Quality Manager
Current▪ Wore multiple hats including QA, QC, Analytical Development, and project management to supportoverall CMC and Quality goals▪ Oversight and day-to-day management of outsourced GMP operations and vendor managementincluding quality questionnaires and quality agreements▪ Review and approve documents generated by vendors including batch production records,specifications, tech transfer reports, risk assessments, sampling and labeling plans▪ Manage and conduct multiple external audits▪ Final batch disposition of GMP materials and provided supports for vendor investigations, deviations,and change controls▪ Work cross-functionally and held vendors accountable for deliverables to meet internal criticaltimelines▪ Provided support to analytical method development and qualification process
