Lead, Quality Systems

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
, open
, purpose‑driven
, and engaged
.

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.

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.

• 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.
• Proficiency in Quality Management Systems such as Veeva Vault QMS.

• 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.

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 indoor environmental conditions having…