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 …
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$120k–$160k/yr
Full-time
bachelor degree, postgraduate degree
Medical Insurance, Dental Insurance, Vision Insurance, Short Term Disability, Long Term Disability, 401(k) Plan
Posted 21d ago
Apply by Oct 15
~40 hrs/week
Responsibilities
Maintain and improve the Quality Management System for Clinical Pathology and Bioanalytical labs in compliance with GLP/FDA and CLIA/CAP standards. Lead FDA inspection readiness, internal audits, and manage CAPA, deviations, and document control systems.
Requirements
Requires a Bachelor's or Master's degree in Life Sciences with over 7 years of QA experience in bioanalytical or CLIA/CAP laboratory environments. Must have strong knowledge of QMS processes and experience leading FDA inspections for bioanalytical labs.
Full job 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
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
Compensation and Benefits: The expected base salary range for this position is $120,000 - $160,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s level qualifications, experience, and skills. While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role. SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. 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. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
Located in Redmond WA, founded in 2014, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. We are a group of highly experienced immuno-oncology scientists utilizing several technology platforms to develop world class advanced antibody-based drug therapies.
Offices: 22213 30th Drive SE, Bothell, WA 98021, US · 15318 NE 95th St, Redmond, Washington, US
Health CareBiopharmaProfessional ServicesBiotechnologyTherapeutics
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