Senior QA Specialist: Digital Manufacturing & Tech Transfer

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

Job summary

Regeneron Pharmaceuticals is seeking a Senior QA Specialist to join the Quality Assurance team in Limerick. The role leads QA activities for technology transfer, drives digital quality initiatives, and partners with cross-functional teams to ensure compliant, efficient technology introductions.

The successful candidate will have 5+ years (BS/BA) or 4+ years (MS) in pharma, strong GMP knowledge, and a track record in validating digital systems and MES implementations.

Qualifications

• BS/BA in scientific discipline or MS with relevant pharmaceutical experience.

Responsibilities

• Lead QA activities for technology transfer projects, managing risk and quality requirements.
• Provide QA leadership for new manufacturing technologies, equipment and digital systems.
• Collaborate with Manufacturing, IT, Validation, and other teams to support projects.
• Facilitate governance, risk assessment, and quality decisions for tech programs.
• Drive data-driven quality improvements and digitalization to boost performance.
• Support MES, electronic batch records, automation, and data integration.
• Identify opportunities to simplify processes and automate where compliant.
• Develop quality strategies, procedures, training materials, and governance.
• Monitor progress, risks, and KPIs for technology transfer and transformation.

Skills

Quality Assurance

Technology Transfer

GxP Compliance

Risk Management

Digitalization

Cross-functional Collaboration

Education

BS/BA in scientific discipline

MS in scientific discipline

Tools

MES

Electronic Batch Records

Automation Platforms

Data Historians

System Integrations

Job description

Regeneron Pharmaceuticals is seeking a Senior QA Specialist to join the Quality Assurance team in Limerick. The role leads QA activities for technology transfer, drives digital quality initiatives, and partners with cross-functional teams to ensure compliant, efficient technology introductions.

The successful candidate will have 5+ years (BS/BA) or 4+ years (MS) in pharma, strong GMP knowledge, and a track record in validating digital systems and MES implementations.