Quality Systems & OPEX Manager

TITLE:

Title: Quality Systems & OPEX Manager

Reports To: Head, Quality Systems & OPEX

Location: Richmond, VA

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” at Indivior. This 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 existing employees, as needed.

· Participate in key regulatory inspections and readiness efforts internally and externally as required.

· Any other duties as determined by management to support the Quality Systems and OPEX team.

MINIMUM QUALIFICATIONS:

License/Certifications: N/A

Travel: minimum 10%

· Bachelor of Science degree in a relevant scientific discipline from an accredited university required.

· Proven track record, minimum eight (8) years of quality experience, in a regulated industry such as FDA regulated, pharmaceutical or medical device.

· Broad knowledge of current GMPs, regulatory requirements related to international standards including GAMP5, EU, Health Canada, TGA, ICH, PIC/S.

· Knowledge of sterile manufacturing.

· Proficient in validation and qualification, risk assessments for equipment, facility and process.

· Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks. Make and communicate appropriate judgments on any assessed risks to continue or suspend until risk can be mitigated.

· Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action.

· Excellent communication skills - presentation, written and oral.

· Proven ability to work under pressure without compromising deliverables.

· Collects, understands, interprets and trends data on the quality system performance.

· Advanced computer skills including Microsoft platform and Visio.

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:

· Proficiency in conducting Risk Assessments to support deviation investigations, change management and CAPA.

· Highly skilled at training and coaching others in problem solving, root cause analysis and execution of improvements.

· Advanced working knowledge of the electronic Quality systems used at INDIVIOR is an advantage (e.g. Veeva, SAP, Success Factors).

· Excellent team player, able to work across boundaries to accomplish goals set.

· Excellent interpersonal and communication skills and ability to communicate clearly to peers and senior management.

· Influencing skills in areas with no direct reporting authority including senior management.

· Logical, process-based thinking necessary to work effectively in role.

· Able to understand different perspectives and deliver the best outcome for the global business.

· Global role that works across all functions where there is GxP responsibility. Expected to travel to meet the needs of the role.

· Green Belt certified in Lean Six-Sigma preferred.