Senior Director Quality Assurance

Job Summary

Leading GCP activities, the full-time Senior Director Quality Assurance will oversee strategic and tactical implementation of QA operations for clinical development programs, ensuring compliance with global health authority regulations, while working remotely or from San Diego or South San Francisco.

Key responsibilities

• Ensure clinical quality oversight for all clinical programs and readiness for commercialization
• Develop and manage a risk-based GCP audit program and compliance strategy for clinical studies
• Represent Clinical Quality during global regulatory inspections and provide quality guidance to stakeholders

Required qualifications

• Undergraduate degree in Biology, Chemistry, Physical Sciences, or related discipline preferred
• 12+ years of experience in GCP Quality management within a pharmaceutical or biotech environment
• Experience with quality for registrational clinical trials and transitioning to commercial quality systems
• Extensive knowledge of ICH GCP guidelines and global regulatory requirements governing drug development
• Demonstrated ability to achieve high performance goals in a fast-paced environment