Senior Manager, Quality Assurance

Job Summary

A company is looking for a Senior Manager, Commercial Product Quality.

Key Responsibilities

• Provide strategic and operational quality leadership across Chemistry, Manufacturing, and Controls (CMC) to ensure compliance with global Good Manufacturing Practice (GMP) requirements
• Oversee GMP activities including batch disposition, deviation management, change control, and validation while identifying and mitigating quality and compliance risks
• Establish and strengthen quality systems, driving continuous improvement initiatives and ensuring alignment with regulatory expectations

Required Qualifications and Education

• Bachelor's degree in a relevant scientific discipline; advanced degree preferred
• 8+ years of experience in Quality within the pharmaceutical or biotechnology industry
• Strong understanding of GMP, Quality Management Systems, and Regulatory frameworks (FDA, EMA, ICH guidelines)
• Demonstrated success in driving continuous improvement initiatives and achieving measurable results
• Experience in risk management, root cause analysis, and CAPA processes