Quality and Regulatory Affairs Director

Job Summary

A company is looking for a Deputy Director of Quality and Regulatory Affairs.

Key Responsibilities

• Provide administrative support including scheduling meetings, preparing reports, and maintaining audit and CAPA schedules
• Prepare for internal and external quality audits by organizing documentation and ensuring compliance with relevant standards and regulations
• Assist in implementing and monitoring quality processes and systems to meet organizational standards and objectives

Required Qualifications

• Experience with ISO 9001:2015 and ISO 27001:2022 standards, preferably as an internal or external auditor or Quality Assistant
• Self-starter with the ability to work with minimal supervision
• Strong organizational skills to manage multiple tasks and projects
• Proficiency in MS Office Suite, SharePoint, Salesforce, LITMOS LIMS, and Zendesk
• Statistical analysis background to support data collection and trend identification