Lead, QA Operations

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 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.

Responsibilities:

• 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).
• Responsible for the leading, authoring, and reviewing of investigations, CAPAs and change controls to drive for resolution through root cause analysis.
• Responsible for the review and approval of controlled documentation including Standard Operating Procedures (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 team 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.

Qualifications:

• Bachelor’s Degree (B.A. or B.S.) in 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 as the GCPs, GMPs and GLPs.
• Proficiency in electronic quality management systems (eQMS) and document control software.
• Strong analytical and problem-solving skills, with the ability to analyze complex quality-related data and propose effective solutions.
• Ability to collaborate with diverse cross-functional technical groups to resolve issues, close gaps and ensure compliant outcomes which are efficient and robust.
• Excellent communication skills, including the ability to effectively communicate quality issues to senior management.
• Exceptional attention to detail and organizational skills to manage multiple priorities in a fast-paced environment.
• Ability to work hours necessary to support production and/or product transfer activities.
• Ability to work in confined spaces and near operating equipment.
• Ability to work onsite (Columbus, Ohio) 5 days/week.
• Ability to work in a cleanroom environment while wearing appropriate gowning and PPE.

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   

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area. Must be able to lift heavy objects up to 50 lbs. 

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.