Massachusetts Licensed Clinical Quality Manager

Job Summary

A company is looking for a Senior Manager Clinical Program Quality.

Key Responsibilities

• Provide expert GCP compliance guidance and training to program teams and leadership
• Develop and manage risk-based audit strategies, conducting complex audits in line with GCP policies
• Lead investigations into quality issues and GCP breaches, ensuring effective corrective actions are taken

Required Qualifications

• Bachelor's degree required; advanced degree preferred
• At least 7 years of experience in pharma, biotech, or related healthcare industries
• Minimum 5 years in GCP Quality Assurance or relevant clinical trial roles
• In-depth knowledge of ICH GCP R2 and global clinical regulations
• Advanced auditing expertise with the ability to translate findings into risk-mitigating action plans