Manager, Verification & Validation

Manager, Verification & Validation

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

We are offering an exciting opportunity to join our organization as a Manager, Verification & Validation (V&V). In this leadership role, you will lead the Verification & Validation strategy for software-enabled life science products, ensuring high-quality, reliable, and compliant product releases. You will manage a team of Verification & Validation engineers responsible for validating laboratory software, AI-enabled applications, and agentic workflows supporting flow cytometry and cell analysis solutions.

The ideal candidate combines strong scientific domain expertise in Flow Cytometry, Cell Analysis, and Sample Preparation with extensive experience in software V&V, wet lab experimentation, AI validation, and people leadership. You will collaborate with Product Management, Software Engineering, Systems Engineering, Quality, Regulatory, and Scientific teams to define validation strategies that ensure product quality, regulatory compliance, and an exceptional customer experience.

Education/Experience:

• Ph.D. in Life Sciences, Biomedical Engineering, Biotechnology, Bioengineering, Computer Science, or a related scientific discipline.
• 12+ years of industry experience in Software Verification & Validation (V&V), Quality Engineering, Software Testing, or Product Development.
• 8+ years of hands-on wet lab experience in Flow Cytometry, Cell Analysis, and Sample Preparation.
• 5+ years of experience leading and managing Verification & Validation or Quality Engineering teams.
• Demonstrated experience validating software products used in laboratory, life science, or regulated environments.
• Experience working within regulated quality systems (FDA, ISO 13485, IEC 62304, GxP, 21 CFR PART 11) is preferred.

Major Job Responsibilities:

• Lead the Verification & Validation (V&V) organization responsible for validating software products supporting life science and laboratory workflows.
• Manage, mentor, coach, and develop a high-performing Verification & Validation team, fostering technical excellence, innovation, collaboration, and continuous learning.
• Establish team objectives, conduct performance reviews, create development plans, and support career growth for team members.
• Define resource plans, prioritize work across multiple programs, and ensure successful execution of validation activities.
• Develop and implement comprehensive V&V strategies, validation plans, test protocols, and release recommendations.
• Define and execute validation strategies for AI-enabled applications and autonomous agentic workflows.
• Lead verification of multi-agent orchestration, prompt execution, prompt libraries, guardrails, AI decision-making, and AI-generated responses.
• Develop risk-based test strategies covering functional, integration, regression, system, end-to-end, usability, performance, robustness, resilience, and failure-mode testing.
• Collaborate with Product Management, Software Engineering, Systems Engineering, Quality, Regulatory, and Scientific teams throughout the product lifecycle.
• Oversee laboratory data generation, capture, analysis, and traceability required for software validation.
• Review and approve validation documentation, defect reports, validation evidence, and software release recommendations.
• Establish V&V metrics, dashboards, and quality KPIs to monitor product quality and team performance.
• Drive continuous improvement initiatives to enhance validation processes, automation, productivity, and release quality.
• Lead defect triage, risk assessments, root cause investigations, and corrective actions.
• Ensure compliance with internal quality systems and applicable regulatory requirements.
• Support customer, internal, and regulatory audits and ensure audit readiness.
• Partner with leadership on strategic planning, hiring, workforce development, budgeting, and capability expansion for the V&V organization.

Knowledge, Skills, and Abilities:

• Strong domain expertise in Flow Cytometry, Cell Analysis, and Sample Preparation.
• Experience leading software Verification & Validation activities for laboratory or life science products.
• Experience generating, capturing, analyzing, and validating laboratory data.
• Hands-on experience validating agentic AI workflows, including multi-agent orchestration, prompt validation, guardrail testing, and evaluation of AI-generated responses for accuracy, reliability, consistency, and safety.
• Experience developing and executing test strategies for autonomous and agentic workflows, including functional, integration, end-to-end, robustness, resilience, negative, and failure-mode validation.
• Experience validating LLM-based applications, prompt libraries, Retrieval-Augmented Generation (RAG) workflows, AI agents, and AI decision-making behavior.
• Strong understanding of AI validation methodologies, prompt evaluation techniques, guardrail verification, hallucination detection, and responsible AI testing practices.
• Proven experience leading, managing, mentoring, and developing Verification & Validation (V&V) teams, including resource planning, performance management, technical leadership, and career development.
• Experience collaborating with cross-functional engineering, scientific, quality, and regulatory teams.
• Strong understanding of quality systems and regulated product development.
• Strong understanding of AI safety, responsible AI principles, and risk-based validation methodologies.
• Excellent analytical, troubleshooting, and problem-solving skills.
• Strong communication, presentation, and stakeholder management skills.
• Ability to influence technical direction across cross-functional teams.
• Demonstrated leadership, coaching, mentoring, and organizational management capabilities.

Experience Level

Mid Level