Program Manager (AVI Lines Operational Readiness)

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

The Program Manager – AVI Lines Operational Readiness is a senior delivery role providing leadership and execution oversight for Operational Readiness activities associated with the AVI inspection lines SI02 and SI03 through qualification and Performance Qualification. The role operates within an established and experienced project environment and is accountable for ensuring readiness activities are planned, integrated, governed, and executed to support successful transition to routine operations. This role will lead and coordinate Operational Readiness execution for AVI inspection lines SI02 and SI03 through PQ, ensuring people, process, systems, documentation are prepared to support qualification and operational handover. The role ensures readiness activities are integrated with project execution and qualification plans while maintaining compliance, governance, and delivery discipline.

Duties:

• Own the Operational Readiness strategy and execution for AVI inspection lines SI02 and SI03 through qualification and PQ.
• Integrate readiness activities with capital project execution, commissioning, and validation milestones.
• Provide programme level oversight of readiness workstreams including documentation, training, change control, validation interfaces, MES readiness, and operational handover.
• Act as the primary Operational Readiness interface between Capital Projects and Operations for the AVI scope.
• Maintain integrated readiness plans, trackers, and dashboards aligned with company’s master schedule.
• Identify readiness risks, gaps, and dependencies and drive mitigation through governance.
• Provide clear readiness input to programme and senior leadership governance forums.
• Promote a strong safety culture across readiness execution.
• Ensure all Operational Readiness activities conform to cGMP requirements.
• Ensure scope and financial discipline in line with site governance.
• Support inspection readiness and regulatory interactions as required.

• Technical degree or equivalent experience in Engineering, Science, or Operations.
• 5 to 8 years’ experience in Pharmaceutical, Biotechnology, or Life Sciences manufacturing.
• Experience supporting Operational Readiness, capital project delivery, or qualification activities.
• Experience operating within GMP regulated environments
• Strong programme and project management capability within a GMP manufacturing environment.
• Experience coordinating complex cross functional delivery teams.
• Strong execution focus with structured planning and tracking discipline.
• Systems experience: Change Control & Document Management Systems, SharePoint and Microsoft 365 collaboration tools or Smartsheet equivalent programme tracking tools.