Director of Quality Systems

7 days ago

Cork, Cork, Ireland beBeeCompliance Full time €111,900 - €133,350
Quality Assurance Director Role

We are seeking an experienced and skilled Quality Assurance Director to join our team at a leading pharmaceutical company.

Job Description
  • Develop and maintain quality assurance procedures, policies, and systems related to data management and computer system validation (CSV).
  • Ensure all GxP computerized systems meet CSV requirements and are aligned with global standards.
  • Provide quality direction and governance for QA-owned e-systems and ensure alignment with corporate and regulatory standards.
Key Responsibilities:
  • Quality Systems and Data Integrity: Implement Global CS and DI Quality Standards, provide quality direction and governance for QA-owned e-systems, develop and maintain quality assurance procedures, policies, and systems related to data management and CSV.
  • Computer System Validation (CSV): Ensure all GxP computerized systems meet CSV requirements and are aligned with global standards, oversee validation lifecycle from planning through retirement, provide QA review and approval for CSV deliverables, deviations, and risk-based validation strategies.
  • Regulatory Compliance & Inspection Readiness: Act as a site data lead, serve as Quality SME for data integrity and systems during internal and external inspections, maintain inspection readiness across all supported systems, ensure alignment with corporate and regulatory standards.
  • Continuous Improvement & Strategy: Identify areas for optimization in data flow, system integration, and validation strategies, champion initiatives in digital transformation, data contextualization, and visualization to enhance decision-making and compliance.

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