The Senior Director of Quality, Quality Site Head is accountable for raw material release, Quality on the floor, disposition of drug substance, QA review of quality control data, root cause analysis, risk management, deviation, Change Control and CAPA management, document/records management, quality metrics reporting, data integrity, training management, QA review of method qualification/validation, process qualification/validation, and equipment/utilities/ facilities qualification and continuous improvement. He/she is responsible for oversight of QC Microbiology tasks including Bioburden, Endotoxin, TOC Conductivity, Water collection Osmolality, EM collection and testing, Organism/Media QC, EM Trending, Sample Accessioning, and Raw Material Program Management.