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Supply Chain Workstream Lead - California, United States - Cpl
1 week ago
Description
Seeking Supply Chain Workforce Lead to assist with the company's Remediation Consent Decree and CMC programs to ensure the improvement initiatives are delivered on time.
******Please do not apply if you do not have experience with Regulatory Agency interactions specific to Pharmaceuticals (inspections, response, Warning Letters, Consent Decrees, etc.)******
This Role supports Supply Chain/Quality and reports to the Quality and Technical Operations Remediation Lead.
Travel dependent on project requirements and an in site required presence 80% of the time.
Responsibilities
• Assess and review current practices, advising on appropriate strategies to correct compliance gaps through intermediation controls and/or sustainable corrective/preventive actions.
• Working with regulatory affairs to understand, interpret on agreed CMC submission strategies/commitments for approved products.
• Apply pharmaceutical operational and quality knowledge to highlight inter-process, systems and capability relationships and related activities that require improvement.
• Working with Senior Management, conduct compliance risk assessments, trend analysis, provide and communicate recommendations for compliant business activities.
• Prepare and present project update reports to senior management as required.
Requirements
• Strong background in Regulatory Agency interaction specific to Pharmaceuticals (inspections, response, Warning Letters, Consent Decrees, etc.)
• Technical Experience in Design, development, and continuous improvement of vendor management programs.
• Remediation of Regulatory actions imposed by Regulatory Authorities (i.e., Warning Letters, Consent Decrees, etc) is desirable.
• Proven delivery of large to medium scale CMC and Consent Decree projects involving manufacturing, quality, supply chain and regulatory affairs in support of commercial products.
• Previous experiences working with FDA and participating in regulatory agency inspections.
• Extensive experience in quality, logistics and supply chain departments of a commercial pharmaceutical manufacturing company
if you are interested please send your resume/CV to
