Associate Compliance Specialist - Procurement
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The Associate Compliance Specialist - Procurement will support the planning and execution of compliance initiatives utilizing the sourcing process for raw material manufacturers and distributors. 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 distributors.
Responsibilities
* This role requires 5 days onsite and is not open to remote / hybrid work
* 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).
* 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.
Qualifications
* Working knowledge with quality and compliance electronic tools/ systems.
* Individual experienced operating with integrity, focus, and clarity in an environment of ambiguity to drive change and improvement.
* Continuous improvement mindset in identifying areas of improvement and working with leadership to implement them.
* Ability to build strong relationships with stakeholders and suppliers to drive results for Regeneron.
* Experience supporting cross‑functional teams to drive results in SCARs, ASLs, CAPAs, Change Notifications, and related Quality and Compliance processes.
To be considered for this role you must possess a bachelor's degree in a relevant field of study plus 2 years experience in a cGMP environment in quality, compliance and/or procurement, including experience in Pharma/BioPharma.
Work experience within a biopharmaceutical company preferred. Microsoft Office required including strong PowerPoint and Excel skills.
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.
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 reassignmen, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
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