Director of Quality Assurance

1 day ago

Cork, Cork, Ireland beBeeRegulatory Full time €145,000 - €175,000

Associate Director Position

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We are seeking a skilled and experienced professional to take on the role of Associate Director within our quality assurance team. This leadership position plays a pivotal part in ensuring the highest standards of product quality and regulatory compliance.

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The successful candidate will be responsible for implementing global quality standards, providing quality direction and governance for QA-owned systems, and conducting routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations.

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Key responsibilities include:

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  • Developing and maintaining quality and regulatory compliance processes;">
  • Providing guidance and support to team members on quality-related matters;">
  • Collaborating with IT and quality organizations to ensure consistency across all computer systems areas;">
  • Performing data flow mapping for production, analytical, and site-wide processes;">
  • Oversight of system change control, deviation management, CAPA, and system periodic review processes;">
  • Ensuring compliance with FDA, EMA, HPRA, MHRA, and other regulatory authorities' requirements;">
  • Fostering a culture of quality and continuous improvement within the team;">
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The ideal candidate will possess a strong working knowledge of quality risk management, biopharmaceutical regulatory requirements, and lab systems such as LIMS, CDS, ELN, and instrument software validation.

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A bachelor's or advanced degree in Science, Engineering, Computer Science, Quality, or a related discipline is required, with 10+ years of experience in leadership roles in quality, compliance, data governance, and lab systems validation and quality assurance.

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