Manager, QA Operations

📋 Description

• Lead QA ops for commercial packaging at CSPs.
• Ensure GMP/GDP compliance in daily packaging ops.
• Review batch records and support lot disposition.
• QA review of deviations, changes, CAPAs, risk assessments.
• Input on tech transfer, process validation, shipping protocols.
• Escalate manufacturing issues and coordinate with CMOs.

🎯 Requirements

• Bachelor’s degree in a scientific field.
• 6+ years in biopharma with 4+ years in QA ops (cGMP).
• Strong knowledge of FDA regs (21 CFR 210/211), ICH, EU directives.
• Experience with serialization in US/global ops.
• Experience with Veeva platform preferred.
• Strong communication in matrix environments.

🎁 Benefits

• 100% employer-paid medical, dental, and vision for you.
• 401(k) with employer match.
• ESPP (Employee Stock Purchase Plan).
• Fertility and family-forming benefits.
• Hybrid work model with in-office days.
• Expanded mental health support and coaching.