Senior Quality Assurance Director

3 days ago


Athlone, County Westmeath, Ireland beBeeQuality Full time €80,000 - €100,000

Job Overview:

We are seeking a seasoned Quality Assurance professional to spearhead the development and implementation of quality systems, culture, and operational excellence at our GMP-certified pharmaceutical site.

This senior-level position offers a rare opportunity for an experienced QA leader to make a meaningful impact on all aspects of site QA - from audits and change control, to training and risk management.

  • Develop and enhance the quality management system (QMS) in line with GMP and HPRA expectations.
  • Manage change control, document control, CAPAs, and deviations, ensuring robust root cause analysis and effectiveness checks.
  • Promote data integrity, traceability, and compliance across all quality records.

Lead internal/external audits (HPRA, customer, etc.) and drive site-wide risk assessments (ICH Q9).

Implement risk-reducing improvements and deliver GMP training to ensure staff proficiency.

Mentor junior QA staff and cross-functional teams to foster a culture of continuous quality improvement.

Requirements:

  • Bachelor's degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or similar field.
  • 5+ years' experience in GMP QA, ideally in API or pharmaceutical manufacturing.
  • Strong working knowledge of GMP, HPRA regulations, quality systems, CAPA/deviation handling, and training.


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