Description

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.

Key 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

Qualifications

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

Preferred Qualifications

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

Key Competencies

Strong understanding of bioanalytical QA and regulated lab environments
Hands-on experience with FDA inspection readiness and audit management
Ability to work cross-functionally with scientific and clinical teams
Detail-oriented with strong problem-solving and communication skills

Why Join Us

High-impact role supporting both Bioanalytical and Clinical Pathology functions within Translational Science
Opportunity to lead FDA inspection readiness and regulatory excellence
Collaborative, science-driven environment

Quality Assurance Manager

Description

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