• 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.

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.

We offer:

• Full-time position with a permanent contract, flexible working hours, and hybrid work format.

• Relocation package to Yerevan for candidates and their immediate family members, including full support with documentation and bureaucracy (bank accounts, residence permit, school contacts, etc.).

• Competitive salary and comprehensive health insurance.

• Corporate benefits: English language courses, gym plan, and office snacks.

• Convenient office location in Yerevan within a 1-minute walk from the metro.

• Structured onboarding, mentorship, and a supportive professional environment.

• Opportunity to work in a multidisciplinary team of bioinformaticians, biologists, physicians, and software engineers developing cutting-edge precision oncology solutions.