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:
1. Lead quality oversight for GxP computerized systems across manufacturing, labs, IT, and logistics
2. Implement and maintain data governance and computer system validation (CSV) strategies
3. Ensure compliance with global standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5)
4. Oversee system validation lifecycle, change control, and data integrity assessments.
5. Act as quality SME during audits and regulatory inspections
6. Support integration of digital systems and automation platforms
7. Mentor and train staff on CSV and data integrity principles
Requirements:
8. Bachelor's or advanced degree in Science, Engineering, Computer Science, or related field
9. 10+ years of experience in quality, data governance, CSV, and regulatory compliance in a GxP environment
10. Strong knowledge of regulatory standards (FDA, EMA, HPRA, etc.)
11. Proficiency in systems like LIMS, MES, ELN, SAP, and DeltaV
12. Proven leadership, communication, and cross-functional collaboration skills
For more information please contact Sinéad Cullen on +353879500821 or sinead.cullen@lifescience.ie