EBR Program Manager

2 days ago

Mayo, Ireland TEAM HORIZON Full time

Team Horizon is seeking a eBR Program Manager for a pharmaceutical client in their Mayo site. The eBR Program Manager will provide technical support and leadership to a cross functional team responsible for the implementation of electronic batch record (eBR) and review by exception (RBE) over a 2-year period at the Westport site. They will develop and manage a detailed project plan for all aspects of the program and will apply best practice Program Management tools and methodologies to ensure the project phases are delivered on schedule and right first time. Why you should apply: This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve peoples lives. Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally. What you will be doing: Povide technical support and leadership to a cross functional team responsible for the implementation of electronic batch record (eBR) and review by exception (RBE) over a 2-year period at the Westport site. Lead the Change Management activity including cross functional requirements gathering, business process design and architecture, system validation, and consensus building towards an end to end, integrated systems environment which meets the requirements of the Quality System. They will develop and manage a detailed project plan for all aspects of the program and will apply best practice Program Management tools and methodologies to ensure the project phases are delivered on schedule and right first time. Strategically aware of other Digital Transformation initiatives throughout the company and be able to identify potential sources of funding or resources, for functionality that supports the eBR rollout and/or future Digital programs. Operate in an environment which is largely self-managed but with oversight from the Director, Digital Transformation.. Responsibilities: Evaluate activities, timelines and resource requirements necessary for the development and deployment of eBR/RBE Develop and maintain detailed program tracking tools and hold cross-functional matrix team to account for delivery of milestones across the 2 year program Ensure compliance with all necessary Quality and IT policies and procedures. Define and document the systems validation process with input and agreement from the Global systems owners Track the Financial costs of the program. Create a process to measure and track financial savings resulting from the project. Create a model to predict full life cost/benefit. Provide timely and accurate updates to Director Digital Transformation, Site Leadership Team and ME&C management regarding project planning and execution. No Direct Reports but will manage multiple cross functional resources including external contractors. Provides cross training and guidance on project management Contributes significantly to the site Digital Transformation Strategy Adheres to and supports all EHS & E standards, procedures and policies. What you need to apply: Qualifications: A Bachelors Degree or higher in a Relevant Discipline (Technical Qualification in Engineering, Science, Technology is a distinct advantage) Formal qualification in Project Management would be advantageous, but not essential Job/Technical Skills Extensive experience (6+ years) in manufacturing, supply chain management, engineering, and/or process/product development. Experience in planning and executing projects. Experience in leading cross-functional teams. Experience in influencing peers in other organizations and senior management. Skills: ebr technical IT MES gmp SAP project management

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