Senior Quality Systems Specialist

 

About Forge  

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.   

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.  

 

About the Role 

The Sr. Quality Systems Specialist provides advanced quality systems expertise and operational support for Forge’s GMP facility in Grove City, OH. This role serves as a subject matter expert (SME) in deviation management, CAPA, change control, and investigations, and drives continuous improvement within the Quality Management System (QMS). The Sr. Specialist partners cross-functionally to ensure quality standards are met, compliance is maintained, and processes are efficient and robust. 

 

What You’ll Do  

• Serve as a primary SME for quality system processes, including documentation control, change control, deviations, CAPAs, and investigations. 
• Lead or review complex investigations, applying in-depth root cause analysis and implementing effective, sustainable CAPAs. 
• Review and approve controlled documentation, including Standard Operating Procedures (SOPs), Work Instructions, and Forms. 
• Collaborate with technical teams to resolve quality issues, close process gaps, and drive compliant, efficient solutions. 
• Identify and lead continuous improvement initiatives to enhance quality and operational efficiency. 
• Support internal and external audits and regulatory inspections, providing subject matter expertise as needed. 
• Make fact-based, scientifically and/or statistically sound, regulatory-compliant recommendations that may impact product quality decisions. 

 

What You’ll Bring 

• Bachelor’s Degree (B.A. or B.S.) in biological or STEM-related field (or equivalent work experience)  
• Extensive experience in deviation management, root cause analysis, and CAPA implementation. 
• Thorough knowledge and application of Good Documentation Practices (GDP). 
• Demonstrated expertise in cGMP regulations and FDA/EU requirements and guidance. 
• Experience working in a GxP environment, preferably in biopharmaceutical manufacturing. 
• Strong organizational skills with a high degree of accuracy and attention to detail. 
• Ability to work proactively in a fast-paced environment, managing multiple priorities effectively. 
• Strong interpersonal and communication skills with the ability to influence and collaborate across functions. 

Preferred Skills 

•  Experience supporting FDA and international regulatory inspections. 
• Working knowledge of global pharmacopeias (USP, EP, JP, BP, Ph. Eur.). 
• Knowledge of biopharmaceutical manufacturing workflows, including sterile injectable pharmaceuticals or biologics. 
• Proficiency with Veeva Vault QMS or other electronic quality management systems. 
• Technical writing skills for investigations, CAPAs, and regulatory documentation 

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. 

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. 

 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. 

Life at Forge  

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge’s core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.  

 

HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key. 

OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback. 

PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies. 

ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge’s vision, mission and goals. 

 

We’ve Got You Covered 

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable. 

Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents 

Competitive paid time off plan 

Annual bonus for all full-time employees 

401(K) company match 

Fully-stocked kitchen with free food/drinks 

12 weeks of paid parental leave - additional discount programs include childcare support & dependent care 

Employee Assistance Program  

Wellness benefits (financial planning services, mental health counseling, employer paid disability) 

Onsite fitness facility  

Professional & Personal development resources