Associate Director, Analytical Development & QC

Revolution Medicines seeks an Associate Director of Analytical Development & QC to oversee quality control testing at contract laboratories for oncology drug substances and products. The role involves vendor management, method validation, regulatory compliance, and leadership of commercial QC activities across development and late-phase programs.

Responsibilities

• Lead QC activities for late-phase and commercial programs including launch readiness and inspection preparation
• Oversee outsourced QC testing at contract manufacturers and external testing labs
• Manage quality events including out-of-specification investigations, deviations, and corrective actions
• Author and review QC-related documents such as methods, protocols, and technical reports
• Establish performance metrics, monitor trends, and drive continuous improvement initiatives

Requirements

• Bachelor's degree in scientific discipline with 15+ years pharmaceutical QC operations experience
• Master's degree with 12+ years or PhD with 10+ years acceptable alternative
• Deep knowledge of FDA, EU, and ICH regulatory guidelines for QbD and commercial manufacturing
• Experience managing outsourced QC at CDMOs and contract testing laboratories
• Proficiency with GMP deviations, CAPAs, out-of-specification investigations, and change controls
• Strong cross-functional collaboration and team leadership capabilities