Systimmune
Director, Head of Quality Management System (QMS) – IHC Companion Diagnostics (C
Systimmune, Redmond, Washington, United States, 98052
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 Responsibilities
QMS Strategy & Governance
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)
/database? just confirm
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 Leadership
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
hezulu? No Ensure quality documentation supports:
Assay locking and design freeze
Transfer from development labs to manufacturing
Regulatory submissions and post‑approval changes
Design Control & Risk Management
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.
Document Control & SOP Management
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.
Supplier Quality & External Oversight
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.
CAPA, Change Control & Continuous Improvement
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.
FDA Inspection & Audit Readiness (Explicit Responsibility)
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
Cross‑Functional Leadership & Training
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.
Qualifications
Education
Bachelor’s degree required; Master’s or PhD preferred in Biomedical Engineering, Life Sciences, Pathology or related field.
Experience
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
GMP systems
ISO 13485 certification
ISO 14971 risk management
Experience supporting IHC‑based diagnostics or pathology workflows strongly preferred.
Proven experience supporting FDA inspections and regulatory audits.
Core Competencies
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.
#J-18808-Ljbffr
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 Responsibilities
QMS Strategy & Governance
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)
/database? just confirm
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 Leadership
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
hezulu? No Ensure quality documentation supports:
Assay locking and design freeze
Transfer from development labs to manufacturing
Regulatory submissions and post‑approval changes
Design Control & Risk Management
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.
Document Control & SOP Management
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.
Supplier Quality & External Oversight
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.
CAPA, Change Control & Continuous Improvement
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.
FDA Inspection & Audit Readiness (Explicit Responsibility)
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
Cross‑Functional Leadership & Training
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.
Qualifications
Education
Bachelor’s degree required; Master’s or PhD preferred in Biomedical Engineering, Life Sciences, Pathology or related field.
Experience
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
GMP systems
ISO 13485 certification
ISO 14971 risk management
Experience supporting IHC‑based diagnostics or pathology workflows strongly preferred.
Proven experience supporting FDA inspections and regulatory audits.
Core Competencies
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.
#J-18808-Ljbffr