Senior QA Validation Lead – Pharma Compliance

Regeneron Ireland; Limerick; On-site; EUR 54,000 - 88,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, -

Job summary

Regeneron Ireland in Raheen, Limerick is seeking a Senior QA Validation Specialist to join our Quality Assurance team. You will lead end-to-end qualification activities and support a 365 inspection readiness program.

The role requires 5–8+ years in pharma/biotech, strong change controls, data integrity awareness, and knowledge of EU Annex 11 and FDA 21 CFR Part 11. You will mentor staff and collaborate across departments to maintain regulatory compliance.

Qualifications

• BS/BA in Engineering, Chemistry or Life Science and 5–8+ years’ proven experience in the field preferred.
• SME experience in a highly regulated environment (pharma/biotech/medical devices) in audits.
• Strong background in site change controls, risk management and data integrity initiatives.

Responsibilities

• Supervising end‑to‑end qualification processes to ensure equipment fits for intended use.
• Fostering and implementing quality culture and manufacturing standards.
• Scheduling, executing, reviewing and approving qualification activities.
• Assessing change controls and deviations for regulatory impact.
• Investigating problems and proposing improvements.
• Reviewing deviation notifications, investigations, and corrective actions.
• Coordinating with departments and contractors to complete validation tasks.
• Managing and driving projects and mentoring staff.
• Communicating clearly and meeting scope/delivery commitments.
• Demonstrating knowledge of Data Integrity and project balancing.

Skills

QA validation

Regulatory compliance

Change control

Data integrity

Project management

Team leadership

GxP knowledge

Education

BS/BA in Engineering, Chemistry or Life Science

Job description

Regeneron Ireland in Raheen, Limerick is seeking a Senior QA Validation Specialist to join our Quality Assurance team. You will lead end-to-end qualification activities and support a 365 inspection readiness program.

The role requires 5–8+ years in pharma/biotech, strong change controls, data integrity awareness, and knowledge of EU Annex 11 and FDA 21 CFR Part 11. You will mentor staff and collaborate across departments to maintain regulatory compliance.