Director

• Manage lifecycle of QC critical reagents and reference standards at all stages of product development
• Synchronize change management of critical reagents/materials and reference standards across multiple vendor sites in alignment with program team requirements
• Perform technical review of material qualification and re-evaluation protocols, reports, and analytical data received from vendors
• Coordinate QC material and sample shipments to support analytical testing activities at vendor sites
• Author controlled documents to support QC systems and infrastructure
• Overall responsibility for LIMS system administration for QC team
• Manage QC LIMS system changes, including updates to system master data (specifications, methods, reporting units) and workflows (automated data parsing/upload, data approval, reporting workflows)
• Support computer system validation and change control activities for LIMS system upgrades and enhancements in partnership with QA team and SaaS provider(s)
• Manage stability protocol configurations and updates in LIMS
• Collaborate with the vendor on on-going system issues, upgrades, and maintenance

Associate Director, QC Data and Materials Management

Complex Claims Director, Excess

Complex Claims Director, Excess

Director, Infrastructure

Associate Director – Technology Transfer

Senior Associate Director, Programs – Laboratory Focus