Quality System Regulatory Compliance Specialist

Role Summary

This role supports the site's Quality System and ensures ongoing compliance with GMP and regulatory requirements. Key duties include managing the internal audit (self-inspection) program, assisting with audit and inspection readiness, and supporting the implementation of core Quality Systems such as deviations, CAPAs, change control, training, and KPIs. The position also helps maintain Quality Plan activities, oversees user access to Quality Systems, and contributes to improving training processes.

Key Responsibilities

• Coordinate the self-inspection program, including plans, reports, and follow-up actions.
• Assist in preparing for audits and regulatory inspections through document coordination and area walkdowns.
• Support quality system processes and compliance activities.
• Compile KPI data for monthly reviews and management reporting.
• Maintain Quality System access and provide administra...