Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Coordinate and maintain all cGMP compliance aspects of Procurement operations, including overseeing day-to-day operations under the direction and guidance of Procurement Management. Ensure organization and timely completion of Approved Supplier List documentation and provide Procurement support to QA Auditing related to audits of raw material manufacturers and distributors.
Essential Duties and Responsibilities include, but are not limited to, the following:
Education and Experience:
* Coordinate, support and proactively maintain all Procurement cGMP procedures, documentation and training related to SOP and Work Instructions.
* Support and maintain Approved Supplier List (ASL).
* Ensure domestic compliance and coordination with international regulatory related to Procurement document control.
* Supplier Audit Compliance - Drive successful audit closures by strategy development, focus on proactive issue resolutions and communication with suppliers to effect acceptable audit closures for raw materials.
* Coordinate efforts of cross functional IOPS Compliance and technical resources to support Procurement and Quality Auditing needs for acceptable closure of regulatory inspections and supplier audit findings.
* Plan and execute cGMP compliance Procurement cGMP needs and coordinate supporting activities among the Procurement team.
* Work closely with Legal, QA and Suppliers to help facilitate the execution and management of various agreements, as required.
* Lead Procurement change controls to ensure they are done correctly and effectively.
* Coordinate Procurement staff to review and drive timely closure of NOE / deviations and associated processes (CAPA).
* Manage 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.
* Designated Procurement representative for interfacing with regulatory inspectors from the FDA and other global regulatory bodies that inspect the Rensselaer site.
Knowledge and Skills:
* Strong attention to detail is required.
* In depth 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 required.
* Excellent collaboration skills and the ability to work cross functionally across categories and internal stakeholders.
* Bachelor's degree required.
* Minimum 3 years of relevant experience in a cGMP environment.
* May consider Associate's degree with at least 5 years of relevant experience in a cGMP environment.
Title level (Compliance Specialist or Senior Compliance Specialist) will be determined based on skills and experience.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.