Sr. Manager, Quality Assurance

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. Manager, Quality Assurance is responsible for the development and management of the Quality Assurance team at Forge Biologics. The Quality Assurance team includes oversight of the GMP Manufacturing space as well as the laboratories. The Sr. QA manager will provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. The Sr. QA Manager will also be responsible establishing and improving the internal Quality policies that provide oversight of the GMP manufacturing area.

What You’ll Do  

• Must be thoroughly knowledgeable with pharmaceutical cGMP requirements including strong working knowledge of FDA and EU requirements / guidance documents.
• Partner with other technical groups to resolve issues, close gaps and seek quality compliant outcomes which are efficient and robust.
• Serves as a quality resource for operations departments.
• Responsible to make prompt, scientifically and/or statistically sound, quality / regulatory compliant decisions regarding products including material disposition decisions.
• 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 authoring or review and approval of investigations, CAPAs and change controls to drive for resolution through root cause analysis.
• Responsible for the authoring or review and approval of controlled documentation including: Standard Operating Procedures (SOPs), Work Instructions, Forms, Methods, Batch Records, etc.
• Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member’s performance management.
• Provide leadership in employee relations by fostering effective communication, offering coaching and training, supporting development, and removing obstacles to facilitate team progress.
• Supports internal and external audits as needed.

What You’ll Bring  

• Bachelor’s Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience).
• Experience in a Quality role in a GxP regulated industry.
• Direct experience in providing QA oversight for cGMP manufacturing operations.
• Knowledge of drug development regulations such as the GCPs, GMPs and GLPs.
• Previous leadership experience.
• Experience in supporting regulatory audits.
• Must be self-motivating, organized, and proactive.
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• Ability to effectively communicate quality issues to senior leadership.
• Strong interpersonal skills to work with a diverse team.
• Ability to work hours necessary to support production and/or product transfer activities.
• Ability to work in confined spaces and near operating equipment.
• Comfortable working onsite 5 days/week.

Work Environment and Physical Demands  

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