Global Quality Operations Director for Biotech & ADCs

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

Job summary

Immunome, Inc. in Washington state seeks a Director of Quality Operations to lead strategic quality oversight across clinical and commercial programs, with emphasis on Varegacestat-related operations.

The role requires expertise in GMP, small molecules and biologics, and coordination with cross-functional teams to ensure product quality throughout development and commercialization. The ideal candidate will manage QA activities from starting materials through finished drug product, drive CAPA and

Qualifications

• 10+ years in QA and GMP in pharma/biotech.
• Experience with outsourced CMOs and external providers.
• Experience with small molecules and biologics (ADCs preferred).
• Leadership in global regulatory inspections and outcomes.
• Audits, CAPA, and continuous improvement expertise.
• Willingness to travel up to 20% domestically and internationally.

Responsibilities

• Oversee quality aspects of starting material to drug product manufacturing and packaging.
• Review/approve specifications and master batch records; validate reports.
• Disposition clinical and commercial batches.
• Ensure CAPA, change controls, deviations follow GMP.
• Interact with manufacturing, clinical, and other areas; provide QA support.
• Perform risk assessments and implement quality controls.
• Support vendor qualification and monitor performance.
• Communicate potential compliance issues to management.
• Participate in internal/external project team meetings.
• Establish Quality Agreements and manage QA documentation.
• Prepare for regulatory inspections; support regulatory submissions.
• Maintain inspection readiness and quality governance.

Skills

GMP compliance

Regulatory inspections

Quality systems

Vendor management

Audit programs

CAPA management

Leadership

Global programs

Job description

Immunome, Inc. in Washington state seeks a Director of Quality Operations to lead strategic quality oversight across clinical and commercial programs, with emphasis on Varegacestat-related operations.

The role requires expertise in GMP, small molecules and biologics, and coordination with cross-functional teams to ensure product quality throughout development and commercialization. The ideal candidate will manage QA activities from starting materials through finished drug product, drive CAPA and