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 Manager, Document Control will support the head of Quality Systems to define and implement the corporate requirements for the regulated Document Control Program. This role serves as a critical member of the Quality Assurance team, responsible for the administration, maintenance, and continuous improvement of the Document and Records management process within the electronic Quality Management System (eQMS). This role ensures that all controlled documents and electronic records comply with applicable regulations and internal standards, including, but not limited to 21 CFR Parts 11, and Parts 210/211. The Document Controller serves as both a subject matter expert and a hands-on practitioner, owning end-to-end document lifecycle management activities while also training and mentoring colleagues on system use and internal requirements.
Responsibilities
- Author, own, and maintain SOPs, work instructions, and associated forms that govern the Document Control process, including document creation, formatting, review/approval, and archival.
- Ensure Document Control SOPs are aligned with applicable regulatory frameworks (21 CFR Part 11, EU Annex 11, ICH Q10) and reflect current system capabilities.
- Support internal SMEs as they a uthor, format, and finalize controlled documents.
- Ensure all controlled documents are correctly formatted , numbered, version-controlled, and routed through the validated eQMS .
- Ensure that document metadata, classification, retention schedules, and archival are established in compliance with regulatory requirements and company policies.
- Facilitate periodic document review and support document owners through new, revision, and/or obsolescence workflows .
- Design, build, and maintain controlled document templates for use across departments, ensuring visual consistency and compliance to internal procedures .
- Collaborate in the d evelop ment and deliver y of engaging training materials (quick reference guides, job aids, video tutorials, classroom sessions) on document management workflows including document creation, review, approval, and electronic signature processes.
Qualifications
- A minimum of 8 years of experience in Document Control within a regulated biotechnology, pharmaceutical, or medical device environment, or equivalent.
- A minimum of an Associate's Degree.
Knowledge and Skills
- Advanced expertise with Office 365 (MS Word especially) and Adobe file types .
- Working knowledge of cGMP and current industry practices and standards for management of regulated documents and records .
- Previous experience setting up, implementing and/or working in validated eQMS systems ( e.g. TrackWise , MasterControl , Veeva, Dot Compliance, ZenQMS , etc) .
Washington State Pay Range
$140,000 — $164,710 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) .