QA Manufacturing Software Validation Lead

Serve as technical lead on System core teams to define quality deliverables and ensure compliance with validation and risk management requirements.

Define validation strategies and lead execution of validation activities in accordance with regulated manufacturing software and system requirements.

Draft validation plans, protocols, test designs, and validation reports aligned with SOPs and system lifecycle documentation.

Collaborate with Engineering core teams to identify, troubleshoot, and resolve manufacturing software issues encountered during validation.

Conduct formal safety and security risk assessments per SOPs and drive updates to test protocols and validation processes based on evolving business and system needs