IT Compliance Lead

TITLE:

IT Compliance Lead

Title: IT Compliance Lead

Reports To: Director, SAP & Compliance

Location: Richmond, VA or Raleigh, NC

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 www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior. 

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.

ESSENTIAL FUNCTIONS:

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

IT Compliance Governance:

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

Team and Project Leadership:

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

Procedures and Controls

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

System Implementation and Validation Support:

• Provide CSV and system implementation expertise to the Business Units and IT functions. This includes consideration of, and compliance with applicable:

  International Pharmaceutical industry regulations and guidance

  INDIVIOR Global / Local policies, procedures and standards

• 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 (to agreed time and quality standards) from project teams of key documentation that is required 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.
• Iden