QA/RA Manager

Job Summary

A company is looking for a QA/RA Manager.

Key Responsibilities

• Oversee global regulatory affairs and quality assurance activities for pharmaceutical products
• Manage regulatory documentation, submissions, and compliance with complaint management requirements
• Develop systems to enhance quality assurance and maintain regulatory compliance documentation

Required Qualifications

• High school diploma or GED required; Bachelor's degree in a related field preferred
• 5 to 7 years of experience in Regulatory Affairs or Quality Assurance in life sciences preferred
• Experience in a pharmaceutical or biopharmaceutical environment preferred
• Professional certification in Regulatory Affairs or Six Sigma preferred but not required
• Good understanding of CGMP regulations and international guidelines