Immunome, Inc. · 8 hours ago
Associate Director of Quality Operations
Bothell, Washington, United States
Full-time
Onsite
Lead/Staff, Director/Executive
$175K/yr - $202K/yr
9+ years expImmunome is a clinical-stage targeted oncology company committed to developing innovative cancer therapies. The Associate Director of Quality Operations will provide strategic and operational QA leadership across clinical and commercial manufacturing operations, ensuring compliance with regulatory standards and driving continuous improvement initiatives.
BiopharmaBiotechnologyMedicalPharmaceutical
Responsibilities
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 early phase through 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
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 are properly stored and managed
Manage other internal and external documentation related to QA operations
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
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
Qualification
Required
Bachelor's degree in life sciences, chemistry, engineering, or related field; advanced degree (MS, PhD, MBA) preferred
A minimum of 9 years of experience in pharmaceutical, biotechnology, or life sciences industries industry quality assurance
Quality operations and ADC experience is a requirement
Proven experience in managing GMP operations, QMS, including vendor management and CMO oversight
Strong knowledge of FDA, EMA, ICH, and other global regulatory guidelines and their application to Quality Operations
Experience supporting clinical and commercial stage programs, with a strong understanding of the product lifecycle from development through to commercialization
Position may require domestic and international travel (up to 20%)
Strong project management, organizational, and leadership skills with the ability to multitask and prioritize in a fast-paced environment
Excellent verbal and written communication skills, with the ability to collaborate effectively across functions and at all levels of the organization
Demonstrated ability to lead cross-functional teams and manage external vendors and stakeholders
Proficiency in using electronic QMS platforms (e.g., MasterControl, TrackWise, Dot Compliance) and Microsoft Office (Word, Excel, PowerPoint)
Strategic thinking with a proactive approach to problem-solving and process improvement
Strong experienced with antibody drug conjugates and biologics manufacturing processes
Preferred
Advanced degree (MS, PhD, MBA)
Some experience with small molecule manufacturing processes, a plus
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
Company data provided by crunchbase