Summary

• Manage and coordinate activities associated with the GxP IT Quality Assurance (QA) program for GPS and R&D computerized systems regulatory compliance across the end-to-end product lifecycle (GPS and R&D) for software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and client requirements.

o Carries out functions of the GxP-ITQA as directed including but not limited to:

Review and approval of key computer system Validation Life Cycle (VLC) deliverables;

Review and approval of test scripts and defects associated with computer system validation;

Oversight of key Software Development Life Cycle (SDLC) process such as incident, problem, change, release, etc.;

Ensure adequate and timely regulatory compliance support.

• Partner with IT Validation to ensure risk as...