Director, Head of Quality Management System (QMS) – IHC Companion Diagnostics (CDx) Development
SystImmune
1w ago
ExecutiveOncology
$180K - $230K/yr(estimated)
Description
<span style="font-size:10.5pt;"><span style="font-family:Arial;">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.</span></span><br><br><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><strong>The Director, Head of Quality Management System (QMS)</strong> 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.</span><br><br><span style="line-height:115%;">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. </span><span style="line-height:115%;">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.</span><br><br><strong><span style="line-height:115%;">Key Responsibilities</span></strong><br><span style="line-height:115%;"><b>QMS Strategy & Governance</b></span></span></span><ul style="margin-bottom:11px;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Establish, maintain, and continuously improve a GMP-compliant QMS supporting IHC CDx development and commercialization.</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Ensure full compliance with:</span></span></span><ul style="list-style-type:circle;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">US FDA 21 CFR 820 (QSR)</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">GMP requirements for IVD/CDx</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">ISO 13485 (Medical Device QMS)</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">ISO 14971 (Risk Management)</span></span></span></li></ul></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Serve as Management Representative with authority to ensure QMS effectiveness and compliance.</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Define quality strategy aligned with business objectives, regulatory timelines, and CDx program milestones.</span></span></span></li></ul><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><b>RUO / LDT → IVD CDx Transition Leadership</b></span></span></span><ul style="margin-bottom:11px;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Lead quality oversight for assay lifecycle transition, including:</span></span></span><ul style="list-style-type:circle;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">RUO → LDT → regulated IVD CDx</span></span></span></li></ul></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Define and govern:</span></span></span><ul style="list-style-type:circle;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Design control initiation points</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Bridging strategies between development-phase assays and commercial IVD kits</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Traceability between analytical validation, clinical performance, and labeling</span></span></span></li></ul></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Ensure quality documentation supports:</span></span></span><ul style="list-style-type:circle;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Assay locking and design freeze</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Transfer from development labs to manufacturing</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Regulatory submissions and post-approval changes</span></span></span></li></ul></li></ul><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><b>Design Control & Risk Management</b></span></span></span><ul style="margin-bottom:11px;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Own and oversee design control processes for IHC CDx kits, including:</span></span></span><ul style="list-style-type:circle;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Design inputs and user needs</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Design outputs and specifications</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Design verification and validation</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Design reviews and design transfer</span></span></span></li></ul></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Ensure ISO 14971 risk management is fully integrated, including:</span></span></span><ul style="list-style-type:circle;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Risk management plans</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Hazard analysis and risk control measures</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Residual risk evaluation and benefit-risk justification</span></span></span></li></ul></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Ensure full traceability between risks, controls, verification, and labeling.</span></span></span></li></ul><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><b>Document Control & SOP Management</b></span></span></span><ul style="margin-bottom:11px;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Establish and maintain document control systems for:</span></span></span><ul style="list-style-type:circle;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">SOPs, work instructions, forms, and records</span></span></span></li></ul></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Ensure documents are inspection-ready, version-controlled, and compliant with 21 CFR 820.</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Drive SOP harmonization across R&D, pathology, manufacturing, and clinical operations.</span></span></span></li></ul><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><b>Supplier Quality & External Oversight</b></span></span></span><ul style="margin-bottom:11px;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Establish and oversee supplier quality management, including:</span></span></span><ul style="list-style-type:circle;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Antibody and reagent suppliers</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">IHC platform vendors</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Contract manufacturers</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">CROs and central laboratories</span></span></span></li></ul></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Lead supplier qualification, audits, quality agreements, and ongoing performance monitoring.</span></span></span></li></ul><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><b>CAPA, Change Control & Continuous Improvement</b></span></span></span><ul style="margin-bottom:11px;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Lead and approve:</span></span></span><ul style="list-style-type:circle;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Nonconformance management</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Deviations and investigations</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Corrective and Preventive Actions (CAPA)</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Change control activities</span></span></span></li></ul></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Monitor quality metrics and trends to drive continuous improvement and risk reduction.</span></span></span></li></ul><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><b>FDA Inspection & Audit Readiness (Explicit Responsibility)</b></span></span></span><ul style="margin-bottom:11px;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Serve as the primary quality contact for:</span></span></span><ul style="list-style-type:circle;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">FDA inspections</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Pre-approval inspections (PAI)</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">ISO audits and partner audits</span></span></span></li></ul></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Ensure continuous inspection readiness, including:</span></span></span><ul style="list-style-type:circle;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Training of staff on inspection conduct</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Maintenance of inspection-ready documentation</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Mock inspections and gap assessments</span></span></span></li></ul></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Lead inspection responses, including:</span></span></span><ul style="list-style-type:circle;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">483 observations</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">CAPA commitments</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Regulatory correspondence and follow-up</span></span></span></li></ul></li></ul><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><b>Cross-Functional Leadership & Training</b></span></span></span><ul style="margin-bottom:11px;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Partner with R&D, Pathology, Manufacturing, Regulatory Affairs, Clinical, and Program Management to embed quality-by-design.</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Provide quality training on:</span></span></span><ul style="list-style-type:circle;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Design controls</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Risk management</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">GMP and QSR requirements</span></span></span></li></ul></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Build, mentor, and lead a high-performing QMS and quality team</span></span></span></li></ul><br><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><strong>Qualifications</strong><br><b>Education</b></span></span></span><ul style="margin-bottom:11px;"><li style="margin-bottom:11px;margin-left:8px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Bachelor’s degree required; Master’s or PhD preferred in Biomedical Engineering, Life Sciences, Pathology or related field</span></span></span></li></ul><ul style="margin-bottom:11px;"><li style="margin-left:8px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">10+ years of quality experience in CDx, medical devices</span></span></span></li><li style="margin-left:8px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">5+ years in a senior quality leadership role</span></span></span></li><li style="margin-bottom:11px;margin-left:8px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Direct hands-on experience with:</span></span></span><ul style="list-style-type:circle;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">FDA 21 CFR 820 implementation</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">GMP systems</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">ISO 13485 certification</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">ISO 14971 risk management</span></span></span></li></ul></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Experience supporting IHC-based diagnostics or pathology workflows strongly preferred</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Proven experience supporting FDA inspections and regulatory audits</span></span></span></li></ul><br><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><b>Core Competencies</b></span></span></span><ul style="margin-bottom:11px;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Deep understanding of IVD/CDx regulatory pathways</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Strong leadership in design control and risk management</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Excellent inspection-management and communication skills</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Ability to influence across functions and senior leadership</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">High integrity, accountability, and decision-making authority</span></span></span></li></ul><div style="margin-bottom:11px;"><br><span style="font-size:10.5pt;"><span style="font-family:Arial;"><span style="font-weight:bold;">Compensation and Benefits:</span></span></span><br><span style="font-size:10.5pt;"><span style="font-family:Arial;">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.</span></span><br><span style="font-size:10.5pt;"><span style="font-family:Arial;">While most offers typically fall within the <span style="font-weight:bold;">low to mid-point</span> 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.</span></span><br><span style="font-size:11pt;"><span style="font-family:Arial;"> </span></span><br><span style="font-size:8.25pt;"><span style="font-family:Arial;"><span style="font-weight:bold;">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.</span></span></span><br><span style="font-size:8.25pt;"><span style="font-family:Arial;"> </span></span><br><span style="font-size:8.25pt;"><span style="font-family:Arial;"><span style="font-weight:bold;">We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. </span></span></span><br><span style="font-size:8.25pt;"><span style="font-family:Arial;"> </span></span><br><span style="font-size:8.25pt;"><span style="font-family:Arial;"><span style="font-weight:bold;">SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.</span></span></span><br> 
SystImmune
BIOTECHNOLOGY
Novel therapeutic bi-specific, and multi-specific antibodies, antibody-drug conjugates
LocationWA - Redmond
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