To assure the Integrity of GxP data and to ensure that all aspects of GxP data management comply with regulatory and the related QMS requirements.
To assure the Information Privacy and Protection on internal systems and individuals follows the client’s Global requirements
Manage business reporting to identify business process improvements.
Participate on the execution of the Data Integrity Plan in line with the overall Quality Plan.
Participate on the execution and implementation of the IP&P policies and standards in vaccines
To provide subject matter expertise on Data Integrity, IP&P and related processes and practices in alignment with regulatory expectations.
Participate in the implementation of the Data Integrity Plan and IP&P Plan.
To promote the importance of Data Integrity and the IP&P to the Division.
To promote the concept of Data Integrity by Design to ensure that processes, equipment and facilities
are designed to promote data integrity.
Maintain GxP Data Integrity Education and Training Program and monitor its effectiveness.
Ensure that audit findings of global / structural relevance in the area of responsibility are addressed.
Promote the optimization and full use of quality data to effectively measure business performance, predict and prevent trends and identify risks and areas for improvement.
Information Protection and Privacy activity preparation, execution, consolidation, and communication
Promote and manage the database tool access to guaranty the assessment of all the Vaccines systems
Participate in the MidYear review and the next year workplan (Y.O.P)
Governance reporting and content preparation
Update required budgets and resources for execution of project in line with Development Strategy, ensure resource planning across all departments to deliver project plan.
Drive preparation of the DI Network and IP&P Board minutes
Drive the preparation of the Quality Council Primary and Secondary presentations
Proactively identify deviations from schedule and any other issues, evaluate options and implement
optimal solutions within a defined timeframe through appropriate interactions with team members
Drive preparation for key decisions at appropriate governing bodies and/or escalate to governing bodies as required.
Ensure identification of project risks and creation of risk register for the project, manage the register on an on-going basis.
Ensure relevant and timely communication around projects to relevant stakeholders, ensure that project planning information is accurate and up to date in corporate systems used to manage and report progress.
Proactively communicating key information of the project (e.g. Decisions, milestones, actions, etc…) to all relevant stakeholders and to ensure documentation and archiving of project governance.
Actively contribute to preparation of program and work streams reviews and provide data related to project as required.
Provide project management expertise and leadership that is consistently applied (including identification of management of critical path activities, timelines and associated budget), actively participate in initiatives around project management best practices and drive deployment of project management practices across Quality.
Subject Matter Expert in Data Management and Controls and Information Protection and Privacy focused on delivering Data Integrity
Technical expert of equipment mitigation and remediation.
Tagged as: Data Integrity SME/Technical Expert
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