Director, Clinical Supply, CMC QA @IMVT Corporation

[Hiring] Director, Clinical Supply, CMC QA @IMVT Corporation

Mar 27, 2025 - IMVT Corporation is hiring a remote Director, Clinical Supply, CMC QA. 💸 Salary: $200,000 - $215,000 usd. 📍Location: USA.

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Role Description

This position is responsible for designing and implementing an effective, robust quality assurance system for support of the Clinical supply chain through partnerships internally and externally. This position will identify and evaluate compliance risks and contribute to the development of streamlined and efficient GXP procedures and processes as they relate to Immunovant clinical supply chain.

This position will collaborate cross functionally to ensure compliant release and distribution of investigational products for multiple global clinical studies/programs leading to product approvals.

Drive continuous improvement and ensure effective implementation and maintenance of systems at Immunovant in compliance with regulations and guidelines including:

Notification to Management
IRT post-release issue resolution
Unblinding event investigation
Expiry extension re-labeling
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

Qualifications

BS/BA degree in a scientific or allied health field; advanced degree preferred
A minimum of 8+ years of hands-on experience 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

Requirements

Remote-based work environment
Dynamic, interactive, fast-paced, and entrepreneurial environment
Domestic or international travel are required (10-20%)

Benefits

Salary range for posting: $200,000 — $215,000 USD
Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience
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 and parental leave

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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Director, Clinical Supply, CMC QA @IMVT Corporation

Salary 💸 $200,000 - $215,000 usd	Remote Location USA
Job Type unspecified	Posted Mar 27, 2025

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[Hiring] Director, Clinical Supply, CMC QA @IMVT Corporation

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