Company Overview
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 author, 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 development and delivery 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).
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).
Skills Required
- Minimum of 8 years of experience in Document Control within a regulated biotechnology, pharmaceutical, or medical device environment
- Minimum of an Associate's Degree
- Advanced expertise with Office 365 (MS Word especially) and Adobe file types
- Working knowledge of cGMP and industry practices for management of regulated documents and records
- Experience setting up, implementing, and/or working in validated eQMS systems (e.g., TrackWise, MasterControl, Veeva, Dot Compliance, ZenQMS)
What We Do
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. 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 targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.
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