Quality Engineering Manager - Evinova

AstraZeneca • Durham, NC

1d • Hybrid

About The Position

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.

Requirements

• 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.

Responsibilities

• 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.

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager