Job Overview
We are seeking a seasoned professional to lead our Computer Systems Quality Assurance (CSQA) and Site Data Integrity efforts at our next-generation manufacturing site.
Key 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.
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 Delta V.
* Proven leadership, communication, and cross-functional collaboration skills.