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Associate Director, Quality Management – Translational Medicine Oncology

AstraZeneca PLC
22 hours ago
Full-time
On-site
US - Gaithersburg - MD
Operations
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 $137,344.80 - $206,017.20. 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 08-Apr-2026 Closing Date 07-May-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. 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.