Senior Specialist, Quality Systems

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: 

 

The Senior Quality Systems Specialist provides quality systems and operational expertise for the Forge GMP facility in Grove City, OH. The Quality Systems Specialist will provide expertise and guidance in authoring, reviewing, and approving quality events such as deviations, CAPAs, change controls, and investigations. The Quality Systems Specialist will also be responsible for monitoring and improving the internal quality systems policies and workflows at Forge.  

 

Prior experience/specialized skills may result in additional responsibilities and/or development opportunities. The Sr. Quality Systems Specialist must demonstrate accountability, transparency, and effective communication cross-functionally and within the Quality team. 

 

What You’ll Do:

 

• Serve as a quality resource for quality system principles, including documentation control, change control, deviations, CAPAs, and investigations. 

• Proactively identify and implement items to enhance quality through continuous improvement (CAPA). 

• Make fact-based, scientifically and/or statistically sound, quality / regulatory compliant decisions that have impact on product release. 

• Author or review and approve investigations, CAPAs and change controls to drive for resolution through root cause analysis. 

• Author or review and approve controlled documentation including Standard Operating Procedures (SOPs), Work Instructions, and Forms. 

• Work with other technical groups to resolve issues, close gaps and seek quality compliant outcomes which are efficient and robust. 

• Support internal and external audits as needed. 

 

What You’ll Bring:

 

• Bachelor’s Degree (B.A. or B.S.) in biological or STEM-related field (or equivalent work experience)  

• Strong expertise in deviation management processes including in-depth root cause analysis and CAPA implementation. 

• Thorough knowledge and application of Good Documentation Practices (GDP). 

• Experience in a GxP environment. 

• Must be self-motivated, organized, and proactive. 

• Demonstrated knowledge and understanding of cGMP regulations and Food and Drug Administration (FDA) and EU requirements/guidance documents. 

• Ability to maintain a high degree of accuracy and attention to detail. 

• Ability to deliver results in a fast-paced, multi-tasking environment, and prioritize objectives effectively. 

 

Preferred Skills: 

 

• Experience with root cause analysis and investigations, including technical writing skills. 

• Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur. 

• Knowledge of biopharmaceutical manufacturing process workflows.