Associate Director Computer Systems Quality Assurance & Data Integrity
Reference: | SCA015027 |
Location: |
Limerick
|
Qualification: | Degree | Experience: | 7-9 Years |
Job Type: | Permanent | Salary: |
Not Disclosed |
Associate Director Computer Systems Quality Assurance & Data Integrity
Our client, a global biopharmaceutical manufacturer are currently recruiting an experienced Associate Director to lead Computer Systems Quality Assurance (CSQA) and Site Data Integrity efforts at a next-generation manufacturing site.
Responsibilities:
- Lead quality oversight for GxP computerized systems across manufacturing, labs, IT, and logistics
- Implement and maintain data governance and computer system validation (CSV) strategies
- Ensure compliance with global standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5)
- Oversee system validation lifecycle, change control, and data integrity assessments.
- Act as quality SME during audits and regulatory inspections
- Support integration of digital systems and automation platforms
- Mentor and train staff on CSV and data integrity principles
Requirements:
- Bachelor’s or advanced degree in Science, Engineering, Computer Science, or related field
- 10+ years of experience in quality, data governance, CSV, and regulatory compliance in a GxP environment
- Strong knowledge of regulatory standards (FDA, EMA, HPRA, etc.)
- Proficiency in systems like LIMS, MES, ELN, SAP, and DeltaV
- Proven leadership, communication, and cross-functional collaboration skills
For more information please contact Sinéad Cullen on +353879500821 or [email protected]