The Compliance Specialist, Sourcing will support and maintain all cGMP compliance aspects of Strategic Sourcing & Procurement (SS&P) operations under the direction and guidance of Sourcing Management. 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, distributors and all other ASL suppliers.
• Support and proactively maintain all Sourcing 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 SS&P 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 SS&P 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 SS&P 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 SS&P change controls to ensure they are done correctly and effectively.
• Work with SS&P staff to review and drive timely closure of NOE / deviations and associated processes (CAPA.)
• Action the SS&P responses to compliance related requests for data from Regulatory, Quality Assurance, Audit staff and other stakeholders.
• Support the SS&P staff as required for assigned categories and participate in other procurement office duties as assigned.
• Requires BS/BA or higher in a related field, with a minimum of 3 years of relevant experience in a cGMP environment, preferably in Procurement/Quality/Compliance.
• Or five+ years of relevant experience may be substituted for the educational requirement.
• Work experience within a biopharmaceutical company preferred.
• 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 is preferred.
• Excellent collaboration skills and the ability to work cross functionally across categories and internal stakeholders.
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