Senior QA Validation Lead – GMP Regulated Systems

BioSpace; Ireland (WV); On-site; USD 61,000 - 99,000; Full time

Job summary

Regeneron in Raheen, Limerick, is seeking a Senior QA Validation Specialist to join its Quality Assurance team. The role focuses on supervising end-to-end qualification processes for equipment used in QC analysis, ensuring readiness and compliance with regulatory expectations.

The ideal candidate has a BS/BA in Engineering, Chemistry or Life Science with 5–8+ years in a regulated environment, including SME exposure to audits.

Qualifications

• BS/BA in Engineering, Chemistry or Life Science is required.
• Minimum 5–8 years of proven QA validation experience in regulated environments.
• Strong knowledge of data integrity and regulatory expectations.
• Experience with change controls, deviations, investigations, and CAPA processes.

Responsibilities

• Supervise end-to-end qualification processes ensuring equipment fits for intended use.
• Foster a quality culture and enforce manufacturing standards, policies and SOPs.
• Schedule, execute, review and approve qualification activities.
• Assess change controls and deviations for conformance with specs and regulations.
• Investigate issues and propose root-cause, corrective actions and improvements.
• Review and approve deviation notifications, investigations, and change controls.
• Coordinate with other departments and external vendors to complete validation tasks.
• Manage and drive validation projects and mentor junior staff.

Skills

Quality Assurance

Regulatory audits SME

Data integrity

Project management

Education

BS/BA in Engineering, Chemistry or Life Science

Job description

Regeneron in Raheen, Limerick, is seeking a Senior QA Validation Specialist to join its Quality Assurance team. The role focuses on supervising end-to-end qualification processes for equipment used in QC analysis, ensuring readiness and compliance with regulatory expectations.

The ideal candidate has a BS/BA in Engineering, Chemistry or Life Science with 5–8+ years in a regulated environment, including SME exposure to audits.