QA Operations Lead, AAV Manufacturing

Forge Biologics; Columbus (OH); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Annual bonus opportunities

Onsite fitness facility

Job summary

Forge Biologics is seeking an Associate Manager of QA Operations for AAV Manufacturing on the 2nd shift in Columbus, OH. This role leads junior QA staff, ensures cGMP compliance, and facilitates batch record reviews within a state-of-the-art AAV production environment.

The candidate will partner with Process Development and Manufacturing to drive continuous improvements, manage deviations, CAPAs, and support internal/external audits.

Qualifications

• Bachelor’s Degree in scientific field or engineering.
• 6+ years in QA or related role in pharma/biotech.
• Experience mentoring junior team members and QA best practices.
• Strong knowledge of cGMP and FDA/EU guidance documents.
• Experience with electronic QMS (Veeva Vault preferred).
• Ability to collaborate cross-functionally to resolve issues and ensure compliant outcomes.

Responsibilities

• Oversee GMP AAV Manufacturing operations in cleanroom environment and communicate quality issues.
• Supervise QA team, manage timecards, training and scheduling.
• Review batch records and maintain controlled documentation per procedures and cGMP.
• Collaborate with Process Development, Analytical Development, and Manufacturing for process improvements.
• Support deviations and CAPA with root cause analysis.
• Assist in external audits and inspections for AAV gene therapy manufacturing.

Skills

QA leadership

GMP compliance

Cross-functional collaboration

Document control

FDA/EU guidelines

CAPA/root cause analysis

Education

Bachelor’s Degree in science/engineering

Tools

Veeva Vault

Electronic Quality Management System

Job description

Forge Biologics is seeking an Associate Manager of QA Operations for AAV Manufacturing on the 2nd shift in Columbus, OH. This role leads junior QA staff, ensures cGMP compliance, and facilitates batch record reviews within a state-of-the-art AAV production environment.

The candidate will partner with Process Development and Manufacturing to drive continuous improvements, manage deviations, CAPAs, and support internal/external audits.