Director, Quality Operations

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

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first-in class and best in class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND cleared FAP-targeted radiotherapy; and IM-1617, an IND cleared solid tumor ADC. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets.

Position Overview

The Director, Quality Operations will report to the Senior Director, Quality Assurance and provide strategic operational leadership and oversight across assigned programs related to clinical and commercial. This role will lead day‑to‑day activities around commercialization of Varegacestat and continuing Varegacestat clinical programs. Additional projects will eventually be added. They will work cross‑functionally and with internal and external partners to ensure product quality throughout the development lifecycle and provide strategic quality leadership aligned with company objectives. Experience with small molecules and biologics is required.

Responsibilities

Quality Operations

• Oversee quality aspects of starting material, intermediates, drug substance and drug product manufacturing as well as packaging/labeling activities.
• Review and approve specifications affecting product quality and oversee the development of master batch records, process and method validation/protocol reports and other technical documents created to support all stages of the product lifecycle, from development to commercialization.
• Disposition clinical and commercial batches.
• Ensure effective CAPA management, change controls, deviations, and other GMP related processes are followed during manufacturing and testing of products.
• Interact with manufacturing, clinical, or other functional areas that impact quality operations and provide support as needed.
• Perform risk assessments and implement appropriate quality and process controls to ensure proper oversight of production activities.
• Support vendor qualification program and monitor vendor performance.
• Prompt communication to management of potential compliance issues.
• Participate in internal and external project team meetings.

Documentation and Record Control

• Perform periodic reviews and revisions of SOPs, policies, and Quality Agreements to align with regulatory updates and business needs.
• Establish, review and/or approve Quality Agreements and ensure they properly stored and managed.
• Manage other internal and external documentation related to QA operations.

Regulatory Compliance and Inspection Readiness

• Ensure external parties are inspection ready, in compliance with regulatory requirements, and prepared for GMP audits or inspections from FDA or other international regulatory bodies.
• Collaborate with regulatory affairs and cross functional teams to support regulatory submissions, including providing necessary documentation and ensuring compliance with filing requirements.
• Support site preparation for regulatory inspections including personnel preparation and training.
• Participate in Quality Management Review meetings, as needed.
• Assist in updating CMC sections of regulatory and quality documents.

Operational Leadership and Continuous Improvement

• Drive continuous improvement initiatives across quality operations to enhance operational efficiency, reduce risk, and improve product quality.
• Provide strategic direction and hands on leadership for operations teams, ensuring alignment with business goals and regulatory demands.
• Develop and implement metrics to monitor and report on the performance of Operations, identifying areas for improvement and ensuring corrective actions are implemented.
• Promote a strong Quality culture within the organization. Identify compliance risks and be a part of the solution through ownership and collaboration.

Qualifications

• A minimum of 10 years of experience in Quality Assurance and GMP compliance within a pharmaceutical or biotechnology environment, or equivalent.
• Extensive experience supporting outsourced manufacturing models, including oversight of CMOs and external service providers.
• Experience working with small molecules and biologics (ideally ADCs).
• Demonstrated senior level experience leading global regulatory inspections and managing inspection outcomes.
• Significant experience supporting development stage programs through commercial operations.
• Proven experience with internal and external audits, CAPA management, and continuous improvement initiatives.
• Ability to travel up to 20% to support audits and regulatory inspections, domestic and international.

Knowledge and Skills

• Deep technical knowledge of global GMP and GDP regulations, regulatory inspection expectations, and quality system requirements across development stage and commercial operations.
• Demonstrated expertise in inspection readiness, regulatory inspections, and inspection response management, including FDA Form 483 responses, commitments, and remediation strategies.
• Strong understanding of quality systems, audit programs, CAPA management, recalls and risk based compliance approaches in outsourced manufacturing environments.
• Proven ability to lead quality governance, management quality review processes, and regulatory surveillance activities.
• Ability to assess, prioritize, and mitigate quality and compliance risks across CMOs, vendors, and internal operations.
• Strong leadership presence with the ability to effectively influence executive leadership and cross functional stakeholders.
• Excellent verbal, written, interpersonal, and communication skills, with the ability to clearly convey complex quality and compliance topics.

Washington State Pay Range

$212,149 — $239,998 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

E-Verify

Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).