Manager/ Sr. Manager, Regulatory Compliance

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: 

We are currently seeking a Manager/ Sr. Manager of Regulatory Compliance to join the Forge Biologics team. This position will drive both the strategy and the delivery for Regulatory and Quality Compliance Initiatives, and this individual also oversees the GMP External Audit program. This person will lead improvement initiatives related to the Quality Management Review (QMR), and support Internal Audit 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). 

 

What You’ll Do: 

• Serves as a Regulatory Compliance/Quality Representative and applies regulatory knowledge and judgment to identify potential compliance concerns and identifies potential remediation action. 
• Support cGMP Operations, regulatory agency and client responses following receipt of formal observation(s).
• Ownership of the Client Audit process, planning, execution and follow up actions.
• Support and update Site Governance and Standard Operating Procedures, Training and content/delivery. Promote audit/ inspection ready culture.
• Through Management Review, keep facility staff informed of changes in regulations or international standards that may affect products and operations. This also includes monitoring the overall health of the Quality system through evaluation of KPIs and periodic effectiveness checks.
• Reviews documents to ensure that all requirements are clearly identified and that required testing and/or manufacturing activities are planned to support needed regulatory and client compliance objectives. 
• Supports regulatory agency and client interactions/audits and responses following receipt of formal observation(s). 
• Tracks corrective action activities for audit observations and obtains and reviews objective evidence as actions are completed in accordance with prescribed commitments. 

 

What You’ll Bring: 

• Bachelor’s degree in related discipline with 5+ years of compliance experience in a regulated industry (i.e., regulatory compliance experience in a pharmaceutical, biotech, or biologics GMP regulated manufacturing environment). 
• Experience with CAPA’s and audit practices and strategies. 
• Experience interacting with domestic and international regulatory agencies. 
• Working knowledge of quality systems and ability to apply GMP’s in conformance to U.S. and Global standards, and where appropriate, other regulatory authority standards. 

 

Work Environment and Physical Demands  

his 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. 

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce