Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients.

Summary:
Support and maintain all cGMP compliance aspects of Strategic Sourcing & Procurement (SS&P) operations under the direction and guidance of Sourcing Management. Ensure organization and timely completion of Approved Supplier List documentation in addition to qProcess deviations assigned to Sourcing (CAPAs, NOEs, EOEs) and support closure of QA Audits related to audits of raw material manufacturers and distributers.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Support and proactively maintain all Procurement cGMP procedures, documentation and training related to SOP and Work Instructions.
• Support and maintain Approved Supplier List (ASL).
• Support compliance needs and coordinate with other sites to ensure engagement, feedback and buy in related to Procurement document revisions.
• Supplier Audit Compliance – Drive successful audit closures by focusing on proactive issue resolutions and communication with suppliers to effect acceptable audit closures for raw materials.
• Coordinate with Cross Functional Compliance resources to support Procurement and Quality Auditing needs for acceptable closure of audit findings and to secure evidence that substantiates supplier commitments. Track and report CAPA to support audit closure.
• Execute cGMP compliance documents and support cGMP activities among the Procurement team.
• Support and assist with the management of Supplier Corrective Action Reports (SCARs)
• Work closely with Legal, QA and Suppliers to help facilitate the execution and management of various agreements, as required.
• Complete Procurement change controls to ensure they are done correctly and effectively.
• Work with Procurement staff to review and drive timely closure of NOE / deviations and associated processes (CAPA).
• Action the Procurement responses to compliance related requests for data from Regulatory, Quality Assurance, Audit staff and other stakeholders.
• Support the Procurement staff as required for assigned categories and participate in other procurement office duties as assigned.

Knowledge and Skills:

• Strong attention to detail is required.
• Understanding of cGMP systems and processes with a particular emphasis on compliance is strongly preferred.
• Microsoft Office required including strong Power Point and Excel skills.
• Familiarity and experience working in an ERP system is preferred.
• Excellent collaboration skills and the ability to work cross functionally across categories and internal stakeholders

Education and Experience:

• A 3rd Level Qualification in a related area. Relevant work experience may be substituted for educational experience.
• Experience with Supplier Relationship Management and 0-3 years of progressive experience in Procurement with an emphasis on Raw Materials experience.

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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.