Sr Specialist Global Procurement

Regeneron Pharmaceuticals • Rensselaer, NY

51d • Onsite

About The Position

The Sr Specialist; Global Procurement - Compliance will support the planning and execution of compliance initiatives utilizing the sourcing process for raw material manufacturers and distributers. The role supports and maintains all cGMP compliance aspects of Global Procurement operations under the direction and guidance of Sourcing Management. Ensures organization and timely completion of Approved Supplier List documentation in addition to Process deviations assigned to Sourcing (CAPAs, NOEs, EOEs) and supports closure of QA Audits related to audits of raw material manufacturers and distributers.

This role requires onsite 5 days / week - this is not open to remote or hybrid work arrangements

In this role a typical day may include

Supports and proactively maintains all Sourcing cGMP procedures, documentation and training related to SOP and Work Instructions.
Supports and maintains Approved Supplier List (ASL).
Supports compliance needs and coordinates with other sites to ensure engagement, feedback and buy-in related to Global Procurement document revisions.
Supplier Audit Compliance: Drives successful audit closures by focusing on proactive issue resolutions and communication with suppliers to effect acceptable audit closures for raw materials.
Coordinates 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.
Tracks and reports CAPA to support audit closure.
Executes cGMP compliance documents and supports cGMP activities among the Global Procurement team.
Supports and assists with the management of Supplier Corrective Action Reports (SCARs)
Works closely with Legal, QA and Suppliers to help facilitate the execution and management of various agreements, as required.
Completes Global Procurement change controls to ensure they are done correctly and effectively.
Works with Global Procurement staff to review and drives 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.
Supports the Global Procurement staff as required for assigned categories and participates in other procurement office duties as assigned.

Requirements

• Excellent collaboration skills and the ability to work cross functionally across categories and internal stakeholders.
• Understanding of cGMP systems and processes with a particular emphasis on compliance is strongly preferred.
• Familiarity and experience working in an ERP system is preferred
• Ability to build strong relationships with stakeholders and suppliers to drive results for Regeneron.
• Demonstrated success supporting cross-functional teams to drive results in SCARs, ASLs, CAPAs, Change Notifications, and related Quality and Compliance processes.
• Working & operating with integrity, focus, and clarity in an environment of ambiguity to drive change and improvement.
• Continuous improvement mindset in identifying areas of improvements and working with leadership to implement them.
• BS/BA in a related field and at least 5 years of relevant experience in a cGMP environment, preferably in procurement, or equivalent combination of education and experience.
• Microsoft Office required including strong PowerPoint and Excel skills.

Nice To Haves

• Work experience within a biopharmaceutical company preferred.

Responsibilities

• Supports and proactively maintains all Sourcing cGMP procedures, documentation and training related to SOP and Work Instructions.
• Supports and maintains Approved Supplier List (ASL).
• Supports compliance needs and coordinates with other sites to ensure engagement, feedback and buy-in related to Global Procurement document revisions.
• Supplier Audit Compliance: Drives successful audit closures by focusing on proactive issue resolutions and communication with suppliers to effect acceptable audit closures for raw materials.
• Coordinates 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.
• Tracks and reports CAPA to support audit closure.
• Executes cGMP compliance documents and supports cGMP activities among the Global Procurement team.
• Supports and assists with the management of Supplier Corrective Action Reports (SCARs)
• Works closely with Legal, QA and Suppliers to help facilitate the execution and management of various agreements, as required.
• Completes Global Procurement change controls to ensure they are done correctly and effectively.
• Works with Global Procurement staff to review and drives 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.
• Supports the Global Procurement staff as required for assigned categories and participates in other procurement office duties as assigned.

Benefits

• We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
• For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
• For other countries' specific benefits, please speak to your recruiter.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees