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 statements
* Work 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 submission
* Project 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.