Senior Manager - IT Quality

Focus Areas

• Computer System Validation (CSV) with a strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards.
• Strong understanding of periodic reviews and audit trail assessments for computer system validations, ensuring compliance, system integrity, and risk identification.
• Manages supplier relationships for software applications, including vendor selection and qualification, contract management, and ensuring timely and quality software delivery.
• Oversees the Quality Management System (QMS) for computerized systems, ensuring compliance, documentation, and continuous process improvement.

Responsibilities

• Strong project management skills with experience supervising quality professionals working with cross functional and global stakeholders across multiple time zones.
• Develop, Mentor, and oversee staff and day-to-day GxP activities.
• Assess ...