Senior Manager CMC Quality Assurance

Organizational Overview:

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.

The Role:

Reporting to the Director, CMC Quality Assurance, this position is responsible for performing the primary Quality review of all post- manufacturing-related documentation for a large molecule - drug substance and sterile drug product. The CMC Quality Sr. Manager will be responsible for implementing processes for document receipt from contract manufacturing organization, batch packet assembly and transfer to internal Immunovant collaboration, quality review of manufacturing documents, and final submission into the electronic records retention system in compliance with global GxP regulations. This individual will have the unique opportunity to help design and shape IMVT Quality processes while collaborating with external contract organizations to establish compliant, efficient, measured, and integrated batch review processes at a rapidly growing biotechnology company.

The CMC Quality Sr. Manager assembles and performs a technical quality review of executed manufacturing and testing documents provided by the contract manufacturer and laboratories to ensure regulatory compliance with FDA, EMA, ROW and other applicable global health authority requirements that ultimately ensure patient safety. The CMC Quality Sr. Manager then will liaise with the Immunovant CMC Team and collaborate with the CMO Quality Unit to ensure prompt and thorough resolution to any open matters identified in the technical review.

This position will contribute to Immunovant's success by managing IMVT's batch compilation and review activities under the primary QA Leads' guidance while working closely with applicable functional areas across Immunovant and in partnership with CMO Quality.

Key Responsibilities:

• Provide strategic planning input and continual improvement measures focused on records processes or document structure, reporting/escalating critical quality issues
• Conduct risk mitigation in the compilation of records and associated review activities, ensuring a compliant culture of quality through effective management with strong adherence to Immunovant’s key value pillars
• In close collaboration with the Quality and CMC, serve as a primary batch compilation lead and record point of contact for CMC and Quality, ensuring overall control and compliance, effectiveness, and efficiency of the Batch Compilation and Review Process
• Partner with QA Document Control and Records Retention to define, develop, and document processes related to the assembly of the batch records in the eDMS system
• Manage, maintain, and continuously improve the batch record review process as a facilitator for Quality Assurance in product teams
• Identify, develop, and implement key performance metrics associated with the post-manufacture assembly of records, including CMO performance metrics relating to Quality and error reduction. 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 by Director, CMC Quality Assurance

Requirements:

• Bachelor (B.S.) or advanced degree in Biology, Chemistry, Immunology or related fields
• A minimum of 5-8 years of GMP-regulated experience working within GMP Quality systems; in roles of increasing responsibility; substantial Drug Substance and Drug Product, clinical & commercial experience in GMP environment preferred
• Experience interacting with FDA, EMA, and other global health authorities
• Strong analytical and organizational skills, with attention to detail
• Excellent written, verbal, listening, and interpersonal communication skills
• Ability to professionally interface with all levels (e.g., senior-level executives, staff, colleagues, external partners, consultants)
• Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment
• Ability to take initiative, prioritize and execute tasks with minimal direction or supervision, maintaining a high-level of confidentiality, integrity, and discretion at all times

Work Environment

• Remote location
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic and international travel may be required (up to 10%) including required quarterly onsite meeting

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