Associate Director, Quality Assurance

QuartzBio Overview:

QuartzBio ) 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.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

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