Quality Operations Leader – Clinical & Commercial

Immunome, Inc.; Bothell (WA); On-site; USD 212,149 - 239,998; Full time

Job summary

Immunome, Inc. in Bothell, WA seeks a Director of Quality Operations to provide strategic, hands-on leadership across clinical and commercial programs, ensuring product quality from development through commercialization.

The role covers manufacturing quality, documentation, regulatory readiness, CAPA and change controls, vendor oversight, and inspection readiness, with up to 20% travel to support audits. We value deep GMP knowledge and experience with CMOs, small molecules, and biologics,

Qualifications

• 10+ years of QA and GMP compliance experience in pharma/biotech.
• Experience overseeing CMOs and external providers.
• Experience with small molecules and biologics, ADCs preferred.
• Senior-level experience leading regulatory inspections.
• Experience supporting development-stage programs through commercial operations.
• Audits, CAPA management, and continuous improvement experience.
• Willingness to travel up to 20% domestically and internationally.

Responsibilities

• Oversee quality aspects of starting material to drug product manufacturing and packaging.
• Review specifications and master batch records; support validation.
• Disposition clinical and commercial batches.
• Ensure CAPA, change controls, deviations, and GMP processes are followed.
• Interact with cross-functional areas to support quality operations.
• Perform risk assessments and implement controls.
• Communicate potential compliance issues to management.
• Participate in project team meetings.

Skills

GMP compliance

Regulatory inspections

Quality systems

CAPA management

Leadership

Audit programs

Vendor management

Risk management

Job description

Immunome, Inc. in Bothell, WA seeks a Director of Quality Operations to provide strategic, hands-on leadership across clinical and commercial programs, ensuring product quality from development through commercialization.

The role covers manufacturing quality, documentation, regulatory readiness, CAPA and change controls, vendor oversight, and inspection readiness, with up to 20% travel to support audits. We value deep GMP knowledge and experience with CMOs, small molecules, and biologics,