Associate Director Computer Systems Quality Assurance & Data Integrity
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
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 sinead.cullen@lifescience.ie
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