IT GxP Systems Deviation Management Consultant

Seeking a senior consultant to support enterprise-wide adoption and standardization of deviation management processes across regulated IT and Quality organizations. This role will focus on deviation investigations, process governance, compliance risk assessment, impact analysis, and foundational quality systems education.

Do you have experience in Writing skills?, * Senior consulting experience within regulated Life Sciences environments

• Strong GxP and GMP experience
• Deviation Management experience
• Investigation and Root Cause Analysis experience
• Experience writing inspection-ready deviation reports and documentation
• Experience supporting validated systems and enterprise platforms
• Strong understanding of Clinical, Safety, Quality, or Enterprise regulated systems

Nice to Have Skills:

• Veeva Vault experience
• SAP experience
• Global Patient Safety Systems experience
• Clinical Trial Systems experience
• Quality Management System (QMS) expertise, * Do you have experience working as a consultant within a regulated Life Sciences environment (Pharma, Biotech, Medical Device)?
• Do you have strong GxP and GMP compliance experience?
• Do you have hands-on experience managing deviations in a regulated environment?
• Have you led or participated in deviation investigations and root cause analysis activities?
• Do you have experience writing inspection-ready deviation reports and investigation documentation?
• Do you have experience supporting Clinical, Quality, Safety, or other regulated enterprise systems?
• Have you worked with compliance risk assessments and impact assessments related to deviations?
• Do you have expertise in Quality Management Systems (QMS)?