QA Document Control Manager - Lead Compliance & Docs

Forge Biologics; Columbus (OH); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Parental leave (12 weeks)

Job summary

Forge Biologics in Columbus, OH, seeks a Manager, Document Control - QA Operations to lead the document control team within our cGMP environment. You will oversee the eQMS (Veeva Vault), SOPs, change controls, and lifecycle management to ensure compliant documentation and records handling.

You will drive continuous improvement, monitor KPIs, mentor staff, and partner with Manufacturing and QA to support regulatory readiness and inspections at The Hearth facility.

Qualifications

• 8+ years of experience in Document Control, Quality Systems, Quality Writing, or a related GMP-regulated role.
• 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 and/or peers.

Responsibilities

• Provide leadership through effective communication, coaching, accountability, training, and development while removing roadblocks to support team execution.
• Establish clear team goals, priorities, ownership, and objectives aligned with site strategy while managing team member performance and growth.
• Serve as the subject matter expert for the document management system, including eQMS /Veeva Vault functionality and lifecycle processes.
• Evaluate, approve, and manage document change controls in the eQMS, ensuring regulatory alignment.
• Oversee issuance of controlled documents to Operations and Quality Control with accuracy and traceability.
• Author, review, and approve SOPs, work instructions, and related documents.
• Oversee administration of eQMS stations in manufacturing areas to ensure current procedures and references.
• Develop, monitor, and report metrics for document change requests and reviews.
• Collaborate with cross-functional teams to implement process improvements for document control efficiency and compliance.
• Support maintenance, upgrades, and validation of the document management system.
• Provide documentation support for regulatory inspections and internal audits.

Skills

Leadership

Cross-functional

Project management

MS Office

Written communication

Mentoring / training

Prioritization

Regulatory documentation

Education

Associate’s Degree

Bachelor's Degree

Tools

Veeva Vault

Job description

Forge Biologics in Columbus, OH, seeks a Manager, Document Control - QA Operations to lead the document control team within our cGMP environment. You will oversee the eQMS (Veeva Vault), SOPs, change controls, and lifecycle management to ensure compliant documentation and records handling.

You will drive continuous improvement, monitor KPIs, mentor staff, and partner with Manufacturing and QA to support regulatory readiness and inspections at The Hearth facility.