Senior QA Lead - Digital Transformation & Tech Transfer

Regeneron Pharmaceuticals, Inc; Munster; Vor Ort; EUR 54.200 - 88.400; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. in Raheen, Limerick is seeking a Senior QA Specialist to join the Quality Assurance team and drive quality across technology transfer projects.

You will lead QA activities for new manufacturing technologies, equipment, and digital systems, partnering with Manufacturing, IT, Validation, and Supply Chain to ensure compliance with 21 CFR Part 11, Annex 11 and GxP expectations while enabling digital innovation.

Qualifikationen

• BS/BA in scientific discipline or related field with 5+ years or MS 4+ years of relevant experience in pharmaceutical or related industry.
• Experience in GMP-regulated environments and regulatory expectations.
• Proven ability to lead QA activities for technology transfer and digitalization initiatives.

Aufgaben

• Lead and support QA activities for technology transfer projects, ensuring knowledge transfer and risk management.
• Provide QA leadership for new manufacturing technologies, equipment, and computerized systems.
• Collaborate with Manufacturing, IT, Validation, and Supply Chain to support cross-functional initiatives across IOPS.
• Facilitate governance, risk assessments, and quality decisions for digitalization programs.
• Drive data-driven quality improvements and digital solutions across processes and systems.
• Support MES, electronic batch records, automation platforms, and data integration efforts.

Kenntnisse

Quality assurance

GMP

Technology transfer

Cross-functional collaboration

Risk management

Data-driven decision making

Ausbildung

BS/BA in scientific discipline or related field with 5+ years

MS in scientific field with 4+ years

Tools

MES

Electronic batch records

Automation platforms

Data historians

System integrations

Jobbeschreibung

Regeneron Pharmaceuticals, Inc. in Raheen, Limerick is seeking a Senior QA Specialist to join the Quality Assurance team and drive quality across technology transfer projects.

You will lead QA activities for new manufacturing technologies, equipment, and digital systems, partnering with Manufacturing, IT, Validation, and Supply Chain to ensure compliance with 21 CFR Part 11, Annex 11 and GxP expectations while enabling digital innovation.