Senior QA Specialist

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 54,200 - 88,400; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality assurance

GMP

Technology transfer

Cross-functional collaboration

Risk management

Data-driven decision making

Education

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

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Senior QA Specialist to join our Quality Assurance team.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Raheen, Limerick

What you’ll do:

• Leading and supporting Quality Assurance activities associated with technology transfer projects, ensuring effective knowledge transfer, risk management, and implementation of quality requirements.
• Providing Quality Assurance project leadership and oversight for the introduction of new manufacturing technologies, equipment, computerized systems, and digital solutions.
• Partnering with Manufacturing, Engineering, IT, Validation, Supply Chain, and other cross-functional stakeholders to support projects and initiatives across IOPS.
• Facilitating project governance, risk assessments, and quality decision‑making for technology implementation and digitalization programs.
• Driving the adoption of data‑driven and digital approaches that enhance quality processes, visibility, review efficiency, compliance, and operational performance.
• Supporting the implementation of systems and technologies including Manufacturing Execution Systems (MES), electronic batch records, automation solutions, data integration platforms, and advanced manufacturing technologies.
• Finding opportunities for process simplification, automation, and digital innovation while ensuring compliance with applicable regulatory requirements and company procedures.
• Supporting the development of quality strategies, procedures, training materials, and governance frameworks associated with new technologies and digital initiatives.
• Monitoring project progress, quality risks, and key performance indicators associated with technology transfer, digitalization, and business transformation programs.

The environment and physical rhythms of this role:

• Excellent project, time, and priority management skills, with the ability to independently manage multiple complex assignments simultaneously, adapt to changing priorities, and drive tasks through to successful completion with minimal supervision.
• Solid understanding of technology transfer principles and lifecycle management within a GMP‑regulated environment.
• Understanding of computerized system implementation, validation principles, data integrity requirements, and applicable regulations including 21 CFR Part 11, Annex 11, and GxP expectations.
• Familiarity with digital manufacturing systems and technologies, including MES, electronic batch records, automation platforms, data historians, analytics tools, and system integrations.
• Knowledge of quality risk management methodologies and their application to new technology implementation and process changes.
• Ability to work optimally across technical and business functions to deliver complex transformation initiatives.
• Experience supporting continuous improvement, digital transformation, operational excellence, or innovation programs within a regulated industry.

Let’s find out if we’re a fit:

• BS/BA in scientific discipline or related field with 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience.

Salary Range (annually)

€54,200.00 - €88,400.00

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.