Director, GCP Auditing

Role Summary

Director, GCP Auditing will plan, implement, execute and complete the GCP audit program for Immunovant clinical trials, ensuring compliance with regulatory and quality standards. Reports to the Sr. Director, Quality Audit Management and oversees audits of Clinical Investigator Sites, CROs, Clinical Testing Laboratories, Clinical Data Systems, and internal processes, with a focus on risk-based methodology and data-driven decision making.

Responsibilities

• Plan, organize, and conduct clinical audits as Lead Auditor to assess GCP compliance across Investigator Sites and networked partners and systems
• Conduct targeted/for-cause audits to support quality investigations and identify root causes with corrective/preventative actions
• Collaborate with internal and external parties to ensure audits are purpose-driven and scope refined as needed
• Independently write audit reports and communicate findings across impacted functions
• Collaborate on study-specific risk profiles, risks and controls related to GCP and site requirements
• Maintain the Clinical Quality Audit Plan to ensure audits are planned and executed per 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, guiding risk mitigation strategies
• Escalate risks to senior management and propose solutions

Qualifications

• Bachelor‚Äôs degree (scientific or healthcare discipline preferred)
• 10+ years in a GxP pharmaceutical/biotech environment with strong GCP experience and knowledge of FDA, MHRA, EMA regulations and ICH guidelines; experience with other GxP areas advantageous
• 8+ years of direct auditing experience as a Lead Auditor
• Experience managing external consultants
• Excellent communication skills, objective and impartial during audits, findings presentations and CAPA implementation
• Ability to interpret and apply regulations for immediate compliance resolution
• Culturally competent to navigate cross-functional needs
• Ability to travel domestically and internationally
• Lead Auditor Certification preferred

Education

• Bachelor‚Äôs degree (scientific or healthcare discipline preferred)

Additional Requirements

• Remote-based work arrangement
• Domestic or international travel required (10-30%)