Associate Director Site Data Integrity Lead

2 weeks ago

Limerick, Ireland Scientificjobs Full time

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) processesManage validation lifecycle, change control, deviations, and CAPAsSupport regulatory inspections and maintain inspection readinessDrive continuous improvement and contribute to global quality strategiesTrain and mentor staff in data integrity and CSV best practices Requirements:
Bachelor’s or higher in Science, Engineering, Computer Science, or related field10+ years of experience in quality/compliance within biopharma or biotech environmentsStrong 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 toolsExcellent leadership, communication, and cross-functional collaboration skills

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