Associate Director, Quality Assurance

QuartzBio Overview:

QuartzBio (www.quartzbio.com) is a Precision Medicine Intelligence Company.  Our first-in-class Precision Medicine AI Agent Platform enables autonomous data ingestion and conversational insights across the precision medicine value chain. Powered by a network of domain-specific AI agents, our solutions amplify the efforts of operations, translational, informatics, and IT teams, using AI-driven integration of biomarker, sample, and clinical data to create a unified, scalable data ecosystem. R&D teams can shorten time from data to insights, analytics, and visualizations, accelerating study close and time-to-market. Transform the way precision medicine teams work with 360° intelligence. 

Position Summary:

We are seeking a strategic and technically adept Associate Director of Quality Assurance (QA) to lead our QA function in a dynamic, fast-paced environment. In this role, you will bring deep technical expertise, particularly in regression and performance testing for both standard and AI-enabled features of data platform solutions. You will be responsible for shaping and executing a comprehensive QA strategy that ensures the delivery of scalable, compliant, and high-quality software products.

This position is ideal for a seasoned QA leader with a passion for building robust testing frameworks, driving innovation in quality practices, and supporting the development of cutting-edge solutions in the life sciences and healthcare technology space.

Key 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.

Qualifications:

• 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.

Leadership expectations:

• 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.