Manager QA IT - Based Anywhere in Europe

Every day, we rise to the challenge to make a difference and here’s how the Manager QA IT role will make an impact:

• Computer System Validation (CSV) & IT Oversight - lead and support validation activities for laboratory and manufacturing systems (LIMS, CDS, MES, EBR, QMS, etc.). Ensure systems comply with 21 CFR Part 11, Annex 11, and other applicable data integrity requirements. Review and approve user requirements, validation documentation, and change controls related to computerized systems.
• Quality & Compliance - ensure data integrity across all computerized systems in compliance with ALCOA+ principles. Develop and review protocols, and policies related to electronic systems and IT quality processes.
• Collaboration & Support - act as liaison between QA, IT, laboratory staff, and manufacturing operations. Train users on data integrity, electronic records, and compliance with IT-related systems. S...