Director, Microbiology Quality Sterility Assurance

Director, Microbiology Quality Sterility Assurance leads the strategy and governance for sterility/aseptic assurance across manufacturing operations, embedding aseptic-by-design principles into product development, and partnering with CMOs. Responsible for remediation plans following regulatory observations, KPI trend analysis, and global CCS performance metrics; provides deep technical oversight of microbiological controls, terminal sterilization supplier qualification, and cross-site investigations with CAPA. Engages with regulators (FDA, EMA, MHRA) during inspections and regulatory filings, and supports external trade associations to advance industry best practices. Requires a Bachelor's degree in a scientific discipline, extensive aseptic/sterility experience in regulated environments, and 10+ years of leadership in globally distributed teams.