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).