Senior Quality Assurance Manager

Job Summary

A company is looking for a Senior Manager, Quality Assurance.

Key Responsibilities

• Manage and maintain quality system processes including Document Control, Change Control, Deviations, and CAPA
• Author, revise, and implement QA GMP standard operating procedures (SOPs)
• Timely management of batch record review and release for clinical trials and marketed products

Required Qualifications

• Bachelor's degree in a scientific discipline or equivalent experience
• Minimum of 7 years of pharmaceutical industry experience in Quality Assurance or relevant roles
• Knowledge of applicable GMP regulations (e.g., CFRs, EuraLex, and ICH)
• Experience in managing and optimizing Quality Management Systems processes
• Ability to support computer system validation and inspection readiness activities