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. 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.

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