Senior Manager, Quality Compliance

Job Summary

A company is looking for a Senior Manager, Quality Standards and Compliance, Global Patient Safety & Risk Management.

Key Responsibilities

• Oversee and maintain the PSMF, providing content to support requirements
• Collaborate with GVP Quality Assurance on pharmacovigilance risk assessments and audit plans
• Develop and report pharmacovigilance compliance metrics to ensure operational performance

Required Qualifications

• Bachelor's degree in life sciences or related field
• Minimum of 5 years in the pharmaceutical or life sciences industry focused on PV operations, quality, and compliance
• Knowledge of global pharmacovigilance guidance and regulations (e.g., FDA, EMA, ICH)
• Experience in rare diseases therapeutic area at a global level is an advantage
• Ability to represent the functional department on pharmacovigilance quality and compliance deliverables