Site Lead Auditor, Associate Director ensuring processes conform to regulations at Dundalk facility. Leading internal audits and maintaining compliance for vaccine product development.
Responsibilities
Develop and implement the Site Internal Audit Program
Launch and manage the Permanent Inspection Readiness Program
Lead and perform internal audits including facility, system, and walkthrough audits
Advocate for continuous improvement in Quality Management Systems
Maintain and communicate Quality-related metrics for Site Internal Audit & Inspection Readiness programs
Represent the Quality Management System during Health Authority Inspections and Global Audits
Communicate audit/inspection results to stakeholders and site leaders
Manage CAPA processes for audits and inspections
Requirements
Bachelor’s degree in Biotechnology, Science, or relevant discipline
10+ years of experience in the Biopharma/Pharma Industry, including internal audit/Health Authority Inspection experience
Strong knowledge of cGMPs, US and European cGMP guidelines, ICH, and international regulatory requirements
Excellent communication, decision-making, people influencing, and project management skills
Strong problem-solving and critical thinking skills with the ability to identify potential compliance issues
Self-starter with a focus on results and a desire for continuous learning and improvement
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