Senior Manager, QC

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.Organizational Overview: Immunovant is a publicly traded, clinical stage biopharmaceutical company committed to developing innovative therapies for patients living with autoimmune diseases. We are developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of multiple autoimmune diseases that are mediated by pathogenic IgG antibodies.  The Role:  Immunovant is seeking a Senior Scientist, QC to provide quality oversight of Quality Control laboratory activities. The position directly reports to the Senior Quality Control / Director with responsibility for leading all Quality Control activities related to product analytical testing, while ensuring compliance with global GxP regulations across multiple indications. This individual will have the unique opportunity to help grow and shape IMVT Quality, while establishing a compliant and collaborative partnership with Analytical Sciences and contracted Quality Control laboratories. The Senior Scientist, QC is responsible for managing quality control activities and will provide leadership and oversight of GMP testing at CMOs and contract testing laboratories. The individual should be knowledgeable in multiple analytical techniques pertaining to proteins and/or mAbs separations. This role involves significant vendor oversight, primary raw data review, exceptions management (deviations, CAPAs, OOS/OOT), and change control, so requires a strong knowledge and understanding of GMP-regulated quality systems as it pertains to both internal systems and external organizations. This individual will work closely with other areas such as CMC Manufacturing, Quality Assurance, and CMC Regulatory Affairs to manage the manage key deliverables as it pertains to testing laboratories to ensure timelines coincide schedules and corporate goals. This individual will help ensure regulatory compliance with FDA, EMA, ROW, and other applicable global health authority requirements, as it pertains to laboratory testing activities. The Senior Scientist, QC will also participate in strategic planning with a focus on meeting corporate quality goals, promoting a culture of quality across the company, and ensuring a compliant culture of quality through effective management with strong adherence to Immunovant’s key value pillars. The individual is knowledgeable regarding regulations, industry guidance’s, and global quality systems for analytical testing. Key Responsibilities: Oversee GMP testing at CMOs/ third party testing sites as it applies to Quality Control testing of raw materials, components, in-process, and drug substance. Verify/review analytical source data to ens...