GxP Quality Systems Manager

Job Summary

Seeking a full-time Manager/Senior QA Associate, GxP Quality Systems, to manage compliance across quality systems, support GMP and GxP assurance activities, and ensure alignment with regulatory requirements while working onsite in Carlsbad, CA.

Key responsibilities

• Support QMS processes and workflows to ensure compliance with regulatory requirements and Ionis policies
• Generate and present QMS metrics, identifying compliance risks and opportunities for improvement
• Lead cross-functional initiatives to enhance quality system compliance and operational efficiency

Required qualifications

• Bachelor's degree in a science-related or relevant discipline
• 3+ years of experience in quality assurance and quality management
• Strong understanding of quality systems guidelines and regulatory requirements in the pharmaceutical or biotechnology industry
• Familiarity with AI applications in a GxP quality assurance environment is highly desirable
• Strong customer orientation and effective communication skills