Senior Director of Quality Assurance

Job Summary

Leading a global team of QA professionals, the full-time Senior Director of Quality Assurance will provide oversight for clinical trials, direct the Clinical QA program, and ensure compliance with international regulatory requirements while supporting the broader Quality Management System in a remote work environment.

Key responsibilities

• Provide leadership to enhance the global risk-based Clinical Quality Assurance strategy for regulatory compliance
• Lead the design and execution of the internal audit program to ensure QMS compliance
• Manage the customer audit program, ensuring audit readiness and effective hosting of qualification audits

Required qualifications

• Bachelor's Degree in Life Sciences, Pharmacy, Nursing, or a related field
• 12+ years of experience in the pharmaceutical, biotechnology, or CRO industry
• 7+ years of experience in a Clinical Quality Assurance role
• 5+ years of direct people management experience, including leading global teams
• Certification as a Quality Auditor or equivalent preferred