Supply Chain Workstream Lead - California City, United States - CPL Recruitment

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 [email protected]