Quality Assurance Manager

SystImmune; Redmond (WA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

100% paid employee premiums (medical/d

401(k) company match up to 3%

15 PTO days per year

Sick leave

11 paid holidays

Job summary

SystImmune is seeking an experienced Quality Assurance Manager to support Translational Science, including Clinical Pathology and Bioanalytical functions. This senior role ensures QA compliance with GLP/FDA standards as well as CLIA/CAP, partnering with scientists to maintain a robust quality system for biomarker, IHC, and assay activities.

The role is full-time onsite in Redmond, WA, with a planned move to Bothell, WA in the fall.

Qualifications

• 7+ years of QA experience in GLP/FDA bioanalytical and/or CLIA/CAP labs.
• Strong knowledge of CAPA, deviation, change control, and document control.
• Experience supporting FDA inspections for bioanalytical labs.
• Familiarity with clinical pathology, bioanalytical, biomarker, or IHC workflows preferred.

Responsibilities

• Maintain and improve the QMS in Bioanalytical Lab QA and CLIA/CAP.
• Develop, review, and approve SOPs, protocols, and quality documentation.
• Lead FDA inspection readiness and audits for bioanalytical labs.
• 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 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.

Skills

QA experience

FDA inspections

Lab audits

QMS processes

Cross-functional collaboration

Education

Bachelor's or Master’s in Life Sciences

Tools

LIMS

Electronic QMS

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
• 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

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.

Equal Opportunity

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.