Senior Director, Development QA & Regulatory Readiness

Immunome, Inc.; Bothell (WA); On-site; USD 260,000 - 294,000; Full time

Job summary

Immunome, Inc. in Bothell, WA is seeking a Senior Director, Development Quality Assurance to lead global quality strategies across GCP, GLP, GVP programs supporting clinical development.

You will build a mature QMS, oversee audits, and drive inspection readiness with cross-functional teams. As a senior leader, you will partner with Clinical Development, Regulatory Affairs, Pharmacovigilance and CROs to ensure risk-based compliance, implement AI-enabled quality improvements, and mentor QA

Qualifications

• 15+ years in biotech/pharma quality assurance or GxP environments.
• 5+ years leading quality professionals and quality systems.
• Experience building or improving Quality Management Systems.
• Experience with global clinical development programs and inspections.

Responsibilities

• Lead risk-based audit programs across clinical programs, vendors, and associated activities.
• Partner with stakeholders to identify quality risks and establish audit priorities.
• Lead or oversee internal and external audits of clinical sites, CROs, labs, vendors, and quality systems.
• Review audit findings, support root cause analyses, and ensure CAPAs are effective.
• Coordinate regulatory inspection readiness activities and support inspections.
• Develop and maintain quality metrics, dashboards, and risk indicators.

Skills

Leadership

Quality Assurance

Cross-functional

Risk Management

Communication

Analytics

AI/ML knowledge

Education

Bachelor's or Master's in Life Sciences

Tools

TrackWise

MasterControl

Veeva Quality

Job description

Immunome, Inc. in Bothell, WA is seeking a Senior Director, Development Quality Assurance to lead global quality strategies across GCP, GLP, GVP programs supporting clinical development.

You will build a mature QMS, oversee audits, and drive inspection readiness with cross-functional teams. As a senior leader, you will partner with Clinical Development, Regulatory Affairs, Pharmacovigilance and CROs to ensure risk-based compliance, implement AI-enabled quality improvements, and mentor QA