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:
1. Oversee quality governance for electronic and computerized systems (e.g., MES, DeltaV, LIMS, ELN, SAP)
2. Lead implementation of data integrity and computer system validation (CSV) processes
3. Manage validation lifecycle, change control, deviations, and CAPAs
4. Support regulatory inspections and maintain inspection readiness
5. Drive continuous improvement and contribute to global quality strategies
6. Train and mentor staff in data integrity and CSV best practices
Requirements:
7. Bachelor's or higher in Science, Engineering, Computer Science, or related field
8. 10+ years of experience in quality/compliance within biopharma or biotech environments
9. Strong understanding of GMP, CSV (GAMP 5), and global data integrity regulations (e.g., 21 CFR Part 11, Annex 11)
10. Proficiency with lab and manufacturing systems, and validation tools
11. Excellent leadership, communication, and cross-functional collaboration skills