Executive Quality Assurance Manager

6 days ago

Cork, Cork, Ireland beBeeQuality Full time €110,000 - €135,000
Quality Assurance Director Role

We are seeking a highly motivated and detail-oriented individual to join our quality assurance team. As a key member of the team, you will play a critical role in developing, designing, and maintaining the quality and regulatory compliance of our biopharmaceutical products.

Key Responsibilities:
  • Implement global CS and DI quality standards.
  • Provide quality direction and governance for QA-owned 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 cGMP and other relevant regulations.
  • Participate in IT and quality organizations to provide consistency across all computer systems areas.
  • Perform and support data flow mapping for production, analytical, and site-wide processes.
  • Ensure accurate documentation of quality records, validation activities, and system-related compliance data.
  • Oversee system change control, deviation management, CAPA, and system periodic review processes.
Requirements:
  • Bachelor's or advanced degree in Science, Engineering, Computer Science, Quality, or a related discipline.
  • 10+ years of leadership experience in quality, compliance, data governance, and lab systems validation and quality assurance.
  • Strong working knowledge of FDA, EMA, HPRA, MHRA, and other 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.
  • Proficiency with validation frameworks (e.g., GAMP 5), risk management, and audit readiness.
  • Experience with enterprise systems (e.g., TrackWise, Veeva, SAP), digital platforms, and automation environments (e.g., MES, DeltaV, DCS).
  • Exceptional communication, cross-functional leadership, and decision-making abilities.

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