Global Procurement, Supplier Quality Compliance Specialist
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, SOPs and revisions, change controls, and Supplier Corrective Action Reports (SCAR).
Duties and Responsibilities:
* 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.
Requirements:
* 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, Power Point).
Qualifications:
* Bachelor’s degree in a relevant field of study.
* 3 years of experience in procurement, supplier quality or sourcing.
* Manufacturing experience in Pharma/Bio Pharma/cGMP working environment highly preferred.
Salary Range (annually):
$66,400.00 - $108,400.00