Lead, Quality Systems - Columbus - Forge Biologics

Description

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. Whetheryou'rescaling AAV manufacturing, collaborating oncutting-edgetherapies, 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.

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.

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.
• 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.