Job Description
Within this role you will support and maintain all cGMP compliance aspects of Strategic Sourcing & Procurement (SS&P) operations under the direction and guidance of sourcing management. You'll ensure organization and timely completion of Approved Supplier List documentation in addition to process deviations assigned to sourcing (CAPAs, NOEs, EOEs) and support closure of QA Audits related to audits of raw material manufacturers and distributers. This is a 12-month temporary contract position. As a Compliance Specialist, a typical day might include, but is not limited to, the following: Supporting and proactively maintaining all procurement cGMP procedures, documentation and training related to SOP and Work Instructions Maintaining and managing the Approved Supplier List (ASL) Addressing compliance needs and coordinating with other sites to ensure engagement, feedback and buy in related to 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 procurement and quality auditing needs for acceptable closure of audit findings and to secure evidence that substantiates supplier commitments Tracking and reporting CAPA's to support audit closure Executing cGMP compliance documents and supporting cGMP activities among the procurement team Supporting and assisting with the management of Supplier Corrective Action Reports (SCARs) Working closely with legal, QA and suppliers to help facilitate the execution and management of various agreements, as required Completing procurement change controls to ensure they are done correctly and effectively Working with procurement staff to review and drive timely closure of NOE / deviations and associated processes (CAPA) Actioning the procurement responses to compliance related requests for data from Regulatory, Quality Assurance, Audit staff and other stakeholders Supporting the procurement staff as required for assigned categories and participate in other procurement office duties as assigned This role might be for you if: You have a strong attention to detail You possess a good understanding of cGMP systems and processes with a particular emphasis on compliance You demonstrate good Microsoft Office skills including strong Power Point and Excel You bring experience in working with an ERP system You show excellent collaboration skills and the ability to work cross functionally across categories and internal stakeholders To be considered for this opportunity you should have a 3rd Level Qualification in a related area or 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 preferred. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.