Lead, Quality Systems

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. Ifyou’redriven 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, youwon’tjust watch innovation happen —you’llbe part of it. Whether you’rescaling AAV manufacturing, collaborating oncutting-edge therapies, or supporting complex technical projects,you’llplay 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 flowfreelyand 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’recommitted 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, andwe’reproud to see team members grow with us.

Ifyou’reready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself.

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.

• 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.

• 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.
• Proficienc…