SystImmune · 1 day ago
Director, Head of Quality Management System (QMS) – IHC Companion Diagnostics (CDx) Development
Redmond, WA
Full-time
Onsite
Director/Executive
10+ years expSystImmune is seeking a Director, Head of Quality Management System (QMS) to lead the establishment and improvement of the Quality Management System for IHC-based Companion Diagnostics. This role involves ensuring compliance with regulatory standards, overseeing the transition of assays to regulated products, and serving as the primary quality authority for CDx programs.
BiopharmaBiotechnologyProfessional Services
Responsibilities
Establish, 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/CDx
ISO 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
Lead quality oversight for assay lifecycle transition, including:
RUO → LDT → regulated IVD CDx
Define and govern:
Design control initiation points
Bridging strategies between development-phase assays and commercial IVD kits
Traceability between analytical validation, clinical performance, and labeling
Ensure quality documentation supports:
Assay locking and design freeze
Transfer from development labs to manufacturing
Regulatory submissions and post-approval changes
Own and oversee design control processes for IHC CDx kits, including:
Design inputs and user needs
Design outputs and specifications
Design verification and validation
Design reviews and design transfer
Ensure ISO 14971 risk management is fully integrated, including:
Risk management plans
Hazard analysis and risk control measures
Residual risk evaluation and benefit-risk justification
Ensure full traceability between risks, controls, verification, and labeling
Establish and maintain document control systems for:
SOPs, work instructions, forms, and records
Ensure documents are inspection-ready, version-controlled, and compliant with 21 CFR 820
Drive SOP harmonization across R&D, pathology, manufacturing, and clinical operations
Establish and oversee supplier quality management, including:
Antibody and reagent suppliers
IHC platform vendors
Contract manufacturers
CROs and central laboratories
Lead supplier qualification, audits, quality agreements, and ongoing performance monitoring
Lead and approve:
Nonconformance management
Deviations and investigations
Corrective and Preventive Actions (CAPA)
Change control activities
Monitor quality metrics and trends to drive continuous improvement and risk reduction
Serve as the primary quality contact for:
FDA inspections
Pre-approval inspections (PAI)
ISO audits and partner audits
Ensure continuous inspection readiness, including:
Training of staff on inspection conduct
Maintenance of inspection-ready documentation
Mock inspections and gap assessments
Lead inspection responses, including:
483 observations
CAPA commitments
Regulatory correspondence and follow-up
Partner with R&D, Pathology, Manufacturing, Regulatory Affairs, Clinical, and Program Management to embed quality-by-design
Provide quality training on:
Design controls
Risk management
GMP and QSR requirements
Build, mentor, and lead a high-performing QMS and quality team
Qualification
Required
Bachelor's degree required
10+ years of quality experience in CDx, medical devices
5+ years in a senior quality leadership role
Direct hands-on experience with FDA 21 CFR 820 implementation
Direct hands-on experience with GMP systems
Direct hands-on experience with ISO 13485 certification
Direct hands-on experience with ISO 14971 risk management
Deep understanding of IVD/CDx regulatory pathways
Strong leadership in design control and risk management
Excellent inspection-management and communication skills
Ability to influence across functions and senior leadership
High integrity, accountability, and decision-making authority
Preferred
Master's or PhD preferred in Biomedical Engineering, Life Sciences, Pathology or related field
Experience supporting IHC-based diagnostics or pathology workflows strongly preferred
Proven experience supporting FDA inspections and regulatory audits
Company
SystImmune
SystImmune is a biotechnology company.
51-200 employees
H1B Sponsorship
SystImmune has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2023 (1)
2022 (2)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Martin S. Olivo, MD, MSc,
Chief Medical Officer
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