Associate Director, CMC Quality Assurance

Organizational Overview:

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.

The Role:

Immunovant is seeking an Associate Director, CMC Quality Assurance (QA) to play a key quality role in ensuring high quality/regulatory compliance during the cGMP manufacture of IMVT-1402, in strategic partnership with critical global service providers. The individual in this position will have the unique opportunity to help grow and shape the IMVT- 1402 Quality processes including those supporting sterile drug product manufacture and clinical packaging at a rapidly growing biotechnology company.

This position will contribute to Immunovant’s success by managing CMC QA activities under the guidance of the Sr. Director, CMC QA, while working closely with internal functions at Immunovant and external strategic manufacturing and testing vendors.

The Associate Director, CMC QA provides QA oversight and direction for Immunovant CMC Drug Product and Device Development operations to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate. In addition, this role provides partners both internally and externally to drive process continuous improvement and mitigation activities pertaining to manufacture and packaging of investigational materials for clinical trials while and ensuring a culture of quality and compliance through effective leadership and strong adherence to Immunovant core values.

Key Responsibilities:

• 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

Requirements:

• Bachelor or master’s degree in Biology, Chemistry, Engineering, or related fields
• A minimum of five (5) years of GMP experience with a focus on Quality Assurance (QA) with substantial operational experience in sterile drug product manufacture; in roles of increasing responsibility; a minimum of two (2) years managing sterile drug product/sterile drug product facilities;
• Strong communication skills: oral/written and listening
• Experience interacting with FDA and global regulatory bodies/health authorities; pre-approval readiness (PAI) for commercial manufacturing
• Experience in medical device, combination product and commercial biologics strongly preferred
• Experience with clinical or commercial distribution processes is a bonus.

Work Environment:

• Remote location
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic and international travel is required (up to 30%) including required quarterly onsite meetings