IT Compliance Lead

Overview

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category.

Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit  to learn more. Connect with Indivior on Linked In at

Title: IT Compliance Lead

Reports To: Director, SAP & Compliance

Location: Richmond, VA or Raleigh, NC

Position Summary

The IT Compliance Lead is a subject matter expert on computer systems validation (CSV) and is responsible for the development, maintenance and communication of global policies, procedures, best practice guidance and appropriate risk-based methodologies. This role partners with Business Units, IT teams, Quality, and Regulatory functions across multiple geographies to define computer system validation requirements and ensures IT project delivery, application management, change management and quality management solutions are managed in compliance with Pharmaceutical and Manufacturing industry regulations and department procedures.

The responsibilities of this role include, but are not limited to, the following:

• Determine strategy and roadmap for IT Compliance
• Mature IT Governance
• Keep abreast of IT Compliance trends and industry changes

• Partner with IT leadership and business functions on business initiatives
• Build strong and effective relationships with other IT teams to enable change initiatives
• Lead and support IT Compliance team members to improve technical abilities and career development

• Continue to mature IT related documentation
• Review and approve IT governance and procedure documents

• Provide CSV and system implementation expertise to the Business Units and IT functions, including consideration of applicable International Pharmaceutical industry regulations and guidance

• Develop and maintain global Policies, Procedures, Standards, Guidelines and Templates to support the validation of business solutions
• Develop, or oversee the preparation of, key validation deliverables (validation plans, validation reports, traceability matrices, etc.), gaining appropriate approvals from the Business Units, IT and Quality functions
• Manage the delivery of key documentation to support validation (specifications, installation & testing evidence, etc.), escalating where necessary to the project manager
• Develop, maintain, and execute training programs regarding Computer Systems Validation

Provide IT Governance oversight and / or coordination for the following areas:

• Coordinate IT risk reviews with the IT leadership team and relevant stakeholders
• Identify regulatory compliance risks and proactively work with the Business Units, IT, Quality and Regulatory to address these risks
• Provide compliance oversight to the IT change control process
• Ensure consistency across the IT Training program
• Provide administration, security and training support for systems utilized by IT compliance
• Monitor and continuously improve the IT and Sarbanes Oxley Act (SOX) controls

• Attend vendor audits as CSV and IT Compliance SME
• Help to coordinate the completion of audit questionnaires by IT vendors
• IT contact for internal, financial, and ITGC audits
• Provide expertise and be key IT contact to the Business Units and IT in preparing for, and responding to, regulatory inspections
• Perform periodic reviews of computer systems to evaluate and maintain compliance status

Education: 4-year Bachelor’s Degree

Field of Study: Scientific or technical discipline with focus on Information Technology or Bioscience

Industry: Pharmaceuticals / Life science

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