Responsibilities
Lead cross-functional, multi-site teams in the introduction and business integration of new products.
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 mitigation's 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
Raise, author, and manage change controls in accordance with 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.
Requirements / Qualifications
Experience in the biopharma industry, in a project leadership role.
Degree in Science, Engineering or equivalent.
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.
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