Lead, QA Operations

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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
, open
, purpose‑driven
, and engaged
. 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.

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.

The Lead, Quality Assurance Operations is responsible for the supervision and development of junior members of the Quality Assurance team and helping oversee GMP manufacturing activities. The Lead will provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance. The Lead will supervise junior members of the Quality Assurance team in activities such as document control, review of laboratory data, deviation management, internal & external audits, and training.

• Serves as a quality resource for operations departments.
• Responsible to make fact‑based, scientifically and/or statistically sound, quality / regulatory compliant decisions regarding products.
• Perform detailed review and approval of batch production records and associated documentation for AAV gene therapy manufacturing, ensuring adherence to established procedures and cGMP regulations.
• Effectively communicate to management quality issues that arise during the manufacturing of product.
• Proactively identify and implement items to enhance quality through continuous improvement (CAPA).
• Lead, author, and review investigations, CAPAs and change controls to drive resolution through root cause analysis.
• Review and approval of controlled documentation including SOPs, Work Instructions, Forms, Methods, Batch Records, etc.
• Develop and deliver comprehensive training programs to QA and manufacturing personnel on quality‑related topics, ensuring proper understanding and adherence to AAV gene therapy manufacturing procedures and regulatory requirements.
• Assist management in setting clear vision by ensuring goals and objectives are aligned with departmental goals and supervising each junior team member’s support.
• Oversee timecard reporting, task oversight, and scheduling as well as create and report metrics and internal KPIs.
• Provide supervision for employee relations through effective communications, coaching, training and development and eliminate roadblocks for the team to move forward.
• Supports regulatory audits as needed.

• Bachelor’s Degree (B.A. or B.S.) in a scientific‑related field or engineering (or equivalent work experience).
• 6‑8 years in a quality assurance role within the pharmaceutical or biotechnology industry.
• Experience mentoring and developing junior team members, including providing guidance on QA best practices and fostering professional growth.
• Experience in supporting internal and external audits.
• Thorough understanding of pharmaceutical cGMP requirements and strong working knowledge of FDA and EU requirements/guidance documents.
• Direct experience in providing QA support for cGMP manufacturing operations.
• Knowledge of drug development regulations such…