QA Manufacturing Software Validation Lead

Key Responsibilities:

• 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 teams to identify, troubleshoot, and resolve manufacturing software issues encountered during validation.
• Conduct formal safety and security risk assessments and update test protocols and validation processes based on evolving business and system needs.