Sr. Manager, QA Operations

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

What You’ll Do  

• Author, review and approval of controlled documentation including: Batch Records, Standard Operating Procedures (SOPs), Work Instructions, Forms, Methods, etc.
• Serves as a quality resource for operations departments, providing on-the-floor, real-time oversight during manufacturing operations.
• Support investigations, CAPAs and change controls; ensuring timely closure and root cause analysis of issues.
• Partner with other technical groups to resolve issues, close gaps and seek quality compliant outcomes which are efficient and robust.
• Accountable for making timely, scientifically and statistically sound decisions regarding product quality, including regulatory-compliant material disposition determinations.
• Effectively communicate to management any quality issues that arise during the manufacturing of product.
• Proactively identify and implement items to enhance quality through continuous improvement (CAPA).
• Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member’s performance.
• Manage, mentor, and develop QA Operations team by fostering a culture of accountability, continuous development, and removing obstacles to facilitate team progress.
• Preparing for and supporting regulatory inspections, client audits, and internal audits as needed.

What You’ll Bring  

• Bachelor’s Degree (B.A. or B.S.) in a related scientific field.
• Minimum 10+ years of progressive experience supporting QA Operations, within regulated manufacturing environments.
• Direct experience providing QA oversight for cGMP manufacturing operations, preferably with a CDMO.
• Knowledge of drug development regulations such as the GCPs, GMPs and GLPs.
• At least 3+ years of direct leadership experience.
• Strong working knowledge of FDA and EU requirements / guidance documents.
• Experience in supporting regulatory audits.
• 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.
• Ability to work onsite 5 days/week.

Work Environment and Physical Demands  

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 wi