Associate Director, CMC Quality Assurance

Immunovant

Associate Director, CMC Quality Assurance ensuring quality compliance in drug manufacturing at Immunovant. Overseeing quality assurance activities and regulatory compliance to support sterile drug product manufacture.

Posted 7/9/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $175,000 - $195,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Good Manufacturing Practices (GMP) and Quality Assurance (QA) for sterile drug product manufacturing, ensuring compliance with regulatory requirements and effective oversight of quality systems. Proven ability to lead health authority inspection readiness and manage regulatory filings.

Highest-signal resume keywords

GMP ExperienceQuality Assurance ManagementRegulatory ComplianceSterile Drug Product ManufacturingCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Good Manufacturing PracticesQuality AssuranceRegulatory FilingsProcess Control StrategyData IntegrityBatch DispositionSOP DevelopmentQuality Management SystemsClinical Trials OversightOperational Efficiency

Soft Skills

Strong Communication Skills

Tools & Technologies

EQMSDocument Control Systems

Industry Keywords

FDA InteractionHealth Authority AuditsCombination ProductsBiologicsClinical Distribution Processes

About the role

Key responsibilities & impact

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

What you’ll need

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.

Benefits

Comp & perks

Equity and other forms of compensation may be provided as part of a total compensation package
full range of medical, dental, vision, 401k, and other benefits
unlimited paid time off
parental leave