Senior Manager of Quality Compliance

Job Summary

A company is looking for a Sr. Manager in Quality Standards and Compliance within Global Patient Safety & Risk Management.

Key Responsibilities

• Oversee and maintain the Pharmacovigilance System Master File (PSMF) and collaborate with GVP Quality Assurance
• Support pharmacovigilance audit activities and regulatory inspections in collaboration with GVP Quality Assurance
• Develop and report pharmacovigilance compliance metrics and manage compliance oversight of external groups

Required Qualifications

• Bachelor's degree in life sciences or related field
• Minimum of 5 years in the pharmaceutical or life sciences industry with a focus on pharmacovigilance operations
• Experience with quality management systems (e.g., Veeva) and CAPA processes
• Knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, ICH guidelines)
• Experience in rare diseases therapeutic area is advantageous