Quality Systems Manager

Job Summary

Owning and leading formal risk management activities, the remote Quality Systems Manager will drive risk assessments, maintain the Quality Management System (QMS), and compile Annual Product Quality Review (APQR) reports while ensuring compliance with GxP regulatory standards.

Key Responsibilities

• Lead formal risk management activities, including risk assessments and maintaining risk registers using ICH Q9 and FMEA frameworks
• Support the continuous improvement of the QMS and participate in QMS initiatives, including Veeva Vault QMS module implementation
• Compile APQR reports by supporting cross-functional data collection and ensuring timely completion and approval

Required Qualifications

• Bachelor's degree or equivalent in pharmacy, science, mathematics, or engineering
• Minimum of 8 years of experience in a Biotech or Pharmaceutical FDA regulated industry in QA or a related field
• Strong experience in leading risk management activities in a GxP environment
• Knowledge of Lean Six Sigma methodologies or equivalent preferred
• Proficiency in eQMS, preferably with prior Veeva experience, and strong analytical skills