IT Applications Analyst - Quality Systems

Regeneron Ireland; Limerick; Sur place; EUR 37 000 - 88 000; Plein temps

Résumé du poste

Regeneron Ireland is seeking an IT Applications Analyst to join our IOPS IT Quality Systems group in Raheen. You will support configuration, implementation, and ongoing maintenance of IT Quality Systems applications, serving as a business-facing technical partner to resolve issues and support end users.

The role requires coordinating enhancements, troubleshooting at app/server level, and owning documentation and change control in a regulated environment. Onsite, Monday–Friday, 8am–4:30pm.

Qualifications

• BS/BA in IT or related field.
• Associate: 0-2 years; Analyst: 2+ years; Senior Analyst: 5+ years.
• Experience with Quality Systems (EDMS, QMS, validation, training, learning management, electronic signatures).
• Ability to support end users and regulatory inspections.
• Experience with documentation and change control processes.

Responsabilités

• Coordinate across departments to gather and implement enhancement requests for IT Quality Systems applications.
• Identify, troubleshoot, and resolve system issues at the application and server level and communicate findings.
• Own IT Applications documentation and configure reports; manage changes and approvals.
• Process IT Applications change control requests with Validation and Quality teams.
• Provide SME support to functional departments during development, implementation, and inspections.
• Perform daily administrative tasks; participate in security access reviews and audits.
• Train IT Applications team members and coordinate system maintenance across the team.

Connaissances

System analysis

Process mapping

Technical writing

Project management

Stakeholder mgmt

Quality systems knowledge

Formation

BS/BA in Information Technology or related field

Outils

Veeva

ComplianceWire/REGN U

OpsTrakker

Box

ValGenesis

Description du poste

At Regeneron, we use science and innovation to develop life-transforming medicines for people with serious diseases. We are seeking an IT Applications Analyst to join our IOPS IT Quality Systems group, supporting the configuration, implementation, and ongoing maintenance of IT Quality Systems applications. In this role, you will serve as a business-facing technical partner - resolving system issues, supporting end users, and ensuring compliant application delivery across electronic document management, quality management, training, and validation systems - while collaborating with Quality, Validation, and functional department teams.

Location: Raheen, Ireland Work model: Monday - Friday 8am - 4:30pm, onsite

Discover your role

• Coordinate across business departments and stakeholders to gather, prioritize, and implement enhancement requests for IT Quality Systems applications


• Identify, troubleshoot, and resolve system issues at the application and server level, communicating findings clearly to management, business process owners, and end users


• Own IT Applications documentation including User Requirement Specifications, Detail Design Specifications, Configuration Test Plans, and summary reports; configure tabular, trend, and label reports


• Process IT Applications change control requests and partner with Validation and Quality teams to ensure system changes follow a compliant development lifecycle approach


• Provide SME support to functional departments on system development, implementation, and enhancement projects; assist with application support before, during, and after regulatory and partner inspections


• Perform daily administrative tasks including user account administration and functional support activities; participate in or lead IT Applications security access reviews and periodic audit trail assessments


• Train IT Applications team members and coordinate with the broader team to implement and maintain systems efficiently and in alignment with business needs

This role requires

• BS/BA in Information Technology or a related field


• Associate: 0-2 years of relevant experience


• Analyst: 2+ years of relevant experience


• Senior Analyst: 5+ years of relevant experience


• May consider equivalent combination of education and experience; level determined based on qualifications


• Experience with Quality Systems including electronic document management, quality management, validation management, training and learning management, electronic signature, and electronic forms systems preferred


• Experience with IT administration of platforms such as Veeva, ComplianceWire/REGN U, OpsTrakker, Box, or ValGenesis desirable


• Experience with technical writing and process mapping; project management experience helpful

Salary Range (annually) €37,000.00 - €88,400.00

We are committed to building a workplace with an inclusive culture.

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.

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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Companies Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.