Lead QC Lab IT Applications & Compliance Specialist

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

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