Immunovant

Manager

• 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 ensure data integrity, traceability, and compliance during review of all analytical documentation required for the release of product.
• Ensure adequate phase-specific qualification and validation of analytical QC test methods in collaboration with Analytical Development, through oversight and collaboration, and data/document review of associated protocols/reports.
• Manage technology transfers and method improvements needed to ensure reliable, robust, fit for purpose, and cGMP compliant methods are implemented at the testing laboratories.
• Analyze and interpret results and methods, troubleshoot processes and analytical methodologies, generate solutions to problems, and meet related regulatory
• Provide analytical oversight, facilitation, and leadership for OOS investigations, change controls, deviations, CAPAs, risk assessments, and continuous improvement initiatives.
• Review and approve sampling instructions, test methods, specifications, stability protocols, and other Quality Control procedures.
• Drive product quality through effective virtual QC systems, provide supplier oversight with adequate surveillance.
• Assure all applicable laboratory quality processes are deployed within IMVT and maintained in accordance with GMP, policies, and procedures.
• Monitors and assesses emerging Quality and Regulatory requirements/issues and determines impact to Immunovant and works to remediate any identified gaps.
• Ensure contracted third-party testing laboratories follow appropriate quality and regulatory practices and participate in regulatory inspections and third-party audits, as needed.
• Encourage an environment for ‘Quality Right First Time’ by building in efficiencies as necessary from a systematic and compliance perspective.
• Perform additional Quality-related duties as assigned.

Senior Manager, QC

QA Engineer

• Provide strong technical leadership in support of activities governed by global Good Manufacturing Practices (GMPs) regulations and guidelines
• Provide independent oversight and compliance direction with authority for CMC Quality and product disposition, including CDMO’s, CMOs and Packaging Facilities
• Support process and product quality through effective CMC quality systems, ensuring adequate supplier oversight/surveillance
• Approve Protocol and Reports, Master Batch Records and Executed Batch Records for Drug Product manufacturing including sterile combination product filling and packaging
• Support development and implementation of Process Control Strategy
• Review and verify process data to assure compliance with data integrity and traceability regulatory requirements as appropriate
• Disposition batches for human use in Clinical Trials
• Support health authority inspection readiness activities for Immunovant and its partners ; support health authority audits by regulatory agencies
• Assist in preparation and review of regulatory filings and safety data (e.g., INDs, BLAs, Annual Reports) to ensure compliance with regulatory procedures
• Assist with development and maintenance of internal manufacturing and operational SOPs related to GxP activities, with primary focus on cGMP regulations and sterile material
• Ensure that all products manufactured meet the registration and cGMP requirements based on global regulatory requirements
• Support identifying and implementing efficiencies in the overall manufacturing process including process development activities, device development activities, and sterile drug product manufacturing (filling, labeling, packaging, and distribution)
• Utilize GMP-regulated quality management systems and eQMS, to complete document control, change control, deviations/complaints, DS/DP release and CAPAs
• Perform other quality-related responsibilities in support of the QLT as necessary

Associate Director, CMC Quality Assurance

Director

• Provide oversight and contributions to statistics strategy, planning, execution, and communication for programs as assigned.
• Provide scientifically rigorous statistical input into clinical development plans, protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives.
• Develop effective collaborations with others within clinical teams and partner lines (such as Medical Directors and Regulatory).
• Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Immunovant standards.
• Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making.
• Manage indication/study biostatisticians.

Senior Director, Biostatistics

Accounting Manager

• Prepare month-end clinical and R&D accrual analyses, including reviews of CRO reports, patient costs, site accruals, and clinical manufacturing accruals, while ensuring compliance with US GAAP and company policies.
• Prepare corresponding monthly journal entries and related supporting documentation.
• Prepare monthly accounts reconciliations (clinical and related prepaids/accrued expenses).
• Conduct variance analysis and provide insights into financial performance, highlighting key trends and potential risks.
• Review contracts and amendments to analyze/determine impact on clinical accruals.
• Maintain SOX controls for assigned areas of responsibility.
• Support the internal and external reporting requirements to ensure timely and accurate financial reports for management, investors, and regulatory compliance.
• Work cross functionally with Clinical Operations, Manufacturing, Research and FP&A and other various business owners.
• Work with external CROs and clinical/manufacturing vendors to ensure that accruals are accurately accounted for.
• Assist with providing necessary documentation and explanations related to R&D accounting for the annual audit to our external auditors.
• Possess a continuous improvement mindset, identifying opportunities to enhance accounting processes and systems.
• Provide support as needs arise for special projects, system improvements, or ad-hoc requests.

Senior Manager, R&D Accounting

• Author, maintain and implement study-specific Clinical Quality Audit Plan(s) for assigned clinical program(s) and trial(s) to ensure the execution of a phase-appropriate, fit-for-purpose Audit Program
• Represent Quality at cross-functional clinical program meetings and Clinical Study Team meetings and operational activities to provide appropriate Quality guidance on GCP compliance matters to internal departments.
• Identify, mitigate, or escalate clinical quality risks by leveraging GCP knowledge and best practices across all phases of clinical development.
• Maintain program oversight and influence proactive quality management through quality related activities with regard to vendor management, study conduct, and study
• Author and/or review QMS controlled documents which may include standard operating procedures (SOPs) in accordance with applicable regulatory requirements (e.g., ICH E6, FDA, EMA, MHRA, local regulations)
• Oversee the implementation of appropriate and timely Deviation, Investigations and
• Participate in risk review meetings and review study Risk Management
• Conduct QA reviews of essential documents including as applicable Clinical Protocols, Study Plans/Manuals, Investigator Brochures, Investigator’s Brochure, for ensuring quality, accuracy, and completeness
• Collaborate with internal and/or external stakeholders to ensure management of GCP quality issues, CAPAs, and change controls
• Identify process improvements to build compliance into the design and conduct of clinical activities
• Actively support the development and deployment of Inspection Readiness/Management program to support competent authority inspections for sponsor and clinical sites & vendors

Senior Manager, QC

Associate Director, CMC Quality Assurance

Senior Director, Biostatistics

Senior Manager, R&D Accounting

Director, Clinical Quality Assurance – CQA