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Details
Associate Director Site Data Integrity Lead
Reference: | SCA015027 | Location: |
Limerick |
Qualification: | Degree | Experience: | 7-9 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
QA Engineer, QA Executive, QA Manager, QA Specialist, QA Supervisor, QA Validation Specialist, Validation Engineer, Validation Manager
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
- 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
Limerick Allied Healthcare Pharmaceutical Quality Control Biopharmaceutical Laboratory Scientist Packaging Engineer Academic Engineering Clinical Research Medical Device Cork Connected Health Quality Assurance IT Supply Chain Microbiology Biotechnology Manufacturing Executive Sales and Marketing PhD Sales and Marketing Product Development Engineer Diagnostics Scientist Cork City Life Science Pharma Sales Validation Engineer Chemistry Academic Supply Chain Quality Engineering Scientific Dublin Medical Affairs Project Manager Mayo
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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