Quality Assurance Leadership Position

4 days ago


Cork, Cork, Ireland beBeeQuality Full time €100,000 - €150,000
Associate Director Job Overview

We are seeking a highly skilled Associate Director to lead our quality assurance team. The ideal candidate will be responsible for ensuring the highest standards of product quality and compliance.

Key Responsibilities:
  • Implement global quality standards at a new site.
  • Provide quality direction and governance for e-systems, IT systems, manufacturing systems, and laboratory systems.
  • Develop and maintain quality assurance procedures, policies, and systems related to data management and CSV.
  • Conduct routine self-inspections and monitoring assessments to ensure compliance with current Good Manufacturing Practices, Data Integrity, and other relevant regulations.
  • Participate in organizations to provide consistency across all computer systems areas.
Requirements:
  • 10+ years of leadership experience in quality, compliance, data governance, and lab systems validation and quality assurance.
  • Strong knowledge of regulatory authorities for data integrity, CSV, Quality Risk Management (QRM), and biopharmaceutical regulatory requirements.
  • Deep understanding of lab systems such as LIMS, CDS, ELN, and instrument software validation.


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