Director of IT Validation and Risk Management

Job Summary

A company is looking for a Director of IT Quality, Risk, Validation and Change Management.

Key Responsibilities

• Develops and implements IT validation, risk management, and change management SOPs to ensure regulatory compliance
• Manages IT organizational controls related to computer system implementation and ensures alignment with GXP best practices
• Oversees IT quality assurance across the product lifecycle and manages documentation related to IT validation and change management

Required Qualifications

• Bachelor's degree required
• 10 years of experience in GxP IT validation/assurance, IT quality, IT risk, and change management
• 5 years of leadership experience
• Strong experience with GAMP 5 and regulatory inspections
• Experience in FDA regulated environments with a solid understanding of cGxP standards