Director, Quality Management – Translational Medicine Oncology

Join Early Oncology’s Translational Medicine (TM) Global Operations team to drive on quality across our Translational Medicine and Biomarker Science & Technology (BST) organizations, including Labs, Biomarker Operations, and Translational Strategy. As a key quality partner, you will advise on compliance and risk, lead continuous improvement, and champion a culture of quality excellence that delivers high-quality science to patients.

Key Responsibilities:

• Review, assess, and communicate the status of the Quality Management System (QMS) for TM and BST teams, partnering with stakeholders and business process owners to recommend continuous improvements aligned to AZ Global Standards, ICHGCP and relevant GxP where applicable.

• Provide firstline quality and compliance advice to enable risk identification, change control, deviation management, CAPA effectiveness, and timely issue resolution.

• Conduct targeted selfinspections and laboratory spot checks; analyze trends and drive preventive actions.

• Author, maintain, and simplify quality SOPs, work instructions, and records; partner with process owners to measure effectiveness and adopt fitforpurpose controls.

• Champion an engaging quality mindset: coach teams, deliver training, and recognize best practices.

• Partner and collaborate with quality functions and other relevant partners across AZ R&D network to drive streamline and optimize quality processes.

Minimum qualifications

• Bachelor’s degree in sciences (or equivalent practical experience) and 5+ years of relevant work experience

• Significant pharmaceutical/biotech experience in Quality Assurance/Quality Management supporting clinical research, biomarkers, or regulated labs.

• Strong working knowledge of ICH-GCP, international regulations and relevant quality guidelines; experienced in risk-based quality, change control, and issue/CAPA management.

• Demonstrated ability to operate independently in a matrix, prioritize effectively, and communicate across scientific and operational stakeholders.

Preferred qualifications

• Master’s degree or higher in biology, chemistry, biochemistry, or related field. 3+ Years of relevant experience.

• Experience in biomarker development, human biological sample handling, and/or clinical trial sample lifecycle.

• Track record leading cross functional quality improvement projects and readiness for audits.

• Fluency with digital quality systems and data (e.g., Veeva QMS, deviation/CAPA tools, document control, metrics dashboards).

We offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We have a generous paid time off program and a comprehensive benefits package.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The annual base pay for this position ranges from $170,288 - $255,432.20. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

18-Jun-2026

Closing Date

24-Jun-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.