Senior Director, GMP Quality Compliance

Immunome, Inc.•Bothell, WA

4h•$259,316 - $295,487

About The Position

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, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets. The Senior Director, GMP Quality Compliance will report to the Senior Vice President, Quality and will provide strategic leadership, oversight, and continuous improvement of Immunome’s GMP Quality Compliance programs. This role is accountable for regulatory inspection readiness and management, internal and external audit oversight, management of recalls, regulatory surveillance, quality culture and continuous improvement initiatives across development-stage and commercial operations.

Requirements

Bachelor’s degree in a scientific discipline required; advanced degree preferred.
A minimum of 15 years of experience in Quality Assurance and GMP compliance within a pharmaceutical or biotechnology environment.
Extensive experience supporting outsourced manufacturing models, including oversight of CMOs and external service providers.
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.
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.

Responsibilities

Provide strategic leadership and oversight for regulatory inspection readiness and management, including FDA, EMA, PMDA, and other health authorities.
Lead regulatory inspections, including preparation, execution, and post-inspection response activities, ensuring sustained inspection readiness across the organization.
Oversee the development, review, and approval of regulatory inspection responses, including FDA Form 483 responses, commitments, and remediation plans.
Provide governance and oversight of internal and external audit programs across GMP and GDP operations.
Oversee audits of CMOs, vendors, service providers, and internal operations, ensuring timely issue resolution and CAPA effectiveness.
Ensure quality systems, policies, and compliance frameworks remain aligned with evolving global regulatory requirements and industry best practices.
Lead management of recalls and related executive-level quality governance forums.
Provide oversight of regulatory intelligence and surveillance activities and translate regulatory changes into actionable quality strategies.
Partner with Technical Operations, Regulatory Affairs, Clinical, Supply Chain, and other functions to ensure effective GMP and GDP compliance oversight.
Support vendor selection, qualification, quality agreements, and ongoing vendor oversight, including remediation of audit-related findings.
Promote a strong Quality culture and lead continuous improvement initiatives across inspection readiness, audit effectiveness, and compliance performance.