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
What You'll Bring
Preferred Skills
Work Environment and Physical Demands
This position works in a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. This is largely a sedentary role; persons holding office positions are generally subject to inside environmental conditions having the lighting, temperature, and noise of an open floor-plan office environment. Regularly operate a computer and other office equipment. Regularly communicate with others in person, over the phone, and electronically. Must be able to move and/or carry objects weighing up to 10 lbs.
Travel on an infrequent basis is required (0 to 5%) to support job responsibilities and commitments.
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.