Training Systems Specialist

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:  

As the Training Systems Specialist within the GMP Quality Training team, you’ll serve as a subject matter expert in training system administration and compliance reporting. Reporting to the Senior Technical Training Manager, you will own the daily operations of the training management system (Veeva Vault), ensuring accuracy in assignments, curricula, records, and compliance metrics. You’ll lead the development of training reports, dashboards, and trend analyses that inform leadership decisions and support regulatory inspection-readiness. In addition, you’ll deliver training system instruction to employees at all levels, facilitate GMP/GDP training sessions, and drive continuous improvement initiatives that strengthen compliance, learner engagement, and training effectiveness.

Responsibilities:

Training System Administration, Compliance, and Reporting:

• Independently manage the administration of the training management system, ensuring accuracy of training assignments, curricula, user records, and completion of data. 

• Oversee and implement updates related to new documents, role changes, and departmental requests in full alignment with GMP/GDP requirements and internal SOPs. 

• Act as a primary point of contact for troubleshooting and provide subject matter expertise to end users, resolving complex inquiries and system issues. 

• Lead routine and ad-hoc data integrity reviews, resolve discrepancies, and coordinate the testing and implementation of system enhancements or configuration changes.

•  Ensure all training activities are documented and maintained in strict compliance with regulatory requirements, serve as a lead resource during audits and inspections by preparing records and demonstrating system functionality, and partner with Quality leadership on inspection readiness. 

• Develop and maintain advanced reports and dashboards, conduct in-depth analysis of training data, and present insights and recommendations to management to support compliance monitoring, strategic planning, and continuous improvement initiatives. 

Training Facilitation & Support:

• Lead the delivery of system training for all team members on training management system workflows and functionalities as needed.

• Independently facilitate GMP/GDP classroom sessions and workshops, tailoring content to diverse audiences and ensuring consistency with compliance expectations.

• Oversee training logistics by coordinating schedules, preparing materials, managing room setup, and verifying accurate attendance tracking, while also coaching others in best practices for training delivery and documentation.   

Continuous Improvement:

• Lead process improvement initiatives by analyzing system performance, identifying gaps, and implementing enhancements to training processes and reporting capabilities.

• Proactively gather and evaluate feedback from end users, recommend solutions, and drive the adoption of best practices that strengthen compliance, efficiency, and learner engagement.

• Partner with cross-functional teams to design and implement improvements that optimize system utilization and enhance the overall training experience across the organization. 

Qualifications:

• Associates degree or higher in Life Sciences, Education, or a related field (or equivalent professional experience). 

• 3+ years of progressive administrative or coordination experience with a strong focus on data accuracy, recordkeeping, and compliance. 

• Experience in training coordination, learning systems administration, and/or quality system support. 

• Demonstrated experience with a Learning Management System (LMS) or Training Management System (TMS), with the ability to troubleshoot, configure, and train others on system functionality. 

• Prior experience preparing for and supporting audits or regulatory inspections through training records and system demonstrations. 

• Proven ability to develop reports, analyze training metrics, and provide insights that inform compliance and business decisions. 

• Ability to work onsite 4 days/week on average.

Preferred Skills:

• Strong knowledge of GMP/GDP compliance requirements and training documentation practices, with the ability to apply them independently in daily operations. 

• Advanced experience with Veeva Vault or similar electronic training systems, including troubleshooting, configuration, and user training. 

• Demonstrated ability to develop or refine training processes that enhance compliance and system efficiency. 

• Experience preparing for and supporting regulatory audits and inspections as the primary training system contact. 

• Experience in a regulated industry (biotech, pharmaceutical, or medical device). 

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 both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.

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.