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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
Validation Engineer Supply Chain Medical Affairs Clinical Research Chemistry Laboratory Scientist Quality Engineering Scientific Pharma Sales Academic Biotechnology Medical Device Mayo Dublin Cork Academic Quality Control Cork City Biopharmaceutical Packaging Engineer Sales and Marketing Diagnostics Pharmaceutical Product Development Engineer Engineering Life Science Microbiology Supply Chain Limerick Sales and Marketing Project Manager Allied Healthcare IT Scientist Connected Health PhD Quality Assurance Manufacturing Executive
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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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