Senior Manager, Quality Systems

About the role

The Senior Manager, Quality Systems is responsible for the management and improvement of the Quality Systems at Forge Biologics. This individual will provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to ensure compliance. The Senior Manager, Quality Systems will also be responsible for establishing and improving the internal Quality Systems business practices and workflows at Forge.

Responsibilities

• Manage quality events and continuous improvement of the Quality Systems including Investigations, Continuous Improvements, CAPAs, Change Controls, and other quality systems implemented at Forge.
• Facilitate the compiling, trending and reporting of key quality metrics for management, and other quality system functions.
• Responsible for implementation and compliance to schedule, conduct, and document Management Review, including preparation of the Management Review Agenda and Minutes.
• Communicate with other technical groups to resolve issues, identify and close gaps, and seek quality compliant outcomes which are efficient and robust.
• Responsible for the authoring or review and approval of controlled documentation including: Standard Operating Procedures (SOPs), Work Instructions, Guidance's, and other controlled document types.
• Making fast-based, scientifically and/or statistically sound, quality/regulatory compliant decisions that have impact on product release.
• Support hosting client/regulatory inspections, inspection readiness training, and reviewing audit reports and responses, as needed.

Requirements

• Bachelor's Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering, or related life science field (or equivalent professional experience).
• 10+ years of relevant experience Quality Systems within an FDA regulated field/industry.
• Prior leadership experience.
• Experience supporting inspections performed by FDA and/or foreign regulatory authorities.
• In-depth expertise in deviation management, change control, CAPA, and root cause analysis.
• Strong understanding of Quality Risk Management practices and procedures.
• Thorough knowledge of pharmaceutical cGMP requirements including strong working knowledge of FDA and EU requirements/guidance documents
• Proficiency in Quality Management Systems such as Veeva Vault QMS.
• Ability to work onsite in Columbus, Ohio, on average 1 week/month.
• 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

Benefits

Additional Information

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.

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