Supplier Quality Specialist

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, 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: 

We are currently seeking a Supplier Quality Specialist to join the Forge Biologics team. In this role, you will take ownership of critical supplier quality activities, including supplier qualification, performance monitoring, and audits. You will play a key role in driving continuous improvement of our risk-based supplier quality management program and act as a primary liaison with suppliers to ensure compliance with GMP and Forge quality standards. This is an excellent opportunity for an experienced quality professional to grow their expertise, influence supplier performance, and directly contribute to the delivery of life changing gene therapies for patients.

Responsibilities:

• Execute and oversee quality oversight responsibilities of GMP suppliers and service providers, ensuring compliance with Forge quality standards.
• Contribute to the design, implementation, and continuous improvement of the risk-based supplier quality management program; serve as a key resource for periodic review and updates of established procedures.
• Manage supplier reporting systems, analyze data, and prepare supplier performance metrics and risk determinations with actionable recommendations.
• Act as a primary contact for assigned suppliers—building effective partnerships, facilitating quality and supply chain information exchange, and driving resolution of supplier-related issues.
• Lead the qualification and ongoing management of suppliers and service providers, including conducting risk assessments and monitoring performance trends.
• Drive supplier change notifications and complaint/corrective action processes through cross-functional collaboration and root cause analysis.
• Support internal and external regulatory inspections related to supplier quality. Other duties as assigned.

Qualifications:

• Bachelor’s degree in Biology, Life Sciences, or related discipline (or equivalent professional experience).
• 3–5 years of experience in Quality Assurance, Supplier Quality, or similar GMP-regulated roles.
• Proficiency in Quality Systems and ability to apply GMP’s in conformance with U.S. and international standards.
• Experience interacting with suppliers, with a solid understanding of supplier audit practices and risk-management strategies; prior audit experience is preferred.
• Experience applying cGMP principles within pharmaceutical, biotech, or related industries.
• Excellent interpersonal, verbal, and written communication skills; able to influence and collaborate across functions.
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