Quality Systems & OPEX Manager

Quality Systems & OPEX Manager

Reports To: Head, Quality Systems & OPEX

Location: Richmond, VA

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 by visiting

POSITION SUMMARY:

The Global Quality Systems and Operational Excellence (OPEX) Manager role is a key part of the global quality organization in establishing and maintaining Quality Systems and driving a “culture of quality” s is a key role in creating strategic plans with cross functional stakeholders to improve compliance and reduce risk in the Pharmaceutical Quality System (PQS). This role’s focus will be to support the review and approval of all INDIVIOR GxP IT system change controls and validation documents, lead the product quality complaints process, and facilitate global Deviation and CAPA management to support the business.

ESSENTIAL FUNCTIONS:

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

• Cross-functional influence to create strategic plans to ensure establishment and lifecycle management of a compliant Pharmaceutical Quality System (PQS) which contains over 100 cross-functional processes.
• Oversee and action GxP IT systems change controls and validation documents such as quality assurance plans, test scripts and other documents as required; also supports technical transfer, testing, qualification and validation.
• Write, review and/or approve validation protocols and reports.
• Provides GxP IT support to INDIVIOR reviewing and approving IT change controls quality assurance plans and other validation records.
• Participates in 3rd party validation planning meetings and communicates key information to INDIVIOR stakeholders as related to IT systems.
• Lead the management and triage of product quality complaints.
• Identify and report appropriate process and IT system metrics and trends to functional heads to drive compliance. Ability to interpret metrics and trends and based on this, identify areas of improvement.
• Provide direct assistance to the Quality Operations teams for the resolution of quality events.
• Act as a process owner for Quality Management System processes.
• Act as IT system Superuser (if the process uses an IT system) and able to support and advise on IT system changes and carry out execution of test scripts when required.
• Ensures compliance and reduced Regulatory risk in the PQS.
• Ensures PQS processes are effective, enabling commercial product release supporting patient’s markets supplied globally.
• Provide direct oversight and influence for the PQS processes (where the Quality Systems team does not have Process Ownership) and work with stakeholders to identify and rectify compliance gaps and improvements.
• Utilize continuous improvement methodology and deployment across functions to improve processes. This includes Lean Six-Sigma methodologies and project management.
• Provide direct support for all related continuous improvement activities as applicable.
• Assist Indivior Head, Quality Validation and Validation Manager in providing support in IT change management and validation activities that may impact product and/or process.
• Assist in providing support for all GxP changes and additions to SOP, Work Instruction, specifications and like controlled documents.
• Monitor and improve the health and execution of owned process(es) through metrics (process & IT system metrics) and other appropriate control measures, update the documentation periodically or as the process changes and ensure the relevant people are adequately trained for their role in the process.
• Assist in providing training support for new and…