Manager, Document Control (QA Operations)

About the Company

Forge Biologics turns bold ideas into life-changing gene therapies. Our mission is to enable access to these therapies and help bring them from concept to reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities to improve lives. Our team operates out of The Hearth, a 200,000-square-foot cGMP facility in Columbus, Ohio, where innovation is hands-on—whether scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects.

Forge’s culture is built on H.O.P.E.: Hardworking, Open, Purpose-driven, and Engaged. We foster an environment where ideas flow freely, every voice is valued, and every task contributes to changing lives. We invest in our people through mentorship, hands-on learning, and opportunities for career growth.

About the Role

The Manager, Document Control - QA Operations leads the Document Control team in the compliant and efficient management, issuance, and maintenance of controlled documents using an Electronic Quality Management System. This role supports manufacturing, quality assurance, quality control, and related operations, ensuring effective Document Control and Records Management processes while driving continuous improvement and cross-functional collaboration.

Responsibilities

• Provide leadership through effective communication, coaching, and development while removing roadblocks to support team execution.
• Establish clear team goals, priorities, and objectives aligned with site strategy; manage performance, accountability, and growth through regular coaching and feedback.
• Serve as the subject matter expert for the document management system, including eQMS/Veeva Vault functionality, document authoring, revision workflows, and controlled document lifecycle processes.
• Evaluate, approve, and manage document change controls in the eQMS, assessing operational impact and ensuring alignment with internal procedures and regulatory requirements.
• Oversee issuance of controlled documents (batch records, labeling, forms, logbooks) to Operations and Quality Control departments, ensuring accuracy, traceability, and compliance.
• Author, review, and approve controlled documentation, including Standard Operating Procedures (SOPs), Work Instructions, and related documents.
• Oversee administration of eQMS stations in manufacturing areas to ensure current, available, and controlled procedures, forms, and reference documents.
• Develop, monitor, and report metrics and key performance indicators for document change requests, document change controls, controlled copies, and periodic reviews.
• Collaborate with cross-functional teams, SMEs, and stakeholders to identify, lead, and implement process improvements that enhance document control efficiency, compliance, and procedural alignment.
• Support periodic maintenance, upgrades, and validation activities for the document management system, including related procedure updates.
• Provide documentation support for regulatory inspections and internal audits, ensuring documentation readiness, accessibility, and compliance.

Requirements

• 8+ years of experience in Document Control, Quality Systems, Quality Writing, or a related role within a GMP-regulated environment supporting manufacturing and/or laboratory operations.
• Experience managing cross-functional projects and stakeholder deliverables.
• Experience using an Electronic Quality Management System (eQMS), preferably Veeva Vault or a comparable document management platform.
• Strong written communication, organization, and project management skills, with the ability to present technical documentation clearly to internal and external stakeholders.
• Previous experience leading, mentoring, or training employees and/or peers.
• Ability to manage competing priorities in a fast-paced, deadline-driven environment while maintaining accuracy, completeness, and compliance.
• Proficiency with Microsoft Office applications (Outlook, Teams, Word, Excel, PowerPoint).
• Ability to work flexible hours, including evenings, weekends, and holidays to support manufacturing production schedules.

Preferred Skills

• Associate’s or Bachelor’s Degree.
• Proficiency with Project Management software (Smartsheet).
• Formal training in technical writing, instructional design, or regulatory documentation.
• Advanced skills in Microsoft Word formatting, styles, and templates.
• Familiarity with CDMO operations and client-driven project timelines.
• Strong interpersonal skills with the ability to influence and coach SMEs and stakeholders.
• Experience supporting documentation teams through regulatory inspections (e.g., FDA, EMA).

Work Environment and Physical Demands

This position works in a typical office environment with varying physical demands depending on tasks. It is largely sedentary, with lighting, temperature, and noise typical of an open floor-plan office. Regularly operates a computer and other office equipment, communicates in person, over the phone, and electronically, and may move or carry objects weighing up to 10 lbs.

Benefits

• Health from day one: Health, dental, and vision insurance starting your first day, with 90% of premiums covered for you and your family.
• Time to recharge: Competitive paid time off plan and 12 weeks of fully paid parental leave.
• Rewarding your impact: Annual bonus opportunities for all full-time team members and a 401(k) with company match.
• Special employee discounts: Including childcare and dependent care savings.
• Your wellness, supported: Onsite fitness facility, mental health counseling, financial planning services, and employer-paid short and long-term disability coverage.
• Fuel for your workday: A fully stocked kitchen with free snacks and beverages.
• Grow with us: Ongoing professional development resources, training, and mentorship programs.