Facility Operational Readiness Associate Director

About the role

Join a state‑of‑the‑art vaccines manufacturing facility in Dundalk and play a pivotal role in preparing the site for product launch, process performance qualification, and commercial manufacturing. As the Facility Operational Readiness Associate Director, reporting to the Site Operational Readiness Lead, you will partner with department leads to coordinate and drive readiness activities across multiple functions.

Key responsibilities

• Support the delivery of operational readiness strategies and plans linked to successful manufacturing and product launch activities.
• Coordinate cross‑functional readiness activities across multiple workstreams, ensuring alignment of priorities, timelines, and dependencies.
• Facilitate governance forums, readiness reviews, action tracking, and escalation processes to support effective decision‑making.
• Partner with functional leaders to ensure readiness across quality systems, training, supply chain, manufacturing systems, facilities, and operational processes.
• Maintain visibility of programme risks, issues, and key milestones, helping teams resolve challenges before they impact delivery.
• Support the transition from commissioning and qualification activities through to operational readiness and routine manufacturing.
• Drive operational rehearsal activities, scenario planning, and contingency preparedness.
• Build strong relationships across site functions to enable collaboration and alignment.
• Support executive communications and reporting, providing clear insights on progress, risks, and priorities.
• Identify opportunities to improve readiness frameworks, governance processes, and ways of working while capturing lessons learned for future initiatives.

Required profile

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Business, Supply Chain, or a related discipline.
• Significant experience within the pharmaceutical, biotechnology, or vaccine manufacturing industry.
• Strong understanding of GMP manufacturing operations, quality systems, validation, regulatory compliance, and operational excellence principles.
• Experience supporting facility start‑up, operational readiness, technology transfer, process validation, PPQ, product launch, or commercial manufacturing activities.
• Proven track record of leading or coordinating complex cross‑functional programmes within a regulated manufacturing environment.
• Strong stakeholder management and influencing skills with the ability to build credibility across all organisational levels.
• Demonstrated ability to manage competing priorities, navigate ambiguity, and deliver results in a fast‑paced environment.
• Excellent communication, presentation, planning, and organisational skills.
• Experience preparing updates, recommendations, and risk assessments for senior leadership teams.

Required skills

• Good Manufacturing Practices (GMP)
• Operational Excellence
• Product Launches
• Technology Transfer
• Project Management
• Lean Six Sigma
• PMP
• PRINCE2