Associate Director Site Data Integrity Lead

Associate Director Site Data Integrity Lead

Our client, a global biopharmaceutical manufacturer, is 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

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