Quality Assurance Manager

Overview

Syst Immune 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). Syst Immune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, Syst Immune has a robust preclinical pipeline of potential cancer therapeutics in the discovery 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.

• 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

• 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

• 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

• 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

• 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

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.

Syst Immune 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. Syst Immune 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 are an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.