Orion Group Life Sciences are currently recruiting an eBR Program Manager on behalf of our Multinational Biopharmaceutical Client based in Mayo on an initial 12-Month contract with potential to extend.
Purpose
* 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 two-year period.
* This role will lead Change Management activities including cross-functional requirements gathering, business process design and architecture, system validation, and consensus building towards an end-to-end, integrated systems environment that meets Quality System requirements.
* The Program Manager will develop and manage a detailed project plan for all aspects of the program, applying best-practice program management tools and methodologies to ensure project phases are delivered on schedule and right the first time.
* The individual will maintain strategic awareness of other Digital Transformation initiatives within the organization and identify potential sources of funding or resources that support the eBR rollout and/or future digital programs.
* This role will operate in a largely self-managed environment, with oversight from the Director of Digital Transformation.
Key Responsibilities
* Evaluate activities, timelines, and resource requirements necessary for the development and deployment of eBR/RBE.
* Develop and maintain detailed program tracking tools; hold cross-functional matrix teams accountable for milestone delivery over the two-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 global systems owners.
* Track the financial costs of the program.
* Create a process to measure and track financial savings resulting from the project, including a model to predict full life cycle cost/benefit.
* Provide timely and accurate updates to the Director of Digital Transformation, Site Leadership Team, and management regarding project planning and execution.
* Manage multiple cross-functional resources including external contractors (no direct reports).
* Provide cross-training and guidance on project management practices.
* Contribute significantly to the Digital Transformation Strategy.
* Adhere to and support all EHS & E standards, procedures, and policies.
Qualifications
* Bachelor’s degree or higher in a relevant discipline. A technical qualification in Engineering, Science, or Technology is a distinct advantage.
* Formal qualification in Project Management is advantageous but not essential.
Technical & Job Skills
* 6+ years of experience in manufacturing, supply chain management, engineering, and/or process/product development.
* Proven experience in planning and executing complex projects.
* Strong leadership experience with cross-functional teams.
* Demonstrated ability to influence peers and senior management across functions.
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