The Global Procurement, Supplier Quality Compliance Specialist will be responsible for supporting cGMP compliance aspects of Regeneron's procurement operations. The major activities include but are not limited to the following: working with team members and our Approved Supplier List (ASL), deviation investigations, CAPAs, supplier audit closures and evidence follow up, support of regulatory inspections, SOP's and revisions, change controls, and Supplier Corrective Action Reports (SCAR).
This role is based onsite at one of our Global Manufacturing & Operations locations, and is not eligible for remote work
A typical day may include:
- 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 accurately.
- 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 key partners.
- Support the Procurement staff as required for assigned categories and participate in other procurement office duties as assigned.
This role may be for you if you
- Have worked on continuous improvement initiatives within quality or procurement / sourcing programs
- Can develop and build key relationships with stakeholders and suppliers to drive results for Regeneron.
- Are an individual who operates with integrity and focus, who will demonstrate these competencies in a progressive environment to help drive change and improvement.
- Have work experience in a QMS which meets the legislative requirements of human medicines in the EU and USA.
- Ability to leverage standard business applications for communicating, presenting and analyzing (Word, Excel, PowerPoint)
To be considered for this role you must possess a bachelor's degree in a relevant field of study plus 3 years of experience in procurement, supplier quality or sourcing. Manufacturing experience in Pharma/BioPharma / cGMP working environment highly 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.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.
Salary Range (annually)
$66,400.00 - $108,400.00
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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