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IT Compliance Analyst (Quality Assurance)

Co. Limerick, Ireland
Start date
2 Jun 2024
Closing date
1 Jul 2024

View more

Regulatory Affairs, Compliance
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Job Details

Within this role you will be responsible for ensuring that the IOPS IT group is operating in compliance with Regulatory requirements and Regeneron internal procedures as well being the key liaison between the IT and Quality Assurance groups.

As a IT Compliance Analyst, a typical day might include, but is not limited to, the following: include, but are not limited to, the following GxP activities:
  • Providing Technical Writing assistance with the creation/updating of GxP Documents
  • Providing Technical Writing assistance with the management of Change Controls, Deviations, CAPAs
  • Providing Technical Writing assistance with the completion of System Periodic Reviews.
  • Supporting the execution of System Audit Trail Reviews
  • Tracking and reports on IOPS IT Quality Metrics
  • Championing Data Integrity for all IT systems
  • Representing IOPS IT at various site/cross-site meetings
  • Ensuring IOPS IT procedures follow regulatory and corporate requirements
  • Ensuring IOPS IT personnel are operating in compliance with regulations and procedures.
  • Helping ensure the training provided to IOPS IT Training personnel is adequate
  • Representing IOPS IT or assists IOPS IT SME’s during in internal and external audits
  • Ensuring IT Operational Controls are in place and maintained throughout the system lifecycle e.g., Periodic Reviews, Disaster Recovery testing, Performance Monitoring etc

To be considered for this opportunity you should have BS/BA in related field and a minimum of 2+ years relevant experience preferred; will substitute relevant industry experience for educational requirement. Excellent people skills & Troubleshooting and analytical mindset.


Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.


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