About The Role:   

As a Technical Training Manager within the Quality Management Training team, you’ll play a lead role in training and developing associates on GMP-regulated processes that support our AAV Manufacturing operations. Reporting to the Director, GMP Quality Training, you’ll own the delivery of training through hands-on and classroom instruction, actively observe performance, and mentor associates to ensure they are trained, qualified, and confident in their work. You’ll lead qualification and requalification activities, document results in compliance with GDP, and maintain your own process and gowning qualifications to serve as a subject matter expert. While this position is primarily focused on training delivery and mentoring, you’ll also shape the program by identifying training gaps, sharing feedback with supervisors, and recommending improvements to strengthen training methods, content, and overall effectiveness. 

Responsibilities: 

Training Delivery and Qualification: 

• Serve as a subject matter expert and technical lead for GMP Manufacturing operations, owning the delivery of training through classroom instruction, one-on-one coaching, and hands-on, on-the-job practice. 

• Mentor associates throughout their development, actively observe and evaluate performance, and ensure their successful transition to independent work. 

• Coordinate and lead qualification and requalification activities by assessing proficiency, verifying proper execution of GMP-regulated processes, and ensuring all results are accurately documented in compliance with GDP. 

Training Coordination and Compliance: 

• Take ownership of Manufacturing training program compliance by providing clear, actionable feedback to associates and management on training progress, performance observations, and identified gaps. 

• Be accountable for upholding GMP/GDP expectations through accurate qualification documentation and consistent reinforcement of training standards. 

• Be cross-trained in the Training Management System (e.g., Veeva Vault) to provide oversight and ensure accuracy in recordkeeping, compliance tracking, and reporting when required. 

Program Development and Content Management: 

• Take ownership of developing and maintaining training programs that directly support Manufacturing, working in close partnership with Manufacturing leadership and the Training team. 

• Lead the design of area-specific training content, on-the-job training initiatives, and qualification processes to ensure associates are fully prepared for independent work. 

• Own the revisions, updates, and periodic reviews of training materials, ensuring they remain current with SOPs, process changes, and continuous improvement activities. 

Continuous Improvement and Support: 

• Take ownership of continuous improvement within training programs by monitoring effectiveness, proactively communicating findings to leadership, and driving remediation or enhancements where needed. 

• Identify training gaps, recommend improvements, and implement stronger training methods to elevate associate performance and compliance. 

• Maintain gowning and manufacturing process qualifications to serve as a subject matter expert and technical lead during training activities, ensuring associates are consistently prepared for independent work. 

Qualifications: 

• Associate’s degree in Life Sciences, Biotechnology, or a related technical field required; Bachelor’s degree strongly preferred. Equivalent experience may be considered. 

• 3-5 years of experience in GMP-regulated manufacturing (biotech, pharmaceutical, or medical device), with advanced knowledge of AAV bioprocess manufacturing and aseptic techniques/practices. 

• Demonstrated experience leading training activities, mentoring associates, and serving as a recognized Subject Matter Expert within Manufacturing operations. 

• Proven ability to deliver hands-on, on-the-job training and conduct qualification assessments in compliance with GMP/GDP requirements. 

• Advanced communication and facilitation skills, with the ability to simplify complex technical concepts and engage diverse audiences. 

• Experience working cross-functionally with Manufacturing, Quality, Process Development, and Training teams to align training with both business objectives and compliance requirements. 

• Strong organizational and leadership skills, with the ability to manage multiple training priorities and influence program outcomes. 

• Knowledge of adult learning principles and training design methodologies (e.g., ADDIE). 

• Ability to work onsite in Columbus, Ohio 3-4 days/week on average. 

• Ability to work in a cleanroom environment, that requires wearing full Personal Protective Equipment (PPE), including gowns, gloves, masks, and safety glasses. 

Preferred Skills: 

• Demonstrated success in leading training initiatives, mentoring associates, and serving as a recognized SME within GMP-regulated environments. 

• Expertise in AAV bioprocess manufacturing, including cell culture operations, aseptic techniques, and cleanroom behaviors. 

• Proficiency with electronic training systems such as Veeva Vault or similar platforms, with the ability to interpret and leverage training data. 

• Proven ability to identify training gaps, recommend improvements, and implement enhancements that strengthen program effectiveness. 

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.  

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 Senior Quality Systems Specialist provides quality systems and operational expertise for the Forge GMP facility in Grove City, OH. The Quality Systems Specialist will provide expertise and guidance in authoring, reviewing, and approving quality events such as deviations, CAPAs, change controls, and investigations. The Quality Systems Specialist will also be responsible for monitoring and improving the internal quality systems policies and workflows at Forge.  

Prior experience/specialized skills may result in additional responsibilities and/or development opportunities. The Sr. Quality Systems Specialist must demonstrate accountability, transparency, and effective communication cross-functionally and within the Quality team. 

What You’ll Do:

• Serve as a quality resource for quality system principles, including documentation control, change control, deviations, CAPAs, and investigations. 

• Proactively identify and implement items to enhance quality through continuous improvement (CAPA). 

• Make fact-based, scientifically and/or statistically sound, quality / regulatory compliant decisions that have impact on product release. 

• Author or review and approve investigations, CAPAs and change controls to drive for resolution through root cause analysis. 

• Author or review and approve controlled documentation including Standard Operating Procedures (SOPs), Work Instructions, and Forms. 

• Work with other technical groups to resolve issues, close gaps and seek quality compliant outcomes which are efficient and robust. 

• Support internal and external audits as needed. 

What You’ll Bring:

• Bachelor’s Degree (B.A. or B.S.) in biological or STEM-related field (or equivalent work experience)  

• Strong expertise in deviation management processes including in-depth root cause analysis and CAPA implementation. 

• Thorough knowledge and application of Good Documentation Practices (GDP). 

• Experience in a GxP environment. 

• Must be self-motivated, organized, and proactive. 

• Demonstrated knowledge and understanding of cGMP regulations and Food and Drug Administration (FDA) and EU requirements/guidance documents. 

• Ability to maintain a high degree of accuracy and attention to detail. 

• Ability to deliver results in a fast-paced, multi-tasking environment, and prioritize objectives effectively. 

Preferred Skills: 

• Experience with root cause analysis and investigations, including technical writing skills. 

• Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur. 

• Knowledge of biopharmaceutical manufacturing process workflows. 

• Experience supporting inspections performed by FDA and foreign Regulatory Authorities. 

• Experience within a pharmaceutical, biotech, or related industry. 

• Sterile injectable pharmaceuticals or biologics experience is preferred.  

• Experience with Veeva Vault QMS. 

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.