Senior Director, Clinical Quality Assurance (CQA)

May 24

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Logo of Immunovant

Immunovant

Dedicated to enabling normal lives for people with autoimmune diseases

Biotechnology Research

51 - 200

Description

• Immunovant is seeking a Senior Director, Clinical Quality Assurance (CQA) to serve as a key leader in Quality on a highly dynamic, cross-functional team • Provides global GCP oversight and direction for Immunovant Clinical Operations to ensure regulatory compliance with FDA, EMA, and other applicable global health authority requirements

Requirements

• Bachelor or Master’s degree in Biology, Chemistry, Nursing, or related fields • A minimum of eight (8) years of GCP experience with a focus on quality with substantial operational and clinical quality assurance experience • 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 • Experience interacting with FDA, EMA, and other global health authorities • Experience with building a GCxP culture in a start-up biotechnology company preferred throughout a company • Experience in immunology with clinical trials is strongly preferred

Benefits

• Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave.

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