Project Portfolio Lead

Role Summary:

• A new vacancy has arisen for a Project Portfolio Lead supporting our client’s Project Portfolio Management group based on their bio-pharmaceutical site in Co. Waterford.
• The Project Portfolio Management group provides oversight and delivers projects for the Waterford site and to the benefit of the patients and the company.
• We are looking for a Project Portfolio Lead, who challenges common thinking to get a better result, is an effective problem solver, and is a team player that helps others to join a team that always seeks what is best for their patients and customers.

Core Duties and Responsibilities:

Project Portfolio Lead for the following:

• Dupixent Drug Substance (DS) Transfers (Fuji Transfer)
• Twin Bag Project

Project management responsibilities to support the above projects will include:

• Lead cross-functional, multi-site teams in the introduction and business integration of Dupixent DS
• Translate customer and business needs into defined, approved project scope statements
• Work with functional managers to quantify resource requirements across the cluster
• Establish detailed project plans and drive execution of project tasks in line with agreed scope, schedule, and cost
• Run regular project meetings to lead and influence the project, adhere to scope, and ensure timely completion according to schedule; establish and execute a communication plan 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 budgets and drive adherence to budget and forecast submission
• Project Stakeholder Management — analyse stakeholder expectations and their impact on the project, and develop appropriate management strategies for effectively engaging stakeholders in project decisions and execution

Change Leadership & Change Control responsibilities will include:

• Raise, author, and manage change controls in accordance with the company’s Quality Management System (QMS) and site SOPs
• Coordinate and track the execution of change control tasks across cross-functional teams, ensuring timely completion of all actions
• Manage change control workflows ensuring compliance with GMP and regulatory requirements
• Conduct post-implementation reviews to confirm changes have been effectively executed and documented
• The Project Portfolio Lead is responsible for GMP documents in line with Waterford site procedures; therefore, training to Waterford GMP systems is require.

Minimum Qualifications and Experience:

• Degree in Science, Engineering or equivalent
• Experience in the biopharma industry, in a project leadership role
• Demonstrated experience in project/program management in drug substance or drug product
• Demonstrated experience in change control management within a GMP-regulated environment
• Working knowledge of cGMP, GLP, etc.