Senior Director of Quality Assurance

Job Summary

A company is looking for a Senior Director, Quality Assurance.

Key Responsibilities

• Oversee the development and maintenance of a Quality Management System compliant with regulatory requirements
• Lead Management Reviews and quality metrics reporting to monitor system performance and identify improvement areas
• Manage vendor oversight through audits and ensure the organization maintains Inspection Readiness

Required Qualifications

• Bachelor's degree in a related science discipline; advanced degree preferred
• 15+ years of experience in the Pharmaceutical/Biopharmaceutical industry, with at least 5 years in a leadership role
• In-depth knowledge of FDA guidelines and experience in implementing these in fast-growing environments
• Strong working knowledge of cGMP environments and evolving quality systems
• Demonstrated leadership in building functions and infrastructure within quality management