Associate Director, Quality Assurance

Summary

Join QuartzBio as an Associate Director of Quality Assurance and lead the QA function, shaping and executing a comprehensive QA strategy for our Precision Medicine AI Agent Platform. You will bring deep technical expertise in regression and performance testing for both standard and AI-enabled features. Responsibilities include designing and implementing test plans, ensuring robust validation of AI/ML models, promoting QA best practices, and collaborating with cross-functional stakeholders. You will manage a team, overseeing performance evaluations, coaching, and career development. The ideal candidate has a Bachelor’s degree and 12+ years of relevant experience, including 5+ years managing teams and 6-8 years in a customer-facing role. Experience with SaaS architecture, cloud platforms, agile methodologies, and AI/ML model validation is essential. This role requires strong communication, analytical, and problem-solving skills, along with a strategic mindset and a focus on stakeholder engagement.

Requirements

• Bachelor’s degree related field and a minimum of 12 years of relevant work experience in computer Science, Engineering, Life Sciences, cloud/infrastructure technologies, information technology (IT) consulting/support, systems administration, network operations, software development/support, technology solutions
• 12+ years of experience in software QA
• Minimum 5 years of experience in managing teams
• 6-8 years of experience working in a customer-facing role and leading projects
• Deep understanding of SaaS architecture, cloud platforms (e.g., AWS), and agile development methodologies
• Proven experience with: Regression and performance testing
• AI/ML model validation
• Test automation frameworks
• CI/CD pipeline integration and optimization
• Familiarity with GxP, FDA 21 CFR Part 11, GDPR, or other relevant compliance frameworks
• Proven executive leadership with a strategic mindset and a strong focus on stakeholder engagement, customer satisfaction, and vendor relationship management
• Exceptional communication skills—both written and verbal—with demonstrated ability to present clear, persuasive, and well-organized information to diverse audiences
• Skilled in developing and delivering compelling business proposals and business cases, both orally and in writing
• Experienced in quality management systems (QMS) and maintaining audit readiness across operations
• Strong analytical and problem-solving abilities, with a solid understanding of metrics to forecast and manage project cost, schedule, effort, and quality
• Adept at leading change by establishing effective structures and processes to ensure smooth and successful implementation
• Follow Company's Principle and code of ethics on a day-to-day basis
• Lead the team in understanding and embodying the company's core values
• Provide clear and compelling vision for the organization and communicate it effectively to their teams and stakeholders
• Think strategically and develop plans and initiatives to achieve the organization's goals, while aligning them with the company's overall strategy
• Ability to attract, develop, and retain top talent across multiple teams or functions, creating a culture of learning and growth, identifying skills gaps and providing development opportunities
• Ability to understand and appreciate the needs and perspectives of their team members, creating a positive and inclusive work environment
• Build strong relationships with team members, stakeholders, and other leaders in the organization, fostering collaboration and teamwork
• Ability to inspire and motivate their team members, encouraging them to perform at their best and achieve their full potential
• Effectively manage the performance of their team members, providing feedback, setting expectations, and holding individuals accountable for their results
• Effectively manage conflicts that arise within their team or with other teams, working to find solutions that meet everyone's needs
• Delegate tasks and responsibilities to their team members, empowering them to take on more challenging work and develop their skills
• Recognize and reward the contributions of their team members, creating a positive and supportive culture that values and celebrates success
• Navigate cultural differences and work effectively with team members from diverse backgrounds, promoting inclusion and diversity within their team
• Collaborate effectively with other leaders in the organization, working together to achieve shared goals and drive business success

Responsibilities

• Define and execute a comprehensive QA strategy aligned with the needs of a SaaS platform in the life sciences domain and the company’s broader business objectives, ensuring compliance with industry regulations and standards
• Lead the design and implementation of test plans across functional, regression, performance, scalability, and AI/ML testing; oversee automated test frameworks and CI/CD integrations
• Ensure robust validation of AI/ML models used in clinical or scientific applications, including bias detection, reproducibility, and performance benchmarking
• Promote QA best practices and foster a culture of quality across engineering, product, and operations teams
• Collaborate with cross-functional stakeholders to embed quality throughout the PDLC and SDLC, and define quality requirements, validation strategies, and testing timelines
• Maintain and apply Quality Systems to ensure compliance with specifications, regulatory standards, and internal policies
• Lead internal audit readiness and support external regulatory inspections (e.g., FDA, ISO)
• Act as a liaison between QA and other functional teams to align operational and quality objectives
• Provide strategic QA input for new projects, product development, and technology transfer
• Manage multiple QA members, including performance evaluations, coaching, training, mentoring, and career development
• Communicate quality goals, metrics, risks, and system performance to executive leadership
• Monitor and report on quality metrics, release readiness, and risk assessments
• Stay current with FDA, EU, and global regulatory standards and ensure organizational compliance
• Oversee validation programs, including planning, execution, and documentation of process and equipment validations
• Manage supplier qualifications and collaborate with procurement to ensure vendor compliance
• Drive continuous improvement initiatives and implement cost-effective quality enhancements
• Evaluate and select QA tools, automation frameworks, and technologies; review and approve test strategies, validation protocols, and quality documentation
• Stay informed on emerging trends in quality assurance, compliance, and testing technologies
• Manage relationships with QA vendors, consultants, and third-party testing providers
• Perform other duties as assigned