Associate Director Computer System Quality Assurance & Site Data Lead Associate Director Computer System Quality Assurance & Site Data Lead Get AI-powered advice on this job and more exclusive features.
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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 their 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 Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Quality Assurance and Science Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Life Science Recruitment by 2x
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