Principal Quality Assurance Analyst

Job Summary

A company is looking for a Principal Quality Assurance Systems Analyst to join their IT & Corporate Administration team.

Key Responsibilities

• Lead and mentor the validation team, ensuring best practices in system compliance
• Drive validation strategies and documentation for GxP and non-regulated systems
• Collaborate with cross-functional teams to ensure regulatory compliance and quality standards

Required Qualifications

• Bachelor's degree with 12+ years in system quality, compliance, and validation within clinical or pharmaceutical environments
• Proven leadership experience mentoring validation analysts and managing complex projects
• Advanced knowledge of GxP, FDA 21 CFR Part 11, and industry standards (e.g., GAMP 5, ISO 9000)
• Expertise in system testing, requirements documentation, and risk management methodologies
• Strong vendor management experience with SaaS, IaaS, and cloud-based systems