Associate Director, Quality Management – Translational Medicine Oncology

AstraZeneca • Gaithersburg, MD

5d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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).

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees