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.