Manager, Document Control

Responsibilities

• Author, own, and maintain SOPs, work instructions, and associated forms governing the Document Control process
• Ensure Document Control SOPs align with regulatory frameworks including 21 CFR Part 11, EU Annex 11, and ICH Q10
• Support internal SMEs in authoring, formatting, and finalizing controlled documents
• Ensure all controlled documents are correctly formatted, numbered, version-controlled, and routed through the validated eQMS
• Manage document metadata, classification, retention schedules, and archival in compliance with regulations
• Facilitate periodic document review and support workflows for new, revision, and obsolescence processes
• Design and maintain controlled document templates to ensure visual consistency and compliance
• Develop and deliver training materials such as quick reference guides and video tutorials on document management workflows

Requirements

• Minimum of 8 years of experience in Document Control within biotechnology, pharmaceutical, or medical device environments
• Minimum of an Associate's Degree
• Advanced expertise with Office 365 (specifically MS Word) and Adobe file types
• Working knowledge of cGMP and industry standards for regulated documents and records
• Experience setting up, implementing, or working in validated eQMS systems (e.g., TrackWise, MasterControl, Veeva, Dot Compliance, ZenQMS)

About the Company

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies, including antibody-drug conjugates.