Manager, Quality Operations, CMC

Role: Manager, Quality Operations, CMC, overseeing product quality for clinical and commercial biopharma programs, focusing on drug substance, drug product, packaging, and external manufacturing partners. Responsibilities: end-to-end quality oversight, reviewing critical documentation, managing deviations, CAPAs, product disposition activities, and representing Quality in cross-functional teams supporting development, launch, and regulatory compliance. Requirements: BA/BS in a scientific discipline; 6+ years in GMP-regulated pharma supporting small-molecule manufacturing; strong GMP knowledge aligned with FDA, EMA, ICH standards; hands-on experience with batch disposition, deviations, change control, and supplier audits; experience supporting health authority inspections. HighValue: supports small-molecule drug development, clinical and commercial stages; involved in manufacturing, validation, and lifecycle management, with emphasis on risk-based decision-making and regulatory readiness. WorkSetup: remote with travel (~15–20%) as needed.