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Supply Chain Workstream Lead

Job Introduction

The Opportunity 

Assist with the company’s Remediation Consent Decree and CMC programme(s) to ensure the improvement initiatives are delivered on time. 

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. 

Role Responsibility

  • 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. 
  • Building best practices, skills, and capability throughout the site organization, with the focus in the Logistics and Supply Chain functions. 
  • 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. 

The Ideal Candidate

  • Experience and Skill in Pharmaceutical industry, degree and/or years of experience.
  • Strong background in Regulatory Agency interaction (inspections, response, Warning Letters, Consent Decrees, etc.) 
  • Technical Experience in Design, development, and continuous improvement of vendor management programs. 
  • Experienced in Quality Management Systems, Quality Assurance and Compliance would be a bonus.
  • Remediation of Regulatory actions imposed by Regulatory Authorities (i.e., Warning Letters, Consent Decrees, etc) is desirable.
  • Desired experiences in project management, change management, quality systems, quality assurance, validation, and manufacturing operations. 
  • Ability in creating trusting and collaborative relationships within the organization and with external business partners.

Key Performance Indicators  

  • 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.

Dechra Pharmaceuticals PLC


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