting, and response management
• Lead internal audits and inspection readiness activities for CLIA/CAP and external audits
• Manage CAPA, deviations, change control, and document control systems
• Ensure training compliance and documentation across both functional areas
• Support assay validation, method transfer, and fit-for-purpose biomarker and bioanalytical workflows
• Partner closely with translational scientists to integrate quality across Clinical Pathology and Bioanalytical operations
• Track and report quality metrics and drive continuous improvement initiatives
• Serve as QA representative during regulatory inspections and client interactions

• Bachelor’s or Master’s degree in Life Sciences or a related field
• 7+ years of QA experience in bioanalytical (GLP/FDA) and/or CLIA/CAP laboratory environments
• Strong knowledge of QMS processes, including CAPA, deviations, change control, and document control
• Experience supporting or leading FDA inspections for bioanalytical labs
• Experience supporting laboratory audits and inspections
• Ability to work cross-functionally with scientific and clinical teams
• Strong problem-solving, communication, and organizational skills
• Comfortable in a hands-on senior individual contributor role with no direct reports

• Experience in CDx, pathology/IHC, or bioanalytical lab settings
• Knowledge of GxP environments, including GLP, GCP, and GMP
• Experience with LIMS and electronic QMS systems
• ASQ certification such as CQA

• Collaborative, science-driven team environment
• High-visibility role supporting both Bioanalytical and Clinical Pathology within Translational Science
• Opportunity to lead inspection readiness and strengthen regulatory excellence
• Standard onsite work environment with close partnership across laboratory and scientific teams

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• Met Life Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note:

Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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