Director, Head of Quality Management System CDx

Thanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications.Director, Head of Quality Management System CDxRedmond, WAFull TimeCDxExecutiveShareSystImmune 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.The Director, Head of Quality Management System (QMS)is responsible for establishing, leading, and continuously improving the Quality Management System for IHC-based Companion Diagnostics (CDx) across development, validation, manufacturing, regulatory submission, and post-market lifecycle.This role ensures full compliance with GMP requirements and US FDA 21 CFR 820 (Quality System Regulation), and alignment with ISO 13485 and ISO 14971. A critical responsibility of this role is to lead and govern the transition of IHC assays from RUO/LDT to regulated IVD CDx products, ensuring inspection readiness and regulatory success.The Director serves as the quality authority and management representative for CDx programs and is the primary interface for FDA inspections, audits, and regulatory interactions.Key ResponsibilitiesQMS Strategy & GovernanceEstablish, maintain, and continuously improve a GMP-compliant QMS supporting IHC CDx development and commercialization.Ensure full compliance with:US FDA 21 CFR 820 (QSR)GMP requirements for IVD/CDxISO 13485 (Medical Device QMS)ISO 14971 (Risk Management)Serve as Management Representative with authority to ensure QMS effectiveness and compliance.Define quality strategy aligned with business objectives, regulatory timelines, and CDx program milestones.RUO / LDT → IVD CDx Transition LeadershipLead quality oversight for assay lifecycle transition, including:RUO → LDT → regulated IVD CDxDefine and govern:Design control initiation pointsBridging strategies between development-phase assays and commercial IVD kitsTraceability between analytical validation, clinical performance, and labelingEnsure quality documentation supports:Assay locking and design freezeTransfer from development labs to manufacturingRegulatory submissions and post-approval changesDesign Control & Risk ManagementOwn and oversee design control processes for IHC CDx kits, including:Design inputs and user needsDesign outputs and specificationsDesign verification and validationDesign reviews and design transferEnsure ISO 14971 risk management is fully integrated, including:Risk management plansHazard analysis and risk control measuresResidual risk evaluation and benefit-risk justificationEnsure full traceability between risks, controls, verification, and labeling.Document Control & SOP ManagementEstablish and maintain document control systems for:SOPs, work instructions, forms, and recordsEnsure documents are inspection-ready, version-controlled, and compliant with 21 CFR 820.Drive SOP harmonization across R&D, pathology, manufacturing, and clinical operations.Supplier Quality & External OversightEstablish and oversee supplier quality management, including:Antibody and reagent suppliersIHC platform vendorsContract manufacturersCROs and central laboratoriesLead supplier qualification, audits, quality agreements, and ongoing performance monitoring.CAPA, Change Control & Continuous ImprovementLead and approve:Nonconformance managementDeviations and investigationsCorrective and Preventive Actions (CAPA)Change control activitiesMonitor quality metrics and trends to drive continuous improvement and risk reduction.FDA Inspection & Audit Readiness (Explicit Responsibility)Serve as the primary quality contact for:FDA inspectionsPre-approval inspections (PAI)ISO audits and partner auditsEnsure continuous inspection readiness, including:Training of staff on inspection conductMaintenance of inspection-ready documentationMock inspections and gap assessmentsLead inspection responses, including:483 observationsCAPA commitmentsRegulatory correspondence and follow-upCross-Functional Leadership & TrainingPartner with R&D, Pathology, Manufacturing, Regulatory Affairs, Clinical, and Program Management to embed quality-by-design.Provide quality training on:Design controlsRisk managementGMP and QSR requirementsBuild, mentor, and lead a high-performing QMS and quality teamQualificationsEducationBachelor’s degree required; Master’s or PhD preferred in Biomedical Engineering, Life Sciences, Pathology or related field10+ years of quality experience in CDx, medical devices5+ years in a senior quality leadership roleDirect hands-on experience with:FDA 21 CFR 820 implementationGMP systemsISO 13485 certificationISO 14971 risk managementExperience supporting IHC-based diagnostics or pathology workflows strongly preferredProven experience supporting FDA inspections and regulatory auditsCore CompetenciesDeep understanding of IVD/CDx regulatory pathwaysStrong leadership in design control and risk managementExcellent inspection-management and communication skillsAbility to influence across functions and senior leadershipHigh integrity, accountability, and decision-making authorityCompensation and Benefits:The expected base salary range for this position is $180,000 - $230,000 annually.

Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.While most offers typically fall within thelow to mid-pointof 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