Bachelor’s degree in Computer Science, Software Engineering, Life Sciences, or a related field
Minimum of 5–7 years of experience in software quality assurance, software validation, or a related role within a regulated environment, preferably supporting medical devices, laboratory systems, or bioinformatics pipelines
Deep expertise in applicable regulatory requirements and standards, including IEC 62304, ISO 13485, 21 CFR Part 11, and GxP
Strong understanding of Software Development Lifecycle (SDLC), Computer System Validation (CSV), and risk management principles (e.g., ISO 14971)
Experience defining or implementing software quality or validation frameworks is preferred
Familiarity with validation and quality considerations for laboratory systems and bioinformatics pipelines, including data integrity, traceability, and reproducibility, is preferred
Familiarity with AI/ML-based systems and related validation considerations is preferred
Solid understanding of cybersecurity principles and cybersecurity testing practices is preferred
Strong analytical, problem-solving, and communication skills, with the ability to translate technical and regulatory risks into business-relevant terms
Fluent in English and Russian, both written and spoken
Our offering
Why Join Us?
Join our team at BostonGene, where your work makes a real difference! As a pioneering biotech company with a global footprint, we're passionate about improving lives through groundbreaking oncology personal healthcare. With a team of over 500 dedicated professionals, we foster an empowering environment where your unique skills contribute to a healthier, better world. At BostonGene, you're not just choosing a career; you're stepping into a role that leverages your talents to create a positive change. Discover a workplace that values you as its most precious asset, offering a competitive benefits package designed to enhance your life and those around you