Director, GCP Auditing Lead

Reporting to Sr. Director, Quality Audit Management, this position is vital for ensuring Immunovant’s clinical studies and operations are compliant with internal and external regulatory and quality standards.

The person in this role will plan, implement, execute and complete the GCP audit program using a risk -based approach for all Immunovant clinical trials, including audits of Clinical Investigator Sites, Clinical Research Organizations (CROs), Clinical Testing Laboratories, Clinical Data Systems and internal processes to ensure Sponsor oversight complies with Good Clinical Practice (GCP). They will also be responsible for tracking audit metrics /data and monitoring timelines to demonstrate effective execution of the GCP audit program and to support data-driven decision making.

• 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

Requirements:

• 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 and
• Culturally competent to communicate and effectively navigate cross-functional needs within multiple teams
• Ability to travel both domestically and internationally
• Lead Auditor Certification preferred

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required (10-30%)