Associate Director Quality Assurance

Job Summary

A company is looking for an Associate Director of Quality Assurance, GCP (contract).

Key Responsibilities

• Establish and maintain quality programs to ensure compliance with international regulatory standards
• Represent Quality Assurance on cross-functional clinical study teams
• Conduct and oversee GxP vendor audits and manage audit schedules and reports

Required Qualifications

• Undergraduate degree in Biology, Chemistry, Physical Sciences, or related discipline, or comparable experience
• 10 years of experience in managing GxP Quality/Compliance audits in a pharmaceutical or biotech environment
• Extensive knowledge of ICH Guidelines and regulatory requirements for drug development
• Experience with transitions from Phase 1-3 to commercial quality systems preferred
• Previous experience with FDA and regulatory agency inspections of clinical research activities