Project Manager (Biopharma)

Summary:Our client is a biopharmaceutical company based in Waterford, seeking a Project Manager who will be responsible for their Automated Visual Inspection implementation project.Responsibilities:Support the execution of mAbs and LYO Automated Visual Inspection PPQs, including preparation for regulatory submission. Lead cross-functional, multi-site teams, in the introduction and business integration of the project.Translate customer needs into defined, approved project scope statementsWork with functional managers to quantify resource requirements.Establish detailed project plans and drive execution of project tasks in line with agreed scope, schedule, and cost.Establish and execute a communication plan for the project and facilitate information flow between stakeholders and sites.Drive project risk identification, analysis, response, and implement & monitor mitigations to minimise impact to the project or wider business.Facilitate cost estimation to determine project budget and drive adherence to budget and forecast submissionProject Stakeholder Management to analyse stakeholder expectations and their impact on the project, and to develop appropriate management strategies for effectively engaging stakeholders in project decisions and execution.The project manager is responsible for some project GMP documents in line with Waterford site procedures.Qualifications & Experience:Degree in Science, Engineering or equivalent.Experience in biopharma industry, in a project leadership role.Demonstrated experience in project/program management in drug substance or drug product.Proven experience managing the full project life cycle within a GMP-regulated environment.Project Management certification, PMI, etc.Working knowledge of cGMP’s, GLP etc.