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AstraZeneca • Durham, North Carolina, United States
Salary: 401(k) plan]; pa
Role & seniority: Quality Engineering Manager (senior leadership) overseeing the Quality Engineering (QE) function within Delivery; line/manage QE testers; drive quality strategy and continuous improvement.
Stack/tools: test planning and execution for functional, integration, regression, and performance testing; IQ/OQ validation; test automation; Jira for test management and reporting; documentation aligned with SOPs/WIs; audit readiness and risk management.
Build, lead, and develop a high-performing QE team delivering quality outcomes across study implementations.
Define and enforce test strategies, drive defect management, validation of clinical studies, and automation initiatives.
Collaborate with Product/Engineering to embed QE in workflows, capture UAT feedback, ensure regulatory compliance, and report quality metrics to leadership.
Bachelor’s degree in CS/Engineering or related; proven people leadership in quality engineering.
Expertise in test planning, execution, and automation; clinical study validation and regulatory compliance.
Strong Jira usage, reporting dashboards, stakeholder management, and cross-functional influence.
Experience with SOP/WI development, audit readiness, and multi-time-zone collaboration.
Advanced degree; experience driving organizational change; familiarity with modern testing tools/automation frameworks.
Prior work in health-tech or l
WHY JOIN US? Transform billions of patients’ lives through technology, data, and innovative ways of working. You’re disruptive, decisive, and transformative. Someone excited to use technology to improve patients’ health. We’re building a new Health-tech business – Evinova, a fully-owned subsidiary of AstraZeneca Group. Evinova delivers market-leading digital health solutions that are science-based, evidence-led, and human experience-driven. Thoughtful risks and quick decisions come together to accelerate innovation across the life sciences sector. Be part of a diverse team that pushes the boundaries of science by digitally empowering a deeper understanding of the patients we’re helping. Launch pioneering digital solutions that improve the patients’ experience and deliver better health outcomes. Together, we have the opportunity to combine deep scientific expertise with digital and artificial intelligence to serve the wider healthcare community and create new standards across the sector. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. About the Opportunity: Are you ready to lead a team that drives innovation and quality in clinical study implementations? As a Quality Engineering Manager, you'll spearhead the Quality Engineering function within our Delivery organization, ensuring high-quality execution across study implementations. You'll manage a team of QE testers, optimize processes, and validate clinical studies. Collaborating closely with Product and Engineering teams, you'll ensure seamless integration, compliance with regulatory standards, and continuous improvement in testing practices. This leadership role is pivotal in shaping the QE team’s vision and fostering a culture of quality and innovation. What You'll Do: Team Leadership & Development: Build and lead a high-performing Quality Engineering team responsible for delivering exceptional testing outcomes across all study implementations. Foster a culture of accountability, collaboration, and continuous learning. Quality Engineering Oversight: Define and implement test strategies for functional, integration, regression, and performance testing. Ensure validation of clinical studies through IQ/OQ protocols and automation. Drive defect management and corrective actions to maintain product integrity. Process Optimization & Compliance: Improve QE processes for efficiency and consistency. Maintain SOPs and Work Instructions aligned with regulatory standards and audit readiness. Promote best practices in documentation and risk management. Customer UAT Feedback Integration: Create a structured approach to capture and leverage insights from UAT activities, ensuring findings inform quality improvements and future delivery practices. Cross-Functional Collaboration: Partner with Product and Engineering teams to embed QE principles into development workflows. Support design discussions, influence technical decisions, and ensure smooth handoffs between development and validation phases. Innovation & Continuous Improvement: Introduce modern testing tools and automation frameworks. Monitor industry trends and lead initiatives to improve quality metrics and optimize processes. Risk Management & Issue Resolution: Identify potential quality risks early in the delivery cycle and implement mitigation strategies. Ensure timely escalation and resolution of critical issues to minimize impact on project timelines and deliverables. Stakeholder Communication: Provide clear and timely updates on QE progress, risks, and outcomes to senior leadership and project stakeholders. Prepare reports and dashboards that highlight quality metrics and trends for informed decision-making. Resource Planning & Forecasting: Collaborate with Delivery leadership to forecast QE resource needs based on pipeline and project complexity. Ensure optimal allocation of team members to meet deadlines without compromising quality. Training & Knowledge Sharing: Develop training programs and knowledge-sharing sessions to upskill QE team members and promote best practices across the organization. Essential Skills/Experience: Bachelor’s degree in Computer Science, Engineering, or related field; advanced degree preferred. Proven experience managing a team of testers and driving quality engineering practices in a delivery or product development environment. Strong understanding of validation processes for clinical studies and regulatory compliance. Expertise in test planning, execution, and automation strategies. Hands-on experience with Jira for test management, issue tracking, and building reports and dashboards to communicate quality metrics. Demonstrated ability to lead organizational change and implement process improvements across teams. Excellent stakeholder management and communication skills, with the ability to influence cross-functional teams. Familiarity with SOP/WI development and audit readiness. Experience preparing for and supporting internal and external audits, ensuring documentation and processes meet compliance standards. Must have flexibility; this role requires working with colleagues and stakeholders across different time zones. SO, WHAT’S NEXT? To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them. Where can I find out more? Learn more about Evinova Our Social Media, Follow AstraZeneca on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram Our US Footprint: Powering Scientific Innovation - YouTube Apply now and help us shape the future of digital health! AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing . #LI-Hybrid Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 10-Feb-2026 Closing Date 05-Mar-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.