Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid)

Role: Associate Director, CMC Quality Compliance and Inspection Readiness, overseeing inspection preparedness and compliance for external sites within biopharma operations. Responsibilities: lead cross-functional efforts to ensure sites achieve ongoing inspection readiness, identify and resolve compliance gaps, manage inspection activities including CAPA responses, foster collaboration across functions and external partners, and drive continuous improvement initiatives. Requirements: Bachelor's in a scientific or health-related field; 8+ years relevant experience in quality compliance, inspection management, or related areas. High-Value: global regulatory standards, inspection risk management, multiple modalities preferred, experience with continuous improvement methods (e.g., Six Sigma or Lean). WorkSetup: hybrid or on-site; travel up to 20%, including international. Focus on supporting commercial-level quality culture, external site oversight, and operational excellence.