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