Director

• Provides analytical oversight and approval of cGMP documents (change controls, deviations, CAPAs, method qualification and validation protocols and reports, transfer protocols, justification of specifications, etc.)
• Implementation and life-cycle management of methods for testing raw materials, components, drug substance and drug product
• Analyze and interpret results and methods, troubleshoot processes and analytical methodologies, generate solutions to problems, and meet related regulatory requirements
• Author relevant CMC sections for regulatory submission documents
• Coordinate and/or participate in projects related to analytical responsibilities and propose improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies
• Work alongside analytical characterization (subject matter) expert and support protocol, data, and report review and finalization.
• Monitor and assess emerging Quality and Regulatory requirements/issues and determine impact to Immunovant; work to remediate any identified gaps
• Maintain an active analytical risk register compliant with current Quality Risk Management practices

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