Director, Quality Operations
Immunome, Inc.
August 07, 2026
On-site
Bothell, WA
Operations
Position Overview
- Director, Quality Operations reporting to the Senior Director, Quality Assurance; provide strategic operational leadership and oversight across assigned clinical and commercial programs. Lead day-to-day activities for Varegacestat commercialization and ongoing Varegacestat clinical programs. Ensure product quality across the development lifecycle through cross-functional and partner collaboration. Experience with small molecules and biologics required.
Responsibilities
- Oversee quality aspects of starting material, intermediates, drug substance and drug product manufacturing, and packaging/labeling.
- Review/approve specifications affecting product quality; oversee master batch records and process/method validation/protocol reports and other technical documents from development through commercialization.
- Disposition clinical and commercial batches.
- Ensure CAPA management, change controls, deviations, and other GMP processes are followed.
- Partner with manufacturing/clinical/other teams impacting quality operations.
- Perform risk assessments; implement quality and process controls.
- Support vendor qualification; monitor vendor performance.
- Communicate potential compliance issues to management.
- Participate in internal and external project team meetings.
- Periodically review/revise SOPs, policies, and Quality Agreements.
- Establish/review/approve and manage Quality Agreements.
- Ensure external parties are inspection-ready for GMP audits/inspections (FDA/international).
- Support regulatory submissions with required documentation; support inspection site preparation, training, QMR meetings, and CMC updates.
- Drive continuous improvement; provide strategic direction and hands-on leadership; develop metrics and implement corrective actions.
- Promote a strong Quality culture and address compliance risks through ownership/collaboration.
Qualifications
- 10+ years in Quality Assurance and GMP compliance in pharma/biotech.
- Extensive outsourced manufacturing oversight (CMOs/external providers).
- Experience with small molecules and biologics (ideally ADCs).
- Senior-level leadership of global regulatory inspections and inspection outcome management.
- Experience supporting development-stage programs through commercial operations.
- Proven internal/external audit, CAPA, and continuous improvement experience.
- Ability to travel up to 20% for audits/inspections.
- Director, Quality Operations reporting to the Senior Director, Quality Assurance; provide strategic operational leadership and oversight across assigned clinical and commercial programs. Lead day-to-day activities for Varegacestat commercialization and ongoing Varegacestat clinical programs. Ensure product quality across the development lifecycle through cross-functional and partner collaboration. Experience with small molecules and biologics required.
Responsibilities
- Oversee quality aspects of starting material, intermediates, drug substance and drug product manufacturing, and packaging/labeling.
- Review/approve specifications affecting product quality; oversee master batch records and process/method validation/protocol reports and other technical documents from development through commercialization.
- Disposition clinical and commercial batches.
- Ensure CAPA management, change controls, deviations, and other GMP processes are followed.
- Partner with manufacturing/clinical/other teams impacting quality operations.
- Perform risk assessments; implement quality and process controls.
- Support vendor qualification; monitor vendor performance.
- Communicate potential compliance issues to management.
- Participate in internal and external project team meetings.
- Periodically review/revise SOPs, policies, and Quality Agreements.
- Establish/review/approve and manage Quality Agreements.
- Ensure external parties are inspection-ready for GMP audits/inspections (FDA/international).
- Support regulatory submissions with required documentation; support inspection site preparation, training, QMR meetings, and CMC updates.
- Drive continuous improvement; provide strategic direction and hands-on leadership; develop metrics and implement corrective actions.
- Promote a strong Quality culture and address compliance risks through ownership/collaboration.
Qualifications
- 10+ years in Quality Assurance and GMP compliance in pharma/biotech.
- Extensive outsourced manufacturing oversight (CMOs/external providers).
- Experience with small molecules and biologics (ideally ADCs).
- Senior-level leadership of global regulatory inspections and inspection outcome management.
- Experience supporting development-stage programs through commercial operations.
- Proven internal/external audit, CAPA, and continuous improvement experience.
- Ability to travel up to 20% for audits/inspections.