Lead, Quality Systems
Company: Forge Biologics
Location: Columbus
Posted on: February 17, 2026
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Job Description:
Job Description Job Description Lead, Quality SystemsForge 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 Quality Systems
Lead provides strategic oversight and leadership within Forge's
Quality Systems organization. This role ensures the effectiveness,
compliance, and continuous improvement of Forge's quality
management systems in support of GMP operations. The Lead will
manage and mentor a team of specialists, driving execution of
quality events, documentation systems, and CAPA programs while
ensuring regulatory compliance and alignment with corporate quality
objectives. The ideal candidate demonstrates deep technical and
regulatory expertise, strong leadership, and the ability to
collaborate cross-functionally to strengthen Forge's culture of
quality and operational excellence. What You'll Do Provide
leadership and oversight for Quality Systems operations, including
documentation control, change control, deviations, CAPAs, and
investigations. Supervise and mentor Quality Systems Specialists
and Senior Specialists to ensure quality deliverables are completed
on time and meet compliance standards. Lead cross-functional
quality reviews, ensuring proactive identification and resolution
of systemic issues through root cause analysis and CAPA
effectiveness checks. Develop and implement improvements to Quality
Management System (QMS) workflows and documentation structures to
enhance efficiency and compliance. Review and approve complex
investigations, change controls, and controlled documents (SOPs,
Work Instructions, and Forms). Partner with Manufacturing, Quality
Control, and Process Development to ensure compliant, efficient
support of operational activities. Support audit readiness by
leading internal audit programs and representing Quality Systems
during external inspections. Drive a culture of continuous
improvement through quality metrics, trending, and data-driven
decision-making. Ensure Forge's QMS remains aligned with FDA, EMA,
and global regulatory expectations. What You'll Bring Bachelor's
degree in biological sciences, engineering, or a related STEM field
(Master's degree preferred). 8 years of relevant experience in GMP
Quality Systems, with 2 years of leadership or supervisory
experience. In-depth expertise in deviation management, change
control, CAPA, and root cause analysis. Strong working knowledge of
cGMPs, GDP, and global regulatory guidance (FDA, EMA, ICH).
Demonstrated ability to lead investigations and implement
sustainable process improvements. Excellent organizational,
communication, and leadership skills, with the ability to manage
multiple priorities in a fast-paced environment. Proficiency in
Quality Management Systems such as Veeva Vault QMS. Preferred
Experience supporting regulatory inspections and client audits.
Knowledge of global pharmacopeias (USP, EP, JP, BP, Ph. Eur.).
Experience with biologics, gene therapy, or sterile injectable
manufacturing. Familiarity with Lean or Six Sigma methodologies for
process improvement. 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.
Keywords: Forge Biologics, Middletown , Lead, Quality Systems, Science, Research & Development , Columbus, Ohio
