Associate Director Site Data Integrity Lead
- Limerick
- Permanent
- Full-time
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
- 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