Director, Head of Quality Management System CDx

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.

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

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

Compensation 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 the low to mid-point 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.

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 is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.