Director, Clinical Supply, CMC QA

Summary

Join Immunovant, Inc., a clinical-stage immunology company, as a Quality Assurance Manager responsible for designing and implementing a robust quality assurance system for the clinical supply chain. Reporting to the VP, CMC and Distribution QA, you will identify and evaluate compliance risks, develop efficient GXP procedures, and collaborate cross-functionally to ensure compliant release and distribution of investigational products. This role requires driving continuous improvement, authoring technical documentation, and working with CMC & Clinical Operations to monitor investigational product post-release. You will also partner cross-functionally to establish regulatory surveillance, inspection readiness, and manage actions from internal and external audits. The position is remote-based with 10-20% domestic or international travel required. The salary range is $200,000-$215,000 USD, with additional equity and benefits.

Requirements

• BS/BA degree in a scientific or allied health field
• Minimum of 8+ years of hands-on experience in in the pharmaceutical industry
• Self-motivated nimble leader with extensive knowledge of cGMP/GCP regulations and requirements (ICH GCPs, EU GMPs, 21 CFR 211/600) and applicable global regulations for drug development
• Hands on expertise and advanced knowledge in the conduct and resolution of complex quality issues, root cause analysis, and the translation of findings into corrective action plans that mitigate risks to product quality, study subjects, data integrity, and study outcome
• Strong technical knowledge included but not limited to: vendor management, risk management, auditing techniques and quality governance
• Solid quality culture knowledge and understanding how to influence and improve overall compliance

Responsibilities

• Drive continuous improvement and ensure effective implementation and maintenance of systems at Immunovant in compliance with regulations and guidelines including: Notification to Management
• Drive continuous improvement and ensure effective implementation and maintenance of systems at Immunovant in compliance with regulations and guidelines including: IRT post-release issue resolution
• Drive continuous improvement and ensure effective implementation and maintenance of systems at Immunovant in compliance with regulations and guidelines including: Unblinding event investigation
• Drive continuous improvement and ensure effective implementation and maintenance of systems at Immunovant in compliance with regulations and guidelines including: Expiry extension re-labeling
• Drive continuous improvement and ensure effective implementation and maintenance of systems at Immunovant in compliance with regulations and guidelines including: Product stock recovery (clinical recalls)
• Serve as a quality point of contact and contributor in authoring and revising technical documentation including but not limited to: Standard Operating Procedures, Pharmacy Manuals, Risk Assessments,, Quality Agreements templates and tracking, IRT Systems Configuration and IRT Use Requirements Specifications
• Work closely with CMC & Clinical Operations functions to build/improve appropriate controls and apply best practices to monitor investigational product post-release through handling at clinical trial sites, including evaluation of temperature excursions, product complaints and support Just In Time labeling for study start up and resupply
• Partner cross-functionally to establish regulatory surveillance that results in appropriate timely compliance actions
• Partner cross-functionally to establish Inspection Readiness and Management processes and procedures
• Partner with the Sr. Director of Audit to drive actions resulting from internal and external audits

Preferred Qualifications

Advanced degree

Benefits

• Full range of medical, dental, vision
• 401k
• Other benefits
• Unlimited paid time off
• Parental leave
• Equity