Immunovant · 1 month ago
Director, GCP Auditing
United States
Full-time
Remote
Director/Executive
$215K/yr - $225K/yr
10+ years expImmunovant, Inc. is a clinical-stage immunology company focused on developing innovative therapies for autoimmune diseases. The Director of GCP Auditing will be responsible for planning and executing the GCP audit program, ensuring compliance with regulatory standards across clinical trials and related operations.
BiopharmaBiotechnologyPharmaceutical
Hiring Manager
Mohammad Ouranus
Responsibilities
Plan, organize, and conduct clinical audits as Lead Auditor to assess GCP compliance across various Clinical Investigator Sites and the company’s network of Clinical Research Organizations, Clinical Testing Laboratories, and Clinical Data Management Systems
Conduct targeted /for-cause audits to support quality investigations, scientific misconduct and potential serious breach of GCP, supporting the functional teams with identifying root cause and possible corrective/preventative actions
Collaborate with both internal and external parties to ensure audits are purpose-driven, refining audit scope as needed
Independently write-up audit reports, document and communicate findings across impacted functions within the organization
Collaborate with Clinical Quality on the preparation of study-specific risk profiles, evaluation of risks and controls related to GCP and study-specific requirements for various Clinical Investigator Sites
Maintain the Clinical Quality Audit Plan in collaboration with Clinical Quality to ensure GCP audits are effectively planned and executed in accordance with risk-based criteria
Manage and track audit and inspection observations
Track and maintain audit data /metrics using internal tools and systems
Support GCP inspection readiness activities
Serve as a resource for GCP compliance issues, offering guidance, identifying risks, and recommending mitigation strategies to stakeholders and functional teams
Escalate risks to senior management and suggest immediate and long-term solutions
Qualification
Required
Bachelor's degree (scientific or healthcare discipline preferred)
10+ years in a GxP pharmaceutical/biotech industry environment with strong practical application of GCP, solid knowledge of FDA, MHRA and EMA regulations and ICH requirements, experience with other GxP areas an advantage
8+ years of direct auditing experience as a Lead Auditor
Experience with managing external Consultants
Excellent communication skills, with the ability to remain objective and impartial throughout audits, findings presentations and implementation of CAPAs
Ability to independently interpret and apply practical knowledge of regulations and guidelines for the immediate resolution of compliance
Culturally competent to communicate and effectively navigate cross-functional needs within multiple teams
Ability to travel both domestically and internationally
Preferred
Lead Auditor Certification
Benefits
Full range of medical
Dental
Vision
401k
Unlimited paid time off
Parental leave
Company
Immunovant
Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.86BKey Investors
Roivant Sciences
2025-12-11Post Ipo Equity· $550M
2025-01-13Post Ipo Equity· $450M
2023-09-27Post Ipo Equity· $450M
Leadership Team
Melanie Gloria
Chief Operating Officer
Recent News
2026-01-11
MarketScreener
2026-01-05
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