Global Quality Systems Manager

7 hours ago

Slough, Slough, United Kingdom Indivior Full time
Job Title: Global Quality Systems Manager

Job Summary:

The Global Quality Systems Manager role is a key part of the global quality organization in helping to establish and drive a 'culture of quality' at Indivior. This is a tactical, hands-on role, reporting to the Head of Quality Systems & Operational Excellence (OPEX). The position will be responsible for the management, compliance, and improvement of specified elements of Indivior's Global Pharmaceutical Quality System.

Key Responsibilities:
  • Champion for the establishment and lifecycle management of the INDIVIOR Pharmaceutical Quality System (PQS).
  • Quality processes are effective, enabling commercial product release supporting patient's markets supplied globally.
  • Global role that works across all functions where there is GxP responsibility. Expected to travel to meet the needs of the role.
  • Continuous improvement methodology and deployment across the Supply & QA. This includes Lean Six-Sigma Methodologies and project management.
General Quality System & OPEX Responsibilities:
  • Working as part of the QS & OPEX team, ensure that the PQS is effectively designed, standardized, simplified, improved, and communicated to follow all applicable international regulations and standards, where product is manufactured and distributed.
  • Identify and report appropriate process & IT system metrics and trends to functional heads to drive compliance. Able to interpret metrics and trends and based on this, identify areas of improvement.
  • Act as process owners for your named processes (see section on specific accountabilities).
  • Provide direct oversight for the PQS processes (where the QS & OPEX does not have Process Ownership) and work with stakeholders to identify compliance gaps and identify improvements.
  • Escalate product and process quality issues and identified risks to the QLT and SLT teams as appropriate.
  • Ensure that the PQS Portal is maintained.
  • Participating in key regulatory inspections and readiness efforts internally and externally as needed.
  • Partner with GxP functions organization to implement improvements across the PQS.
  • Identification of improvements to the GxP processes based on root cause analysis, data-driven evidence, and use of appropriate Lean Six-Sigma methodology and tools.
  • Provide thought leadership and influence functional management to Champion OPEX within their functions.
  • Provide relevant information to the Heads of functions about the status of OPEX in their functions.
Global Training Process Owner:
  • Manage the process design and IT system to ensure compliance and engage the users.
  • Superuser supporting the use of the IT system, in conjunction with the IT function.
  • Engage partner groups in support of training matrices design and maintenance.
  • Determine, establish, and report appropriate metrics for GxP training, such that metrics drive compliance to the process.
  • Ensure that Supply/ QA curricula is relevant to the individual and accurate and system metric targets are being met.
  • Work with SLT & QLT to identify gaps in training and develop plans to mitigate.
  • Develop core GxP packages with SMEs and consultants (where necessary) and train out.
  • Act as a Supply consultant to enable development of better training packages such that they are tailored to the audience and contain the relevant technical details for the roles.
  • Lead (or support where needed) Global Employee Onboarding to GxP Systems.
Global Document Management Process Owner:
  • Manage the process and IT system to ensure compliance and engage the users.
  • Ensure that the SOPs and instruction documents are authored in accordance with best practice to be clear with regards to responsibilities, logical process flow, and training audience can be easily identified.
  • Ensure that SOPs and instruction documents and loaded into the correct area and maintain the continued compliance status for the system.
  • Superuser supporting the use of the IT system and business management.
  • Ensure training and access governance for document system is in place and maintained.
  • Authors and approver training is delivered to new users and refresher training delivered on a regular basis.
  • Ensure that the drafts, working, and final copies of SOPs, and other QA controlled documents are organized into electronic files and are easily retrievable when required and that these files have restricted access.
  • Manage the periodic review process for Commercial QA and Supply organization documents such as policies, SOPs, and other controlled documents.
  • DocuSign IT system business management and oversight, global Superuser.
  • Lead oversight for GxP record retention and archive processes globally.
Regulatory Intelligence:
  • Support the Process Owner to: Ensure that key changes in regulations and standards are effectively communicated and incorporated into the PQS for continual improvement. Align with Regulatory Affairs to leverage existing resources for the same efforts to maximize efforts and share information.
Requirements:
  • Bachelor of Science degree in a life science or engineering (preferred).
  • Experience in establishing quality processes and systems in the pharmaceutical, biopharma, or medical device industries.
  • Excellent working knowledge of CI tools and techniques.
  • Project Management experience or certification.
  • Green Belt Certified in Lean Six-Sigma.
  • Intermediate to advanced level of practical understanding of drug product/device regulatory requirements (e.g. EU GMP, WHO, PIC/S, CFR Part 4, CFR 21 Part 210/211/820).
  • Highly skilled at training and coaching others in problem-solving, root cause analysis, and execution of improvements.
  • In-depth working knowledge of the electronic Quality systems used at Indivior is an advantage (e.g. TrackWise, SuccessFactors, Veeva).
Competencies/Conduct:
  • Strong interpersonal and communication skills and ability to communicate clearly to peers and senior management is an advantage.
  • Able to deliver concise written or oral summaries to senior management.
  • Ability to deliver effective presentations and updates is an advantage.
  • Influencing skills in areas with no direct reporting authority.
  • Logical, process-based thinking necessary to work effectively in role.
  • Able to understand different perspectives and deliver the best outcome for the global business.
  • Strong planning and organization skills.
  • Must be able to identify effective cross-functional solutions through understanding of the business objectives, quality, cost implications, and organizational maturity.

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