Manager, Document Control

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).

Pay

Washington State Pay Range: $140,000 - $164,710 USD