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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Associate Director Computer Systems Quality Assurance & Data Integrity


Reference:SCA015027 Location: Limerick
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Design Assurance, QA Engineer, QA Executive, QA Manager, QA Specialist, QA Supervisor, QA Validation Specialist, Validation Engineer

Associate Director Computer Systems Quality Assurance & Data Integrity
Our client, a global biopharmaceutical manufacturer are currently recruiting an experienced Associate Director to lead Computer Systems Quality Assurance (CSQA) and Site Data Integrity efforts at a next-generation manufacturing site.

Responsibilities:

  • Lead quality oversight for GxP computerized systems across manufacturing, labs, IT, and logistics
  • Implement and maintain data governance and computer system validation (CSV) strategies
  • Ensure compliance with global standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5)
  • Oversee system validation lifecycle, change control, and data integrity assessments.
  • Act as quality SME during audits and regulatory inspections
  • Support integration of digital systems and automation platforms
  • Mentor and train staff on CSV and data integrity principles
Requirements:
  • Bachelor’s or advanced degree in Science, Engineering, Computer Science, or related field
  • 10+ years of experience in quality, data governance, CSV, and regulatory compliance in a GxP environment
  • Strong knowledge of regulatory standards (FDA, EMA, HPRA, etc.)
  • Proficiency in systems like LIMS, MES, ELN, SAP, and DeltaV
  • Proven leadership, communication, and cross-functional collaboration skills
For more information please contact Sinéad Cullen on +353879500821 or [email protected]