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Forge Biologics is seeking a Manager of Document Control for QA Operations to lead the Document Control team at their state-of-the-art 200,000-square-foot cGMP manufacturing facility in Columbus, Ohio. The facility specializes in AAV (adeno-associated virus) manufacturing for gene therapy applications.
In this role, you will oversee the compliant and efficient management, issuance, and maintenance of controlled documents using an Electronic Quality Management System (EQMS). You'll support manufacturing, quality assurance, quality control, and related operations while ensuring effective document control and records management processes.
Key responsibilities include:
- Provide leadership to the Document Control team through effective communication, coaching, training, and development
- Establish clear team goals, priorities, ownership, and objectives aligned with site strategy
- Manage team member performance, development, accountability, and growth through regular coaching and feedback
- Ensure compliant document management processes that support regulatory requirements (FDA, cGMP)
- Drive continuous improvement initiatives and cross-functional collaboration
- Remove roadblocks to support team execution
- Oversee records management and EQMS administration
You'll be part of Forge Biologics' mission to enable access to life-changing gene therapies. The company culture emphasizes H.O.P.E.: hardworking, open, purpose-driven, and engaged. The role offers opportunities for professional growth through mentorship and hands-on learning in a fast-paced biotech manufacturing environment.
The position is based at The Hearth facility in Columbus, Ohio, where you'll work alongside scientists, engineers, and quality professionals dedicated to advancing gene therapy manufacturing.
