Director, Regulatory Compliance

About Forge  

Our mission at Forge Biologics, is to enable access to life changing gene therapies and help 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 Team 

The Regulatory Affairs department plays a critical role in ensuring that our products meet regulatory standards and compliance requirements to deliver safe and effective gene therapy solutions to patients. As a central hub for regulatory activities, our department is comprised of cross-functional teams, which include Quality Management, Quality Control, IT, and Compliance. Together, these departments collaborate closely to navigate the complex regulatory landscape, drive continuous improvement, and uphold the highest standards of quality and compliance in support of our mission to enable access to life changing gene therapy solutions for our patients.

 

About The Role 

We are currently seeking a Director of Regulatory Compliance (position title to be determined based upon experience)to join the Forge Biologics team. This is an exciting opportunity to contribute to the manufacture of life changing gene therapies for human use. The ideal candidate will be highly organized, experienced in project management, and have a keen attention to detail to contribute to the management of the quality system.  The Regulatory Compliance Director provides strategic leadership for quality culture, inspection readiness, clinical to commercial transition, and escalation process for the CDMO business unit. The role has specific focus on external and internal manufacturing/testing inspection readiness and ongoing compliance to changing regulatory expectations.

Regulatory Compliance is responsible for supporting regulatory agency and client responses following receipt of formal observation(s).  Regulatory Compliance will act as a champion for compliance with process design controls, good documentation practices, and risk management standards.  The individual is responsible for reviewing documents carefully to ensure that all requirements are clearly identified and required testing and/or manufacturing activities are planned to support needed regulatory and client compliance objectives.

Regulatory Compliance, as a function of Regulatory Affairs, drives the strategy and the delivery for Quality Management Reviews (QMR) and the Internal Audit (IA) program, and will develop and lead Annual Product Reviews (APR). This person will lead and drive all improvement initiatives related to the QMR, APR, and IA programs and processes to ensure Forge’s compliance with the appropriate regulatory agency requirements, internal company standards, client requirements, and current Good Manufacturing Practices (cGMPs) as a commercial supplier.

 

What You'll Do

• Leads as a Regulatory Compliance/Quality Representative for later phase and commercial manufacturing operations.
• Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into inspection readiness and control strategies.
• Applies regulatory knowledge and judgment to identify potential compliance concerns and identifies potential remediation action.
• Serves as a liaison with internal departments and external consultants and CROs  associated with all quality improvement initiatives.
• Oversees a team ensuring the timely delivery of Annual Product Reviews and Product Quality trending for all products.
• Oversees a team responsible for the Internal Audit process, including the Standard Operating Procedures, EQMS (i.e., Veeva) workflow, and training content/delivery.  This also includes monitoring the overall health of the system through evaluation of KPIs and periodic effectiveness checks.
• Stays abreast of the facility’s open CAPAs, ongoing audits, and general regulatory agency and client inspection preparedness.
• Oversees a team responsible for Management Review, which keeps facility staff informed of changes in regulations or