QA Manager, Batch Review and Disposition

The QA Manager will lead comprehensive batch reviews, make critical disposition decisions, and ensure compliance with regulatory requirements. The Manager will work closely with the Senior Director of Quality and lead cross-functional teams to champion batch review excellence and a culture of precision, scientific rigor, and timely product release decisions.

Requirements

• Lead comprehensive batch record review processes for sterile injectable drug products
• Make critical batch disposition decisions
• Establish and maintain batch review procedures
• Lead investigation of manufacturing deviations and out-of-specification results
• Collaborate with Quality Control to review analytical testing data
• Partner with Manufacturing Operations to review batch execution data
• Ensure compliance with cGMP requirements and regulatory expectations
• Develop and maintain batch review checklists and standard operating procedures
• Lead cross-functional batch review meetings
• Maintain batch disposition databases and generate reports
• Ensure readiness for regulatory inspections
• Train and develop team members on batch review processes
• Utilize electronic batch record systems and quality management systems
• Apply statistical analysis to identify trends in manufacturing performance and product quality

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Tuition Reimbursement
• Relocation Assistance