Manager, Document Control

Responsibilities:
- Author, own, and maintain SOPs, work instructions, and associated forms for Document Control, including document creation, formatting, review/approval, and archival.
- Ensure Document Control SOPs align with 21 CFR Part 11, EU Annex 11, and ICH Q10 and reflect current system capabilities.
- Support internal SMEs in authoring, formatting, and finalizing controlled documents.
- Ensure controlled documents are correctly formatted, numbered, version-controlled, and routed through the validated eQMS.
- Establish document metadata, classification, retention schedules, and archival in compliance with regulatory requirements and company policies.
- Facilitate periodic document review; support document owners through new, revision, and/or obsolescence workflows.
- Design, build, and maintain controlled document templates for cross-department use.
- Develop and deliver training materials on document management workflows (creation, review/approval, and electronic signature processes).

Qualifications:
- Minimum 8 years of Document Control experience in a regulated biotechnology, pharmaceutical, or medical device environment (or equivalent).
- Minimum Associate’s Degree.

Knowledge and Skills:
- Advanced Office 365 expertise (MS Word) and Adobe file types.
- Working knowledge of cGMP and current industry practices for regulated document/records management.
- Experience setting up/implementing/working with validated eQMS systems (e.g., TrackWise, MasterControl, Veeva, Dot Compliance, ZenQMS).

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