Compliance Specialist Lead

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 Compliance Specialist Lead, to join the Forge Biologics team. This position will drive both the strategy and the delivery for Regulatory and Quality Compliance Initiatives, and this individual also oversees the GMP Internal Audit program. This person will support improvement initiatives related to the Quality Management Review (QMR), and support External Audit program, and processes to ensure Forge’s compliance with the appropriate regulatory agency requirements, internal company standards, client requirements, and current Good Manufacturing Practices (cGMPs).
Responsibilities:
Ownership of the Internal Audit process, planning, execution and verification of actions.
Support Regulatory Compliance/Quality Representatives and apply regulatory knowledge and judgment to identify potential compliance concerns and identify potential remediation action.
Track corrective actions as a result of audit observations and obtains and reviews objective evidence as actions are completed in accordance with prescribed commitments.
Support and update Site Governance and Standard Operating Procedures, Training and content/delivery. Promote audit/ inspection ready culture.
Support the coordination of Management Review includes monitoring the overall health of the Quality system through evaluation of KPIs, effectiveness checks, and risk management.
Partner with internal departments (e.g. Manufacturing, Quality, Facilities and Engineering) to ensure end-to-end compliance throughout the product lifecycle and commercial readiness.
Exemplifies good quality and compliance practices while championing Quality Culture throughout the organization.
Qualifications:
Bachelor’s degree in related discipline with 5+ years of compliance experience in a regulated industry (i.e., regulatory compliance experience in a pharmaceutical, biotech, or biologics GMP regulated manufacturing environment).
Excellent analytical, communication, and problem solving skills