Associate Manager, QA Operations - AAV Manufacturing (2nd Shift)
Core
Supervising junior QA team members and overseeing AAV GMP manufacturing activities to ensure compliance and quality standards.
Role type
Associate Manager, Quality Assurance (Manufacturing)
Builds
AAV gene therapy products for patients with genetic diseases
Domain
Biotechnology / Gene Therapy / cGMP Manufacturing
Required skills
QA team supervision, batch record review, cGMP compliance, deviation/CAPA management, audit support, cross-functional collaboration, timecard/scheduling management
Preferred skills
Cleanroom QA experience, biologics/gene therapy production, CDMO operations, internal/external audit support
Technologies
Veeva Vault, Microsoft Office (Outlook, Teams, Word, Excel, PowerPoint)
Responsibilities
Supervise junior QA members on document control and batch record review; Provide quality guidance and make compliant decisions in the cleanroom; Collaborate with Process/Analytical Development for continuous improvement; Support SOP and batch record creation/review; Assist with root cause analysis and CAPA; Prepare for external audits and inspections
Seniority
Mid-Senior, hands-on IC with people management