Quality Assurance Manager

Quality Assurance ManagerSystImmune 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 ResponsibilitiesMaintain and improve the Quality Management System (QMS) in compliance with Bioanalytical Lab QA (GLP/FDA) and CLIA/CAP across Clinical Pathology and Bioanalytical labsDevelop, review, and approve SOPs, protocols, and quality documentationLead FDA inspection readiness and audits for bioanalytical laboratories, including preparation, hosting, and response managementLead internal audits and inspection readiness for CLIA/CAP and external auditsManage CAPA, deviations, change control, and document control systemsEnsure training compliance and documentation across both functional areasSupport assay validation, method transfer, and fit-for-purpose biomarker and bioanalytical workflowsPartner with translational scientists to ensure quality integration across Clinical Pathology and Bioanalytical operationsTrack and report quality metrics and drive continuous improvementServe as QA representative during regulatory inspections and client interactionsQualificationsBachelor's or Master's degree in Life Sciences or related field7+ years of QA experience in bioanalytical (GLP/FDA) and/or CLIA/CAP laboratory environmentsStrong knowledge of QMS processes (CAPA, deviation, change control, document control)Experience supporting or leading FDA inspections for bioanalytical labsExperience supporting laboratory audits and inspectionsFamiliarity with clinical pathology, bioanalytical, biomarker, or IHC-based workflows preferredPreferred QualificationsExperience in CDx, pathology/IHC, or bioanalytical labsKnowledge of GxP environments (GLP/GCP/GMP)Experience with LIMS and electronic QMS systemsASQ certification (e.g., CQA) is a plusKey CompetenciesStrong understanding of bioanalytical QA and regulated lab environmentsHands-on experience with FDA inspection readiness and audit managementAbility to work cross-functionally with scientific and clinical teamsDetail-oriented with strong problem-solving and communication skillsWhy Join UsHigh-impact role supporting both Bioanalytical and Clinical Pathology functions within Translational ScienceOpportunity to lead FDA inspection readiness and regulatory excellenceCollaborative, science-driven environmentCompensation 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. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.