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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Associate Director Site Data Integrity Lead


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

Associate Director Site Data Integrity Lead
Our client, a global biopharmaceutical manufacturer are currently recruiting an experienced Associate Director Site Data Integrity Lead to join their team on a permanent basis.

Responsibilities:

  • Oversee quality governance for electronic and computerized systems (e.g., MES, DeltaV, LIMS, ELN, SAP)
  • Lead implementation of data integrity and computer system validation (CSV) processes
  • Manage validation lifecycle, change control, deviations, and CAPAs
  • Support regulatory inspections and maintain inspection readiness
  • Drive continuous improvement and contribute to global quality strategies
  • Train and mentor staff in data integrity and CSV best practices
Requirements:
  • Bachelor’s or higher in Science, Engineering, Computer Science, or related field
  • 10+ years of experience in quality/compliance within biopharma or biotech environments
  • Strong understanding of GMP, CSV (GAMP 5), and global data integrity regulations (e.g., 21 CFR Part 11, Annex 11)
  • Proficiency with lab and manufacturing systems, and validation tools
  • Excellent leadership, communication, and cross-functional collaboration skills
For more information please contact Sinéad Cullen on +353879500821 or [email protected]