Project Portfolio Lead (Biopharma)

Summary:

A Project Portfolio Lead is required for a biopharmaceutical company in Waterford. The successful candidate will join a team responsible for overseeing and delivering projects across the site.

Responsibilities:

• 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
• Raise, author, and manage change controls in accordance with Sanofi’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 required.

Qualifications & 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 cGMPs, GLP, etc.