Manager, QA Operations

📋 Description

• Review and manage master and executed packaging batch records from CMOs
• Review process validation protocols and reports
• Perform quality review of events (deviations, complaints, investigations)
• Manage lot release activities
• US-based role; quarterly visits to SF office
• Communicate packaging deficiencies to mgmt and coordinate with CMOs

🎯 Requirements

• Bachelors degree in a scientific discipline
• 5+ years of QA or QC in biotech or CRO
• Experience reviewing packaging master and executed batch records
• Strong organizational skills and multitasking
• Knowledge of FDA, EMA, ICH GxP regulations
• Travel ~10% of time

🎁 Benefits

• Market-leading compensation
• 401(k) with employer match
• Health Savings Account (HSA) with employer contributions; plus FSA
• 100% employer-paid medical, dental, and vision premiums
• Flexible PTO and company holidays
• Comprehensive paid medical and parental leave