Associate Compliance Specialist

RegeneronLimerickFull-time

As an Associate Compliance Specialist in the Procurement team you will support the planning and execution of compliance initiatives using the sourcing process for raw material manufacturers and distributers. You will maintain all cGMP compliance aspects of Global Procurement operations under the direction and mentorship of Sourcing Management. 

*This role requires 5 days onsite and is not open to remote / hybrid work*

In this role a typical day may include, but is not limited to, the following:

  • Supporting and proactively maintaining all Sourcing cGMP procedures, documentation and training related to SOP and Work Instructions

  • Maintaining the Approved Supplier List (ASL)

  • Coordinating compliance needs and collaborates with other sites to ensure engagement, feedback and consensus related to Global Procurement document revisions

  • Driving successful audit closures by focusing on proactive issue resolutions and communication with suppliers to effect acceptable audit closures for raw materials

  • Coordinating with Cross-Functional Compliance resources to support Global Procurement and Quality Auditing needs for acceptable closure of audit findings and to secure evidence that substantiates supplier commitments

  • Assisting with the management of Supplier Corrective Action Reports (SCARs)

  • Completing change controls to ensure they are done accurately and effectively

  • Working with the global team to review and drive timely closure of NOE / deviations and associated processes (CAPA)

  • Actions the Global Procurement responses to compliance related requests for data from Regulatory, Quality Assurance, Audit staff and other stakeholders

This role may be for you if you have:

  • A proven understanding of quality and compliance electronic tools/ systems and experience supporting cross-functional teams to get results in SCARs, ASLs, CAPAs, Change Notifications, and related Quality and Compliance processes

  • Experience operating with integrity, focus, and transparency in an environment of ambiguity to motivate change and improvement

  • A continuous improvement attitude in identifying areas of improvements and working with leadership to implement them

  • The ability to build positive relationships with partners and suppliers

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