Senior IT Applications Analyst, QC Lab Systems

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

Job summary

Regeneron is seeking a Senior IT Applications Analyst for QC Lab Systems to lead IT application initiatives, ensuring GxP compliance and serving as the SME between QC, IT, automation, and external vendors. The role focuses on driving system enhancements and coordinating validation activities.

You will partner with Quality and Validation teams to implement compliant development life cycles, manage access reviews, and support cloud/hybrid architectures aligned with lab connectivity and data flow

Qualifications

• BS/BA in Information Technology or related field with 5+ years of relevant experience.
• Experience with 21 CFR Part 11 and GxP systems.
• Strong change control and documentation skills.
• Project management experience.

Responsibilities

• Act as Technical SME for QC Lab IT applications and lead enhancements across departments.
• Own IT Applications change control processes including URS to DDS, test plans, and reports.
• Ensure 21 CFR Part 11 compliance and participate in audits/inspections.
• Coordinate with QC, IT, automation and vendors; evaluate integration tools and lead discussions with vendors.

Skills

GxP knowledge

Regulatory audits

Cloud/hybrid architectures

Vendor management

Cross-functional collaboration

Education

Bachelor's degree in Information Technology or related field

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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

€54,200.00 - €88,400.00