Senior Document Control Manager – Regulatory QMS Expert

Immunomeinc; Bothell (WA); On-site; USD 140,000 - 164,710; Full time

Job summary

Immunomeinc in Bothell, Washington is seeking a Manager, Document Control to lead the Document Control Program within the Quality Assurance team. This role is essential for ensuring that controlled documents comply with regulations and internal standards.

The ideal candidate will have over 8 years of experience in Document Control in a regulated environment and will be responsible for document management processes, SOP authoring, and training colleagues across departments.

A competitive salary range of $140,000 — $164,710 USD is offered, reflecting the importance of this role in maintaining high-quality standards.

Qualifications

• 8+ years of experience in Document Control in a regulated environment.
• In-depth understanding of document management processes.

Responsibilities

• Author and maintain SOPs and work instructions for Document Control.
• Ensure Document Control SOPs align with regulatory frameworks.
• Support document authors with formatting and finalization.
• Manage controlled documents through the validated eQMS.
• Establish metadata and archival processes in compliance with regulations.
• Facilitate periodic document reviews and workflows.
• Maintain controlled document templates for departments.
• Deliver engaging training materials on document management workflows.

Skills

Advanced expertise with Office 365

Working knowledge of cGMP

Previous experience with validated eQMS systems

Education

Associate's Degree

Job description

Immunomeinc in Bothell, Washington is seeking a Manager, Document Control to lead the Document Control Program within the Quality Assurance team. This role is essential for ensuring that controlled documents comply with regulations and internal standards.

The ideal candidate will have over 8 years of experience in Document Control in a regulated environment and will be responsible for document management processes, SOP authoring, and training colleagues across departments.

A competitive salary range of $140,000 — $164,710 USD is offered, reflecting the importance of this role in maintaining high-quality standards.