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.
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