Lead, Quality Systems

Forge Biologics • Columbus, OH

15h • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level