Supplier Quality Specialist

Forge Biologics•Columbus, OH

About The Position

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.

Requirements

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.
Strong organizational skills, attention to detail, and adherence to Good Documentation Practices.
Ability to engage with technical and scientific personnel and manage supplier relationships.
Comfortable operating independently and collaboratively with internal and external partners, in a fast‑paced, patient‑focused manufacturing environment with changing priorities and deadlines.
Ability to travel between 10-25% and work the hours necessary to support production and/or product transfer activities.

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.

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.