Director, GCP Auditing

@ Immunovant

Overview

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Role

Reporting to the Sr. Director, Quality Audit Management, the Director, GCP Auditing is vital for ensuring Immunovant’s clinical studies and operations are compliant with internal and external regulatory and quality standards. The role involves planning, implementing, executing, and completing the GCP audit program using a risk-based approach across all clinical trials including audits of Clinical Investigator Sites, CROs, Clinical Testing Laboratories, Clinical Data Systems, and internal processes to maintain sponsor oversight in line with Good Clinical Practice (GCP).

Key Responsibilities

• Plan, organize, and conduct clinical audits as Lead Auditor to assess GCP compliance across Clinical Investigator Sites and associated networks.
• Conduct targeted/for-cause audits to support quality investigations and identify root causes with corrective/preventative actions.
• Collaborate with internal and external parties to refine audit scope and ensure audits are purpose-driven.
• Independently write-up audit reports, document findings, and communicate them effectively across functions.
• Support preparation of study-specific risk profiles, evaluation of risks and controls for various sites.
• Maintain and manage the Clinical Quality Audit Plan in line with risk-based criteria.
• Track and manage audit data/metrics using internal tools and systems.
• Support GCP inspection readiness initiatives.
• Act as a resource on GCP compliance issues, offering guidance and recommending mitigation strategies.
• Escalate risks to senior management with both immediate and long-term solutions.

Requirements

• Bachelor’s degree in a scientific or healthcare discipline (preferred).
• 10+ years in a GxP pharmaceutical/biotech environment with strong practical GCP application.
• 8+ years of direct auditing experience as a Lead Auditor.
• Experience in managing external Consultants.
• Excellent communication skills and ability to remain objective.
• Ability to apply practical knowledge of regulations for immediate compliance resolutions.
• Culturally competent with effective cross-functional communication skills.
• Willingness to travel domestically and internationally.
• Lead Auditor Certification preferred.

Work Environment & Compensation

This is a remote-based position in a dynamic, interactive, fast-paced, entrepreneurial environment. Domestic or international travel (10-30%) is required. Salary range is between $215,000 - $225,000 USD with benefits including full medical package, dental, vision, 401k, unlimited paid time off, and parental leave. Equity and additional compensation forms may also be provided.

Key skills/competency

• GCP
• Audit
• Compliance
• Risk Management
• Pharmaceutical
• Regulatory
• Clinical Trials
• Quality Assurance
• FDA
• Lead Auditor