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)
• 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
• 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