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.
This role may be for you if you have:
- 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.
To be considered for this role you must possess a 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. Work experience within a biopharmaceutical company preferred. Microsoft Office required including strong PowerPoint and Excel skills.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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.S.-based 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.
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What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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