• Resolve requests from suppliers and buyers on supplier quality requirements and approved supplier issues. • Working closely with members of supplier quality, supply chain, program quality and engineering to address issues preventing material procurement. • Create and publish supplier quality performance metrics / data. • Analyzing defect and performance data to identifying trends, key drivers and opportunities for improvement. • Assist in management of supplier master data such as Quality Management System and supplier scope changes. • Engineering review of drawings and related documentation to determine appropriate quality requirements for purchased parts.

• Design, develop, and execute automated and manual tests for high-availability, API-enabled applications. • Validate application functionality, performance, and reliability within complex environments. • Develop and maintain test automation frameworks and scripts. • Collaborate with development teams to identify, troubleshoot, and resolve defects. • Analyze test results and provide actionable insights to improve product quality. • Contribute to the continuous improvement of testing processes and methodologies.

• Own, extend, and improve the test strategy and automation framework for our S3 implementation. • Define and articulate quality designs and test plans with appropriate technical depth, focusing on a shift-left approach. • Drive quality across the full development lifecycle — from design review participation through release validation. • Architect and troubleshoot test coverage for system-level components, with emphasis on file system behavior, storage system correctness, and S3 protocol compliance.

• Provide strategic and operational leadership in the planning and executing of GCP Quality activities to support companywide and clinical development/clinical trial Quality activities. • Successfully lead global and cross-functional quality projects • Maintains current knowledge of ever-changing clinical quality guidance and regulations. • Excellent communication and people skills to ensure cohesive and collaborative teamwork. • Demonstrated ability to implement and collaboratively drive company initiatives and policies. • Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections. Lead Quality hosting clinical site inspection by regulatory agencies highly preferred. • Direct experience to successfully manage and oversee CAPA plans (write, review, approve, close). • Successfully demonstrates ability to both conduct and manage sites, internal GCP and vendor audits as well as direct and guide audit follow-up actions. • Establish Quality and Cross-Functional SOPs, processes and associated documents. • Working closely with clinical pharmacovigilance team on supporting clinical trial safety. • Responsible for presenting & updating CGP quality metrics and reporting to Sr. Management. • Other duties as assigned.