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AstraZeneca • Santanyí, Balearic Islands, Spain
Role & seniority: Quality Engineer Manager; senior leadership role overseeing the Quality Engineering function within Delivery, managing a team of QE testers.
Stack/tools: Clinical study validation (IQ/OQ), functional/integration/regression/performance testing, test automation; Jira for test management and reporting; SOP/WI development; dashboards and metrics for quality communication; risk management practices.
Build, lead, and develop a high-performing QE team; drive accountability, collaboration, and continuous learning.
Define and implement test strategies (functional, integration, regression, performance) and ensure validation of clinical studies; manage defect resolution and quality metrics.
Optimize QE processes, ensure regulatory compliance/audit readiness, integrate QE into product/engineering workflows, and communicate risk and progress to stakeholders.
Proven leadership of a testing/quality engineering team in delivery or product development.
Deep understanding of validation processes for clinical studies and regulatory compliance.
Expertise in test planning, execution, and automation strategies; hands-on with Jira for management and reporting.
Strong stakeholder management and cross-functional influence; experience with SOP/WI development and audit readiness.
Bachelor’s degree in CS/Engineering (advanced degree preferred).
Team Leadership & Development: Build and lead a high-performing Quality Engineering team responsible for delivering outstanding testing outcomes across all study implementations. Foster a culture of accountability, teamwork, 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. Advocate for efficient methods in documentation and risk management.
Customer UAT Feedback Integration: Create a structured approach to collect and leverage insights from UAT activities, ensuring findings advise quality improvements and future delivery practices.
Cross-Functional Teamwork: 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.
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.