Validation Lead: Lead GMP Validation & Strategy

Biopharma Careers; Ireland; On-site; EUR 90,000 - 130,000; Full time

Job summary

Astellas is seeking a leader to guide the daily operations of the Validation function at our Tralee site in Ireland. You will manage Validation Engineers (staff and outsourced providers), drive efficiency, and ensure processes, systems, and equipment perform to the highest standards in a GMP environment.

Responsibilities include leading the Validation team, maintaining compliance with GMP/GDP, and contributing to global strategy while delivering strategic projects on time and within budget.

Qualifications

• Bachelor's degree in Engineering or a Scientific discipline is required.
• Proven leadership of validation teams and projects.
• Strong communication and cross-functional collaboration capabilities.

Responsibilities

• Lead and grow the Validation team, fostering a high‑performance culture.
• Ensure continuous supply and achievement of departmental objectives with KPI delivery.
• Maintain GMP, GDP, safety and data integrity; ensure audit readiness.
• Contribute to site/global strategy and timely execution of strategic projects.
• Lead deployment of new products, systems, and procedures with compliant change management.

Skills

Validation leadership

Cross-functional collaboration

Project management

Communication skills

Education

Bachelor's degree in Engineering or Scientific discipline

Job description

Astellas is seeking a leader to guide the daily operations of the Validation function at our Tralee site in Ireland. You will manage Validation Engineers (staff and outsourced providers), drive efficiency, and ensure processes, systems, and equipment perform to the highest standards in a GMP environment.

Responsibilities include leading the Validation team, maintaining compliance with GMP/GDP, and contributing to global strategy while delivering strategic projects on time and within budget.