Forge Your Future with Us:
At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you're driven by purpose and excited to make a tangible impact, this is where your journey begins.
Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won't just watch innovation happen — you'll be part of it. Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases.
What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely, and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together.
At Forge, your growth matters. We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we're proud to see team members grow with us.
If you're ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself.
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 utilizing an Electronic Quality Management System. Supporting manufacturing, quality assurance, quality control, and related operations, this role ensures effective Document Control and Records Management processes while driving continuous improvement and cross-functional collaboration.
Responsibilities:
- Provide leadership through effective communication, consistent coaching, reinforcing 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, development, 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 applicable regulatory requirements.
- Oversee issuance of controlled documents, including batch records, labeling, forms, and logbooks, to Operations and Quality Control departments while 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 required procedures, forms, and reference documents are current, available, and controlled.
- Develop, monitor, and report metrics and key performance indicators for document change requests, document change controls, controlled copies, and periodic reviews to support timely stakeholder evaluation and document effectiveness.
- 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.
Qualifications:
- 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, including Outlook, Teams, Word, Excel, and 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).
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned.
Work Environment and Physical Demands
This position works in a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. This is largely a sedentary role; persons holding office positions are generally subject to inside environmental conditions having the lighting, temperature, and noise of an open floor-plan office environment. Regularly operate a computer and other office equipment. Regularly communicate with others in person, over the phone, and electronically. Must be able to move and/or carry objects weighing up to 10 lbs.
Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
We've Got You Covered:
At Forge Biologics, we believe our people deserve to be taken care of – in and out of the workplace. We've built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:
Health from day one
- Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
Time to recharge
- A competitive paid time off plan – because rest fuels innovation.
- 12 weeks of fully paid parental leave so you can focus on family when it matters most.
Rewarding your impact
- Annual bonus opportunities for all full-time team members.
- 401(k) with company match to help you plan for the future.
- Special employee discounts, including childcare and dependent care savings.
Your wellness, supported
- Onsite fitness facility at The Hearth.
- Mental health counseling and financial planning services through our Employee Assistance Program.
- Employer-paid short and long-term disability coverage to protect your peace of mind.
Fuel for your workday
- A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what's next.
Grow with us
- Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
