Immunome, Inc. · 5 hours ago
Senior Manager/Associate Director, Quality Systems
Bothell, Washington, United States
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$175K/yr - $191K/yr
5+ years expImmunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. The Sr. Manager/Assoc Director, Quality Systems supports the development and maintenance of the Quality Management System to ensure compliance with regulatory requirements and internal quality standards, while driving continuous improvement and inspection readiness.
BiopharmaBiotechnologyMedicalPharmaceutical
Responsibilities
Support internal personnel in the understanding and execution of procedures related to initiating and managing deviations and CAPAs using the eQMS
Act as subject matter expert on the eQMS workflows that govern deviations, investigations and CAPA
Monitor status of open quality records in the eQMS as needed to facilitate on time completion with functional areas
Lead and/or support causal analysis exercises as needed
In partnership with Quality Systems Head, create and distribute metrics, analytics and performance indicators for the Quality Management System
As assigned, coordinate and administer change control processes for GMP and quality-related changes
Provide support as needed to functional areas SMEs to initiate and manage change controls in the eQMS
Monitor change control status and lifecycle metrics and work closely with internal teams to ensure timely approvals and closures
Support the development and ongoing improvement of associated procedures for handling of product complaints
Partner cross-functionally with clinical and commercial SMEs to ensure robust process
Act as primary contact within Quality for the product complaint handling processes, including investigation, and documentation as needed
Collaborate with cross-functional teams to ensure comprehensive assessment of product impact and determination of appropriate actions
Trend and report complaint data to identify quality signals and potential improvements
Support Quality Risk Management activities in alignment with ICH Q9 principles
When necessary, facilitate and/or support risk assessments (e.g., FMEA, risk matrices) related to processes, changes, deviations, and complaints
Ensure risks are appropriately documented, mitigated, and reviewed in the Quality System
Support the day-to-day operations related to document control and GxP Document and Records management
Create/own SOPs and work instructions related to document/records management when assigned
Create and manage document templates for use with the EDMS/eQMS as assigned
Drive continual improvement and support ongoing implementation and configuration of eDMS in alignment with Immunome business requirements
Develop and deliver training to personnel on how to navigate the document management system as well as author, review and/or approve documents in the eDMS
Provide SME support for audits and inspections such as providing documents, records and data from the eQMS upon request
Plan and implement system configuration changes that will enable continuous improvement to the document development and management process
Act as supporting contact and SME for GxP Training Program Administration
Support the creation and/or update to GxP Training Curriculum in eDMS/eQMS
Provide training completion reports in support of QMR or other reporting needs
When assigned, generate and analyze quality metrics and trending reports for management review
Support the identification of process inefficiencies and contribute to continuous improvement initiatives
Support quality culture initiatives and promote adherence to quality principles across the organization
Qualification
Required
Bachelor's degree in life sciences
5+ years (Sr. Manager) or 8+ years (Assoc. Director) relevant QS experience in a regulated biotechnology, pharmaceutical company
Hands-on experience with deviations, change control, CAPA, quality risk management, and product complaints
Excellent proficiency in Microsoft Applications, especially MS Word
Demonstrated experience working with data and ability to prepare and present in an effective visual format. Use of tools such as excel and/or smartsheet highly desired
Strong understanding of GMP regulations and quality systems
Demonstrated proficiency with Microsoft Office (Word, Excel, PowerPoint) applications. Super user with MS Word features/functions and how that translates to document control systems
Proficiency with electronic QMS (eQMS) systems (e.g., MasterControl, TrackWise, Veeva, Dot Compliance), including set up / implementation experience
Excellent investigation and root cause analysis skills
Strong written and verbal communication skills
Detail-oriented with strong organizational and time-management abilities
Ability to work collaboratively with cross-functional teams
Analytical mindset with the ability to interpret quality data and trends
Excellent knowledge of data integrity principles and how to apply in the management of EDMS/eQMS
Continual improvement mindset with a proactive approach to problem-solving and process improvement
Experience supporting clinical and commercial stage programs, with a strong understanding of the product lifecycle from development through to commercialization
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