Senior Director, Quality Systems

Kailera is seeking a Senior Director, Quality Systems to lead the architecture, implementation, and continuous improvement of its Enterprise Quality Management System (eQMS) to support global clinical development and commercialization. The role requires expertise in Quality Assurance within the Biotech/Pharmaceutical industry, specifically in implementing or managing Veeva QualityVault, navigating global GxP regulations, and leading regulatory inspections.

Requirements

• Define and execute the long-term vision for the Quality Management System (QMS)
• Provide Quality oversight for GxP systems change controls
• Act as the Business Owner for Veeva QualityVault
• Establish and lead Quality Management Reviews (QMR)
• Ensure the QMS meets global regulatory requirements
• Lead the QMS strategy for inspection readiness

Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities
• Equity grants