Supply Chain Workstream Lead
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.
- 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