Senior IT Applications Analyst — QC Lab Systems

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

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Senior IT Applications Analyst — QC Lab Systems to drive QC Lab IT initiatives, coordinate change control, and ensure GxP compliance. You will collaborate with QC, IT, automation, and external vendors to enhance systems and support regulatory audits.

Ideal candidate has 5+ years in IT applications within a GxP environment, with strong project management and vendor coordination skills. Hybrid/onsite work and cloud experience are valued at Regeneron.

Qualifications

• BS/BA in Information Technology or related field; 5+ years of relevant experience.
• Experience with GxP computerized systems and 21 CFR Part 11.
• Knowledge of quality systems, audits, and validation.
• Ability to coordinate across QC, IT, automation, and external vendors.

Responsibilities

• Act as Technical SME and lead QC Lab IT application initiatives.
• Own IT Applications change control processes and design specifications.
• Apply 21 CFR Part 11 knowledge and participate in regulatory audits.
• Serve as primary integration point between QC, IT, and vendors; evaluate platforms.
• Partner with Validation and Quality teams to ensure compliant development lifecycle.

Skills

Technical SME for QC Lab IT

Change control

GxP compliance

21 CFR Part 11

Vendor integration

Project management

Education

BS/BA in Information Technology

Tools

AWS

Azure

Job description

Build our future together

At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases. We are seeking a Senior IT Applications Analyst — QC Lab Systems to join our IOPS IT team, supporting the configuration, implementation, and ongoing management of IT QC Lab applications and systems. In this role, you will serve as a technical SME and business‑facing partner — driving system enhancements, ensuring GxP compliance, and acting as the primary integration point between QC, IT, automation, and external vendors — while collaborating with Quality, Validation, and laboratory stakeholders. 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 County
• Work model/flexibility: Monday - Friday 8am - 4:30pm

Discover your role

• Act as Technical SME and lead on QC Lab IT application initiatives, coordinating across business departments to gather, prioritize, and implement system enhancement requests
• Own IT Applications change control processes including converting User Requirement Specifications to Detail Design Specifications, writing configuration test plans, and producing summary reports
• Apply working knowledge of 21 CFR Part 11 across GxP computerized systems; identify and remediate compliance gaps and participate in regulatory audits and inspections
• Act as the primary integration point between QC, IT, automation, and external vendors; evaluate vendor platforms and integration tools for orchestration capabilities and lead technical discussions with system integrators and software suppliers
• Partner with Validation and Quality teams to ensure IT applications are implemented following a compliant development lifecycle approach
• Configure tabular, trend, and label reports; lead system security access reviews and periodic audit trail assessments; provide on‑the‑floor guidance and application‑level troubleshooting for end users
• Prioritize day‑to‑day work assignments for analysts within the IT department to support application troubleshooting activities; train IT Applications team members and maintain up‑to‑date training records for self and direct reports
• Support and maintain systems built on cloud and/or hybrid architectures in alignment with lab instrument connectivity and data flow requirements
• Working knowledge of 21 CFR Part 11 and GxP computerized system compliance; experience participating in regulatory audits and inspections preferred
• Understanding of lab instrument connectivity and data flows
• Experience with cloud and/or hybrid architectures (AWS, Azure, or similar) preferred
• Project management experience; professional qualification preferred

This role requires

• BS/BA in Information Technology or a related field with a minimum of 5 years of relevant experience, or equivalent combination of education and experience

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.

Salary Range (annually) €54,200.00 - €88,400.00