Job Title: Global Procurement, Supplier Quality Compliance Specialist
Description:
The Global Procurement, Supplier Quality Compliance Specialist will support cGMP compliance aspects of Regeneron's procurement operations.
This role is responsible for various activities including working with team members and the Approved Supplier List (ASL), deviation investigations, CAPAs, supplier audit closures and evidence follow-up, support of regulatory inspections, SOPs and revisions, change controls, and Supplier Corrective Action Reports (SCAR).
A typical day may include maintaining all Procurement cGMP procedures, documentation, and training related to SOP and Work Instructions, supporting and maintaining the Approved Supplier List (ASL), and supporting compliance needs by coordinating with other sites to ensure engagement, feedback, and buy-in related to Procurement document revisions.
The Global Procurement, Supplier Quality Compliance Specialist will also drive successful audit closures by focusing on proactive issue resolutions and communication with suppliers to achieve acceptable audit closures for raw materials. Additionally, they will coordinate with Cross-Functional Compliance resources to support Procurement and Quality Auditing needs for acceptable closure of audit findings and secure evidence that substantiates supplier commitments.
The role requires tracking and reporting CAPA to support audit closure, executing cGMP compliance documents, and supporting cGMP activities among the Procurement team. The Global Procurement, Supplier Quality Compliance Specialist will also support and assist with the management of Supplier Corrective Action Reports (SCARs), work closely with Legal, QA, and Suppliers to facilitate the execution and management of various agreements, and complete Procurement change controls to ensure accuracy.
Other responsibilities include reviewing and driving timely closure of NOE/deviations and associated processes (CAPA), acting on Procurement responses to compliance-related requests for data from Regulatory, Quality Assurance, Audit staff, and other key partners, and supporting Procurement staff as required for assigned categories and participating in other procurement office duties as assigned.
Responsibilities:
1. Maintain all Procurement cGMP procedures, documentation, and training related to SOP and Work Instructions.
2. Support and maintain the Approved Supplier List (ASL).
3. Support compliance needs by coordinating with other sites to ensure engagement, feedback, and buy-in related to Procurement document revisions.
4. Drive successful audit closures by focusing on proactive issue resolutions and communication with suppliers to achieve acceptable audit closures for raw materials.
5. Coordinate with Cross-Functional Compliance resources to support Procurement and Quality Auditing needs for acceptable closure of audit findings and secure evidence that substantiates supplier commitments.
6. Track and report CAPA to support audit closure.
7. Execute cGMP compliance documents and support cGMP activities among the Procurement team.
8. Support and assist with the management of Supplier Corrective Action Reports (SCARs).
9. Work closely with Legal, QA, and Suppliers to facilitate the execution and management of various agreements.
10. Complete Procurement change controls to ensure accuracy.
11. Review and drive timely closure of NOE/deviations and associated processes (CAPA).
12. Act on Procurement responses to compliance-related requests for data from Regulatory, Quality Assurance, Audit staff, and other key partners.
13. Support Procurement staff as required for assigned categories and participate in other procurement office duties as assigned.
Requirements:
* Bachelor's degree in a relevant field of study.
* 3 years of experience in procurement, supplier quality or sourcing.
* Manufacturing experience in Pharma/Bio Pharma/cGMP working environment highly preferred.
What We Offer:
We have an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Salary Range:
$66,400.00 - $108,400.00