IT Quality Principal Specialist

Job Summary

A company is looking for a Principal Specialist - IT Quality.

Key Responsibilities

• Audit and manage process improvements across the IT infrastructure
• Provide program oversight and quality authority for IT compliance related SOPs and policies
• Review and approve all software administrative SOPs within the global network

Required Qualifications

• BS with 8+ years or MS with 6+ years of experience in a QA or GMP environment
• Advanced knowledge of IT infrastructure best practices in a pharmaceutical setting
• Experience in data integrity, computer system validation, and IT quality in an FDA regulated manufacturing environment
• Expert knowledge of 21CFR, Part 11, and EU Annex 11