Supplier Quality Specialist

Описание вакансии

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.
• 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.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned.

Work Environment and Physical Demands

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.

We’ve Got You Covered:

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.

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.