Immunovant

QA Engineer

• Provide quality oversight of laboratory activities for analytical testing and ensure compliance with global GxP regulations
• Provide leadership and oversight of GMP testing at CMOs and contract testing laboratories
• Vendor oversight, review and approval of method validation, method transfer and stability documents, primary raw data review, exceptions management (deviations, CAPAs, OOS/OOT), and change control
• Work closely with CMC Manufacturing, Quality Control, CMC QA, and CMC Regulatory Affairs to manage testing laboratory deliverables and timelines
• Ensure regulatory compliance with FDA, EMA, ROW, and other global health authority requirements related to laboratory testing
• Participate in strategic planning to meet corporate quality goals and promote a culture of quality across the company
• Participate in regulatory inspections and third-party audits as needed
• Review and approve sampling instructions, test methods, specifications, stability protocols, and QC procedures
• Drive product quality through virtual Quality systems, supplier oversight, surveillance and KPI collection

Senior Scientist, Laboratory QA

Director

• Provide statistical inputs into protocol and clinical study report development, statistical analysis plans, interpretation of statistical analysis results, randomization plans
• Provide oversight and review of statistical documents for multiple clinical trials, including TLF shells, eCRFs, specifications of variable derivations, and all deliverables from outside vendors or internal programmers
• Develop effective collaborations with others within clinical teams and partner lines (such as Statistical Programming, Data Management, Medical, Clinical Operations, and Regulatory)
• Ensure that all study level statistical activities are conducted in compliance with relevant regulatory requirements and Immunovant standards
• Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports
• Oversight statistics and programming vendors
• Open to opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making
• Remote-based; access to Immunovant’s NYC and North Carolina offices available
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel may be required (<10%)

Senior Scientist, Laboratory QA

Associate Director, Biostatistics