We are seeking a proactive and technically skilled Quality Manager to lead complex testing initiatives and strengthen quality practices across our SaaS platform in the life sciences domain. This role blends hands on quality engineering expertise with project leadership, cross functional collaboration, and strategic contributions that support scalable, compliant, and high-quality software delivery.
The Quality Manager will drive the design and execution of comprehensive testing strategies, including functional, regression, performance, and AI/ML validation, to ensure our products meet the highest standards for accuracy, reliability, and regulatory compliance. The role also oversees the development and optimization of automated testing frameworks and CI/CD integrations to support efficient and dependable release cycles.
Working closely with engineering, product, and operations teams, this position ensures quality is embedded throughout the product development lifecycle. The manager supports audit readiness, interprets quality metrics, contributes to SOP and policy development, and ensures consistent QA governance across projects.
Main Duties & Responsibilities:
- Lead the design and execution of functional, regression, performance, and AI/ML testing strategies across multiple product lines or modules.
- Develop and maintain scalable automated test frameworks; optimize CI/CD pipeline integrations for efficiency and reliability.
- Collaborate with engineering, product, and operations teams to embed quality throughout the PDLC and SDLC.
- Ensure rigorous validation of AI/ML models, including bias detection, reproducibility, and performance benchmarking.
- Maintain compliance with internal quality systems and external regulatory standards (e.g., FDA, ISO); contribute to policy and SOP development.
- Support internal audit readiness and lead preparation efforts for external inspections.
- Monitor and analyze quality metrics, release readiness, and risk assessments to inform decision-making.
- Drive continuous improvement initiatives and champion QA best practices across teams.
- Lead cross-functional QA initiatives of moderate to high complexity, including planning, execution, and stakeholder alignment.
- Provide technical leadership and mentorship, shaping QA methodologies and coaching junior engineers on advanced testing techniques.
- Drive innovation and continuous learning by evaluating emerging technologies and integrating them into QA strategies.
- Establish and enforce QA standards and governance to ensure consistency, traceability, and auditability across projects.
- Facilitate strategic communication, translating complex technical findings into actionable insights for senior stakeholders.
- Contribute to vendor strategy and compliance oversight, including qualification, performance evaluation, and risk mitigation.
- Play a key role in strategic planning and decision-making, providing quality-focused input that informs platform architecture, release strategy, and operational priorities.
- Other duties as assigned, including cross-functional collaboration and support of organizational quality goals.
Education and Experience
- Bachelor’s degree in a related field and a minimum of 8 years of relevant experience in cloud/infrastructure technologies, IT consulting/support, systems administration, network operations, software development/support, or technology solutions.
- 4–6 years of experience in customer-facing roles and leading projects.
- Strong experience with test automation tools and performance testing.
- Familiarity with regulatory frameworks such as GxP, FDA 21 CFR Part 11, or GDPR.
- Advanced problem-solving and analytical skills, with the ability to identify root causes and recommend scalable solutions.
- Strong written and verbal communication skills, capable of conveying complex technical concepts to diverse audiences.
- Proficient in project management processes and tools, including scheduling, budgeting, and status reporting across multiple workstreams.
- Skilled in writing complex reports and documentation, presenting findings in a clear, concise, and actionable format.
- Demonstrated leadership and project management capabilities, with experience leading cross-functional initiatives.
- Recognized as a technical resource, providing guidance and expertise to team members and influencing QA practices.
- Proven ability to lead and manage complex projects or functional areas, ensuring alignment with strategic objectives.
- Contributes to the development and execution of departmental strategies, bringing a quality-focused perspective to planning discussions.
Knowledge, Skills, and Competencies
- Advanced Quality Engineering Expertise: Deep knowledge of functional, regression, performance, and AI/ML testing methodologies, with the ability to design and oversee testing strategies across multiple product lines.
- Test Automation & CI/CD Proficiency: Strong capability in building and maintaining scalable automated test frameworks and optimizing CI/CD pipeline integrations to support efficient, reliable releases.
- AI/ML Validation & Quality Controls: Competency in validating AI/ML models, including bias detection, reproducibility, traceability, and performance benchmarking, applying appropriate quality standards.
- Regulatory & Compliance Knowledge : Working knowledge of GxP, FDA 21 CFR Part 11, ISO, GDPR, and other applicable quality and data protection frameworks, with the ability to embed compliance throughout the PDLC/SDLC.
- Cross‑Functional Collaboration & Communication: Ability to communicate complex technical concepts clearly and translate test results into actionable insights for engineering, product, operations, and senior stakeholders.
- Technical Leadership & Mentoring :Demonstrated ability to guide and mentor QA engineers, shape QA methodologies, and provide thought leadership that promotes consistency and quality across teams.
- Analytical & Problem‑Solving Strength: Advanced analytical aptitude for identifying root causes, understanding systemic defects or risks, and developing scalable, long‑term solutions.
- Quality Metrics, Audit Readiness & Governance : Skilled at interpreting quality metrics, assessing release readiness, maintaining audit‑ready documentation, and supporting internal and external inspection activities.
- Project & Release Management Competency: Strong capability in managing multiple workstreams and deliverables, ensuring alignment with timelines, scope, and quality objectives across cross‑functional initiatives.
- Continuous Improvement & Innovation Mindset: Commitment to evaluating emerging technologies, challenging existing practices, and implementing improvements that enhance quality, efficiency, and team capability.
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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.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
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