Associate Director Computer Systems Quality Assurance & Data IntegrityAssociate Director Computer Systems Quality Assurance & Data IntegrityOur 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 logisticsImplement and maintain data governance and computer system validation (CSV) strategiesEnsure 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 inspectionsSupport integration of digital systems and automation platformsMentor and train staff on CSV and data integrity principlesAssociate Director Computer Systems Quality Assurance & Data IntegrityOur 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 logisticsImplement and maintain data governance and computer system validation (CSV) strategiesEnsure 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 inspectionsSupport integration of digital systems and automation platformsMentor and train staff on CSV and data integrity principlesRequirements:Bachelor’s or advanced degree in Science, Engineering, Computer Science, or related field10+ years of experience in quality, data governance, CSV, and regulatory compliance in a GxP environmentStrong knowledge of regulatory standards (FDA, EMA, HPRA, etc.)Proficiency in systems like LIMS, MES, ELN, SAP, and DeltaVProven leadership, communication, and cross-functional collaboration skillsFor more information please contact Sinéad Cullen on +353879500821 or sinead.cullen@lifescience.ie
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