Quality Assurance Manager
About The Position
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. We are seeking an experienced Quality Assurance Manager to support our Translational Science department, which includes both Clinical Pathology and Bioanalytical functions. This role is responsible for ensuring compliance with Bioanalytical Lab QA (GLP/FDA) as well as CLIA/CAP requirements and partnering closely with scientific and laboratory teams to maintain a robust quality system supporting biomarker, IHC, and bioanalytical assay activities. This is a senior individual contributor QA leadership role with no direct reports. This position is full-time onsite in Redmond, WA and will transition to our new Bothell, WA location in the fall.
Requirements
- Bachelor’s or Master’s degree in Life Sciences or related field
- 7+ years of QA experience in bioanalytical (GLP/FDA) and/or CLIA/CAP laboratory environments
- Strong knowledge of QMS processes (CAPA, deviation, change control, document control)
- Experience supporting or leading FDA inspections for bioanalytical labs
- Experience supporting laboratory audits and inspections
- Familiarity with clinical pathology, bioanalytical, biomarker, or IHC-based workflows preferred
Nice To Haves
- Experience in CDx, pathology/IHC, or bioanalytical labs
- Knowledge of GxP environments (GLP/GCP/GMP)
- Experience with LIMS and electronic QMS systems
- ASQ certification (e.g., CQA) is a plus
Responsibilities
- Maintain and improve the Quality Management System (QMS) in compliance with Bioanalytical Lab QA (GLP/FDA) and CLIA/CAP across Clinical Pathology and Bioanalytical labs
- Develop, review, and approve SOPs, protocols, and quality documentation
- Lead FDA inspection readiness and audits for bioanalytical laboratories, including preparation, hosting, and response management
- Lead internal audits and inspection readiness 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 with translational scientists to ensure quality integration across Clinical Pathology and Bioanalytical operations
- Track and report quality metrics and drive continuous improvement
- Serve as QA representative during regulatory inspections and client interactions
Benefits
- SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
