Director – GCP Auditing Lead

October 15

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Immunovant

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Immunovant is a company focused on advancing treatments for autoimmune diseases through a patient-focused approach. With a vision of enabling normal lives for people with autoimmune diseases, Immunovant applies its expertise in science to develop and test new therapies. The company emphasizes complex and variable needs across different stages and severities of diseases. Immunovant is committed to pushing forward its therapeutic areas and clinical trials, while also engaging with patients, caregivers, and investors about their ongoing studies and corporate initiatives.

51 - 200 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Reporting to Sr. Director, Quality Audit Management, ensure compliance with internal and external regulatory and quality standards • Plan, implement, execute and complete the GCP audit program using a risk-based approach for all Immunovant clinical trials • Conduct audits of Clinical Investigator Sites, CROs, Clinical Testing Laboratories, Clinical Data Systems and internal processes • Track audit metrics/data and monitor timelines to demonstrate effective execution of the GCP audit program • Independently write-up audit reports, document and communicate findings across impacted functions • Collaborate with Clinical Quality on the preparation of study-specific risk profiles

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

🏖️ Benefits

• full range of medical, dental, vision, 401k, and other benefits • unlimited paid time off • parental leave