Senior QA Lead — Digitalized Tech Transfer

Regeneron; Limerick; On-site; EUR 54,200 - 88,400; Full time

Job summary

Regeneron, a science-driven biopharma company, is seeking a Senior QA Specialist to join the Quality Assurance team at Raheen, Limerick, Ireland. This on-site role focuses on QA activities for technology transfer, risk management, and the introduction of new manufacturing technologies and digital systems.

You will partner with Manufacturing, IT, Validation, and other stakeholders to support digitalization, MES, electronic batch records, and data integrity.

Qualifications

• BS/BA in scientific discipline and 5+ years (or MS with 4+ years) pharmaceutical experience.
• Specialist: 2 years experience in QA or related role.

Responsibilities

• Lead and support QA activities for technology transfer projects.
• Provide QA project leadership for new manufacturing technologies and computerized systems.
• Collaborate with Manufacturing, Engineering, IT, Validation, and Supply Chain for projects.
• Facilitate governance, risk assessments, and quality decisions for system implementations.
• Drive data-driven quality approaches to improve processes, visibility, and compliance.

Skills

Quality Assurance

Technology transfer

Regulatory compliance

GxP knowledge

Data integrity

Cross-functional collaboration

Education

BS/BA in scientific discipline

MS (4+ years)

Tools

MES

Electronic batch records

Validation principles

Job description

Regeneron, a science-driven biopharma company, is seeking a Senior QA Specialist to join the Quality Assurance team at Raheen, Limerick, Ireland. This on-site role focuses on QA activities for technology transfer, risk management, and the introduction of new manufacturing technologies and digital systems.

You will partner with Manufacturing, IT, Validation, and other stakeholders to support digitalization, MES, electronic batch records, and data integrity.