QA Document Control Manager — eQMS & Process Leader

Doist

Columbus (OH)

On-site

USD 95,000 - 125,000

Full time

10 days ago

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Benefits offered by this job

Health from day one
Health, dental and vision insurance
Paid time off
Parental leave
401(k) with company match
Onsite fitness facility
Employee discounts

Job summary

Forge Biologics is seeking a Manager, Document Control - QA Operations in Columbus, OH to lead the team responsible for controlled documents including SOPs, batch records, and forms. You will drive compliant document lifecycle management within our cGMP environment, coordinating with manufacturing, QA, and QC to ensure accuracy and traceability.

You will serve as SME for the eQMS and Veeva Vault, manage changes, and mentor staff while advancing continuous improvement across document control

Qualifications

  • 8+ years of Document Control/Quality Systems in GMP environments.
  • Experience managing cross-functional projects and stakeholder deliverables.
  • Experience using an Electronic Quality Management System (eQMS), preferably Veeva Vault.
  • Strong written communication, organization, and PM skills.
  • Experience leading, mentoring, or training employees.
  • Proficiency with Microsoft Office applications.
  • Ability to manage competing priorities in a fast-paced environment.

Responsibilities

  • Provide leadership and coaching to the Document Control team; remove roadblocks.
  • Set team goals aligned with site strategy; manage performance and growth.
  • Serve as SME for the document management system (eQMS, Veeva Vault).
  • Evaluate and manage document change controls with regulatory alignment.
  • Oversee issuance of controlled documents to Operations and Quality Control.
  • Author/review SOPs, Work Instructions, and related docs.
  • Administer eQMS stations in manufacturing areas for currency and control.
  • Develop, monitor, and report metrics on document changes and reviews.
  • Collaborate with cross-functional teams to implement process improvements.
  • Support maintenance, upgrades, validation of the document management system.
  • Provide documentation support for regulatory inspections and audits.

Skills

Document Control
Quality Systems
eQMS
Veeva Vault
Microsoft Office
Project Management
Cross-functional collaboration
Mentoring/Training

Education

Bachelor’s Degree
Associate’s Degree

Tools

Veeva Vault
eQMS
Smartsheet

Job description

Forge Biologics is seeking a Manager, Document Control - QA Operations in Columbus, OH to lead the team responsible for controlled documents including SOPs, batch records, and forms. You will drive compliant document lifecycle management within our cGMP environment, coordinating with manufacturing, QA, and QC to ensure accuracy and traceability.

You will serve as SME for the eQMS and Veeva Vault, manage changes, and mentor staff while advancing continuous improvement across document control

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