IT Compliance Analyst (Quality Assurance)

Within this role you will be responsible for ensuring that the 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 an IT Compliance Analyst, a typical day might include, but is not limited to, the following:

1. Providing Technical Writing assistance with GxP documents, Change Controls, Deviations and CAPAs
2. Providing Technical Writing assistance with the completion of System Periodic Reviews
3. Supporting the execution of System Audit Trail Reviews
4. Tracking and reporting on IT quality metrics
5. Championing Data Integrity for all IT systems
6. Representing IT at various site/cross-site meetings
7. Ensuring IT procedures follow regulatory and corporate requirements
8. Ensuring IT personnel are operating in compliance with regulations and procedures
9. Helping ensure the training provided to IT Training personnel is adequate
10. Representing IT or assisting IT SMEs during internal and external audits
11. Ensuring IT Operational Controls are in place and maintained throughout the system lifecycle e.g. Periodic Reviews, Disaster Recovery testing, Performance Monitoring etc.

1. You have experience with technical writing
2. You possess good verbal and written communication skills
3. You enjoy both collaborating with a team as well as working independently to develop solutions to complex problems