Senior Software Quality Manager (to Yerevan)

About BostonGene

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. For more information, visit www.BostonGene.com.

Position Summary

We are seeking a Senior Software Quality Assurance Manager to coordinate the Software Quality Assurance (SQA) program and Computer System Validation (CSV) strategy for regulated software systems supporting medical devices and laboratory operations. This role is responsible for establishing and maintaining scalable quality and validation frameworks to ensure compliance with applicable regulatory and internal requirements.

The ideal candidate will define and drive software quality processes across the Software Development Lifecycle (SDLC), including validation planning, risk management, and documentation practices. This position partners cross-functionally with Product, Software Development, and QA/RA teams to ensure systems are developed, validated, and maintained in a compliant and audit-ready state within HealthTech, MedTech, and Biotech environments.

Job responsibilities

• 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.

Required qualifications

• 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.

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.

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.