Director, Head of Quality Management System CDx

Director, Head Of Quality Management System (QMS)

Syst Immune 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). Syst Immune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, Syst Immune 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.

• QMS Strategy & Governance
• RUO / LDT → IVD CDx Transition Leadership
• Design Control & Risk Management
• Document Control & SOP Management
• Supplier Quality & External Oversight
• CAPA, Change Control & Continuous Improvement
• FDA Inspection & Audit Readiness (Explicit Responsibility)
• Cross-Functional Leadership & Training

• 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

• 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.

Syst Immune 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. Syst Immune 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.

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