QA Document Control Manager (Operations)

Forge Biologics; Columbus (OH); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Parental leave

Job summary

Forge Biologics seeks a Manager, Document Control – QA Operations to lead the team responsible for controlled documents and records management within an active manufacturing and QA environment. You will ensure accuracy, traceability, and continuous improvement across document lifecycles.

The role requires strong leadership, eQMS (Veeva Vault) proficiency, and collaboration with manufacturing, QA, and regulatory functions to support inspections and ongoing operations.

Qualifications

• 8+ years of experience in Document Control or related GMP-regulated environment.
• Experience managing cross-functional projects and stakeholder deliverables.
• Experience using an Electronic Quality Management System (eQMS), preferably Veeva Vault.
• Strong written communication, organization, and project management skills.
• Experience leading, mentoring, or training employees.
• Ability to manage competing priorities in a fast-paced environment.
• Proficiency with Microsoft Office applications (Outlook, Teams, Word, Excel, PowerPoint).
• Ability to work flexible hours, including evenings, weekends, and holidays.

Responsibilities

• Lead the Document Control team in compliant and efficient management of controlled documents using an eQMS.
• Oversee issuance of controlled documents, batch records, labeling, forms, and logbooks to Operations and Quality departments.
• Author, review, and approve SOPs, Work Instructions, and related documents.
• Develop and monitor metrics for document change requests and cycle times.
• Collaborate with cross-functional teams to implement process improvements in document control.

Skills

Document control

Quality systems

Quality writing

Cross-functional collaboration

Project management

MS Office suite

Regulatory compliance (GMP)

Written communication

Education

Associate’s or Bachelor’s Degree

Tools

Veeva Vault

Smartsheet

Job description

Forge Biologics seeks a Manager, Document Control – QA Operations to lead the team responsible for controlled documents and records management within an active manufacturing and QA environment. You will ensure accuracy, traceability, and continuous improvement across document lifecycles.

The role requires strong leadership, eQMS (Veeva Vault) proficiency, and collaboration with manufacturing, QA, and regulatory functions to support inspections and ongoing operations.