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]
