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. Phase 2 clinical development is ongoing with Phase 3 preparations underway.

The Role:

Immunovant is seeking a Director, CMC Quality Assurance (QA) to play a key quality leadership role in ensuring high quality/regulatory compliance during the cGMP manufacture of IMVT-1401, in strategic partnership with critical global service providers (e.g. CDMO’s), while also supporting global CMC regulations across multiple indications in the IMVT-1401 program.  The individual in this position will have the unique opportunity to help grow and shape the IMVT-1401 Quality Leadership Team (QLT), evolving the company’s Quality Management System (QMS), and supporting CMC regulatory processes at a rapidly growing biotechnology company.

 

This position will contribute to Immunovant’s success by managing CMC QA activities under the guidance of the Vice President, Head of Quality, while working closely across internal functions at Immunovant and external partnerships with strategic vendors.

 

The Director, CMC QA provides QA oversight and direction for Immunovant CMC operations to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  In addition, the this role provides strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and ensures a culture of quality and compliance through effective leadership and strong adherence to Immunovant core values.

 

Key Responsibilities: 

 

  • Provide strong strategic leadership for CMC QA at Immunovant in support of Good Manufacturing Practices (GMPs) with significant operational and quality experience
  • Provide independent oversight and compliance direction with authority for CMC Quality and product disposition, including CDMO’s, CMOs and Packaging Facility

o   Drive process and product quality through effective virtual CMC quality systems, ensuring adequate supplier oversight/surveillance

o   Approve Protocol and Reports, Master Batch Records and Executed Batch Records at the CDMO and the CROs for Filling and Packaging

o   Ensure that all necessary steps are added to the Process Control Strategy

o   Review and verify process data to assure compliance with data integrity and traceability regulatory requirements as appropriate

o   Disposition (approve/reject) batches for release

  • Ensure that Immunovant and its partners are inspection-ready for health authority audits by regulatory agencies; lead engagements with health authorities
  • Assist in preparation and review of regulatory filings and safety data (e.g., INDs, BLAs, Annual Reports); ensure compliance with regulatory procedures
  • Oversee development and maintenance of internal manufacturing and operational SOPs related to GxP activities, with primary focus on cGMP regulations
  • Ensure that all products manufactured meet the registration and cGMP requirements based on global regulatory requirements.
  • Responsible for driving efficiencies and supporting the overall manufacturing process including process development activities, drug substance formulation and drug product manufacturing (filling, labeling, packaging, and distribution).
  • Utilize GMP-regulated quality management systems and eQMS, including document control, change control, deviations/complaints, DS/DP release and CAPAs.
  • Coordinate with other departments within Immunovant to establish a robust QMS
  • Develop strategic plans using a Quality Systems approach to accommodate department and Quality division growth and lead the clinical operations team toward successful implementation and execution of the systems
  • Provide direct oversight of activities related to participation in U.S. FDA (CBER) and other regulatory agency inspections
  • Train and mentor junior staff; provide company-wide training as needed
  • 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 eight (8) years of GxP leadership with a focus on Quality Assurance (QA) with substantial operational experience; cGMP expertise required
  • A minimum of five (5) years in roles of increasing management responsibility in a biopharmaceutical environment; a minimum of two (2) years managing Phase 1-3 clinical trials; commercial experience optimal
  • Strong communication skills:  oral/written and listening
  • Experience interacting with FDA and global regulatory bodies/health authorities; pre-approval readiness (PAI) for commercial manufacturing preferred
  • Experience with building a GxP culture throughout a company
  • Experience in commercial biologics and immunology are strongly preferred

 

Work Environment:

  • Preferred location is Immunovant’s NYC or Durham office; remote considered
  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • Domestic and international travel is required (up to 35%)
  • Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability

 

This position has been filled.