Associate Director Computer Systems Quality Assurance & Data Integrity

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 or