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Forge Biologics is seeking an Associate Manager, Quality Assurance for AAV Manufacturing to join their team at The Hearth, a state-of-the-art 200,000-square-foot cGMP facility in Columbus, Ohio. This is a management role on the 2nd shift, responsible for supervising and developing junior members of the Quality Assurance team while overseeing AAV GMP manufacturing activities.
In this role, you will serve as a quality resource for the GMP AAV Manufacturing department, directly overseeing operations in the cleanroom manufacturing environment. You will provide guidance and ensure effective communication of quality issues that arise during product manufacturing, making fact-based, data-driven, compliant decisions regarding products and processes.
Key responsibilities include:
- Supervising junior QA team members through effective communication, coaching, training, and development; eliminating roadblocks and setting clear vision aligned with departmental goals
- Overseeing timecard reporting, task oversight, and scheduling for your team
- Performing detailed review and approval of batch records, associated documentation, logbooks, and controlled documentation for AAV gene therapy manufacturing, ensuring adherence to established procedures and cGMP regulations
- Collaborating with cross-functional teams (Process Development, Analytical Development, Manufacturing) to support continuous process improvement initiatives
- Supporting the documentation control process, including creation, revision, review, and approval of batch records, SOPs, work instructions, and forms
- Supporting deviations and continuous improvements related to AAV gene therapy manufacturing; assisting with root cause analysis and identification of CAPA measures
- Assisting in preparation for external audits and inspections, supporting regulatory agencies or client audits specific to AAV gene therapy manufacturing
The position is performed in a temperature-controlled laboratory or office environment and requires regular standing, hand manipulation, and use of laboratory equipment. You may lift or move materials up to 25 pounds and occasionally reach or handle materials at various heights. Appropriate PPE must be worn when working with chemicals, biological materials, or in controlled environments.
Forge Biologics offers comprehensive benefits including health, dental, and vision insurance (90% of premiums covered for employee and family starting day one), competitive paid time off, 12 weeks of fully paid parental leave, annual bonus opportunities, 401(k) with company match, onsite fitness facility, mental health counseling and financial planning services through an Employee Assistance Program, employer-paid short and long-term disability coverage, free snacks and beverages, and ongoing professional development resources and mentorship programs.
**Requirements:**
- Bachelor's Degree (B.A. or B.S.) in a scientific-related field or engineering (or equivalent work experience)
- 6+ years in a Quality Assurance or related role within the pharmaceutical industry
- Experience with cGMP regulations and compliance
- Experience with batch record review and documentation control
- Experience in a supervisory or leadership capacity
- Knowledge of AAV gene therapy manufacturing is preferred
- Ability to work 2nd shift
