Lead CSQA Director & Data Integrity Specialist
We are seeking an experienced professional to lead quality oversight for GxP computerized systems across manufacturing, labs, IT, and logistics. This position requires a deep understanding of data governance and computer system validation strategies.
* Prioritize quality assurance initiatives to ensure compliance with global standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5)
* Develop and implement CSV and data integrity assessment plans
* Act as quality SME during audits and regulatory inspections
* Mentor 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