Senior Manager, Product Validation (Remote)

Quest Diagnostics Careers • Marietta, GA

98d

About The Position

This position is responsible for leading the execution of the system release and validation process across all regulated systems. They will be responsible for managing the Computer Systems Validation process as set out by Pharma Service across all systems deemed covered by the FDA 21CFR Part 11 regulations. They will be responsible for ensuring that all covered systems maintain a validated state throughout their life cycle, ensuring the Master Validation Record for each system is created and updated in compliance with Pharma Services – Technology & Systems Policies and SOPs.

Responsibilities

• Lead the execution of the system release and validation process across all regulated systems.
• Manage the Computer Systems Validation process as per Pharma Service guidelines.
• Ensure compliance with FDA 21CFR Part 11 regulations for all covered systems.
• Maintain a validated state for all covered systems throughout their life cycle.
• Create and update the Master Validation Record for each system in compliance with policies and SOPs.

What This Job Offers

• Number of Employees: 5,001-10,000 employees