IT Quality and Compliance Manager

Job Summary

Seeking a full-time salaried IT Quality and Compliance Manager, this role will manage IT Quality, Compliance, and Validation activities across GxP systems, ensuring systems remain compliant, secure, and audit-ready while collaborating closely with the Director of IT Quality & Compliance.

Key responsibilities:

• Execute Computer Software Assurance (CSA) and Computer System Validation (CSV) activities for GxP systems
• Perform internal IT CSV audits and support GxP vendor audits to ensure regulatory compliance
• Conduct vendor qualification and periodic audits, ensuring adherence to GxP, data integrity, and security requirements

Required qualifications:

• Bachelor's degree in IT, Quality, Life Sciences, or related field with a minimum of 5 years of experience in IT Quality, CSV/CSA, or compliance in a GxP environment
• Hands-on experience with IT system validation, internal and vendor audits, and periodic reviews of GxP systems
• Experience supporting or working with GxP lab and manufacturing systems
• Strong knowledge of GxP, 21 CFR Part 11, and data integrity principles
• Proficiency in authoring SOPs, validation documentation, CAPAs, and investigations