Associate Director, CMC Quality Assurance

About the Company

Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazers in FcRn inhibitor technology, the Company is boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs.

Responsibilities

• Provide technical leadership in support of activities governed by global GMP regulations
• Provide independent oversight and compliance direction for CMC Quality and product disposition, including CDMOs, CMOs, and Packaging Facilities
• Approve Protocols, Reports, Master Batch Records, and Executed Batch Records for Drug Product manufacturing
• Support development and implementation of Process Control Strategy
• Review and verify process data to assure compliance with data integrity and traceability requirements
• Disposition batches for human use in Clinical Trials
• Support health authority inspection readiness and audits
• Assist in preparation and review of regulatory filings such as INDs and BLAs
• Assist with development and maintenance of internal manufacturing and operational SOPs
• Utilize GMP-regulated quality management systems (eQMS) for document control, change control, deviations, and CAPAs

Requirements

• Bachelor or master’s degree in Biology, Chemistry, Engineering, or related fields
• Minimum of five years of GMP experience with a focus on Quality Assurance
• Substantial operational experience in sterile drug product manufacture
• Minimum of two years managing sterile drug product facilities
• Experience interacting with FDA and global regulatory bodies
• Experience with pre-approval readiness (PAI) for commercial manufacturing
• Strong oral and written communication skills

Preferred Qualifications

• Experience in medical device, combination product, and commercial biologics
• Experience with clinical or commercial distribution processes