Associate Director, Quality Management – Translational Medicine Oncology

Join Early Oncologys Translational Medicine (TM) Global Operations team todriveon 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 improvementandchampion a culture of quality excellencethat delivershigh-qualityscience 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 improvementsaligned to AZ Global Standards ICHGCP and relevantGxPwhere applicable.

• Providefirstlinequality and compliance advice to enable risk identification change control deviation management CAPA effectiveness andtimelyissue resolution.

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

• Authormaintain and simplifyqualitySOPs work instructions and records; partner with process owners to measure effectiveness and adoptfitforpurposecontrols.

• Champion an engaging quality mindset: coach teams deliver training andrecognize 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

• Bachelors degree insciences (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.

• Strongworking knowledgeof ICH-GCP international regulations and relevant quality guidelines;experiencedinrisk-basedquality change control and issue/CAPA management.

• Demonstrated ability tooperateindependently in a matrix prioritize effectively and communicate across scientific and operational stakeholders.

Preferred qualifications

• Masters 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 recordleadingcross functionalquality improvement projects and readiness foraudits.

• Fluency with digital quality systems and data (e.g.VeevaQMS deviation/CAPA tools document controlmetricsdashboards).

We offer a competitive Total Reward program including a market driven base salary bonus andlong termincentive. 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 teamrepresentingall 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 areprovidedreasonable accommodation toparticipatein 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 $137344.80 - $206017.20. Our positions offer eligibility for various incentivesan 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.