Quality Assurance Manager

Job Summary

A company is looking for a Quality Assurance Manager (Contract).

Key Responsibilities

• Review clinical study documentation and regulatory documents
• Handle external and FDA audits
• Oversee and execute operational aspects of Quality Assurance activities

Required Qualifications

• Minimum Bachelor's degree or equivalent in health sciences preferred
• At least 6 years of experience in clinical, regulatory, or quality fields (pharmaceutical/biotech/CRO)
• Detailed knowledge of FDA regulations and GCP/ICH guidelines
• Ability to function independently with minimal supervision
• Working knowledge of Microsoft Office Suite