Immunome, Inc. · 17 hours ago
Senior Director, GMP Quality Compliance
Bothell, WA
Full-time
Onsite
Director/Executive
$259K/yr - $295K/yr
15+ years expImmunome, Inc. is a clinical-stage targeted oncology company committed to developing innovative cancer therapies. The Senior Director, GMP Quality Compliance will provide strategic leadership and oversight for GMP Quality Compliance programs, ensuring regulatory inspection readiness and managing internal and external audits.
BiopharmaBiotechnologyMedicalPharmaceutical
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
Qualification
Required
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
Company
Immunome, Inc.
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.
51-200 employees
H1B Sponsorship
Immunome, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Public CompanyTotal Funding
$998.85MKey Investors
JPEO-CBRNDU.S. Department of DefenseRobin Hood Ventures
2025-12-16Post Ipo Equity· $400M
2025-01-29Post Ipo Equity· $150M
2024-02-13Post Ipo Equity· $230M
Leadership Team
Clay Siegall
President and CEO
Purnanand D. Sarma
President & CEO
Recent News
2026-01-09
BioWorld Financial Watch
2025-12-19
thefly.com
2025-12-18
Company data provided by crunchbase