Senior Software Quality Manager
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Overview
BostonGene is seeking a Senior Software Quality Manager to lead the Software Quality Assurance program and Computer System Validation strategy for regulated software systems in the healthcare sector. BostonGene is redefining cancer patient care and drug development through the integration of omnimodal data and artificial intelligence. Built and validated through an extensive real-world clinical testing network, BostonGene’s foundation model for tumor and immune biology integrates genomic, transcriptomic, and immune data with clinical outcomes to generate biologically grounded, actionable insights. These insights enable biopharma partners to design and de-risk trials, identify novel targets, and optimize therapeutic response prediction across all stages of development while simultaneously improving patient care through clinically integrated innovation.
What you'll do
- •Coordinate the Software Quality Assurance (SQA) program and Computer System Validation (CSV) strategy for regulated software systems supporting medical devices, laboratory systems, and bioinformatics pipelines;
- •Define and implement software quality and validation frameworks across the Software Development Lifecycle (SDLC), ensuring alignment with applicable regulatory requirements (e.g., ISO 13485, GxP, IEC 62304, 21 CFR Part 11);
- •Ensure integration of risk management practices into software development and lifecycle processes in accordance with ISO 14971;
- •Establish and maintain processes for software verification and validation, including test strategy, test planning, execution oversight, and defect management;
- •Partner cross-functionally with Product, Software Development, QA/RA, and other stakeholders to ensure medical device software, laboratory systems, and bioinformatics pipelines are developed, validated, and maintained in a compliant and audit-ready state;
- •Support audit readiness and regulatory inspections by ensuring completeness, accuracy, and traceability of software quality and validation documentation;
- •Coordinate with cross-functional teams and provide subject matter expertise on software quality assurance and validation practices, including considerations for AI/ML-based systems;
- •Ensure software-related documentation and records are complete, accurate, and maintained in accordance with QMS requirements.