Associate Director External Quality

The Associate Director External Quality is accountable for providing quality oversight and expert QA leadership across supplier-related projects from planning through execution, close-out, and handover into routine commercial supply. As a key representative of Global Quality within cross-functional project teams, this role ensures GMP and regulatory compliance across activities related to supplier selection, new supplier establishment, technology transfer, validation, audit support, change control, deviation management, issue resolution, product launch, and ongoing supplier maintenance. The role also drives quality improvement initiatives across AstraZeneca and its external network, providing authoritative quality guidance in a complex, global, and highly regulated environment. The position requires strong collaboration with international suppliers and cross-functional stakeholders across multiple countries and time zones, as well as willingness to **travel up to 25% across the Americas region**. Experience in the **manufacture of biologic drug substance (DS) is mandatory**; experience in the manufacture of synthetic drug substance (DS) and/or drug product (DP) will also be considered. **Typical Accountabilities** * **Provide end-to-end quality oversight** for supplier-related projects, ensuring compliance with **cGMP**, AstraZeneca quality standards, and applicable regulatory requirements throughout planning, execution, and close-out. * **Act as the project quality lead** for activities related to **new supplier selection**, supplier establishment, **strategic sourcing**, and **New Product Introduction** projects. * **Support Quality Assurance activities** for **technology transfer**, process validation, qualification activities, and product launch readiness at external manufacturing sites. * **Ensure quality oversight** of **CMOs**, suppliers, and contractors supporting the manufacture of biologic and synthetic drug substances and drug products. * **Lead or support quality activities** related to **change controls**, **deviation investigations**, issue management, risk assessment, and the implementation of corrective and preventive actions. * **Represent Global Quality** within the **External Supply & Manufacturing (ESM)** organization and within the broader project management framework. * **Provide expert QA guidance** to cross-functional teams and external partners to support robust decision-making and effective risk management. * **Drive continuous improvement initiatives** across AstraZeneca and external suppliers to enhance compliance, quality performance, and operational reliability. * **Support audit and inspection readiness**, including internal audits, supplier audits, and regulatory inspection support activities where relevant. * **Contribute to post-validation and post-launch activities**, including **post-approval changes**, lifecycle management, and transition of products into **commercial supply**. * **Build and maintain effective relationships** with global stakeholders, suppliers, and project teams to ensure alignment, accountability, and successful project delivery. **Education** A degree in a **science** or **technical** discipline such as **Pharmacy**, **Biology**, **Chemistry**, **Engineering**, or equivalent experience is required. **Qualifications, Skills and Experience** **Essential**: * Experience in the **manufacture of biologic drug substance (DS) is mandatory**; experience in the manufacture of synthetic drug substance (DS) and/or drug product (DP) will also be considered. * Experience supporting **technology transfer** and **validation** activities at **contract manufacturing organizations**. * Broad **Quality Assurance** knowledge with relevant practical experience in pharmaceutical **operations** and/or **development** environments. * Strong working knowledge of **cGMPs**, **Quality Systems**, and the pharmaceutical **supply chain** environment. * Demonstrated experience working **cross-functionally** and leading significant **improvement initiatives**. * Strong **problem-solving** and decision-making capabilities in complex, regulated environments. * Excellent **oral and written communication** skills. * Strong **negotiation** and **influencing** skills. * Experience providing quality oversight to external suppliers, contractors, or **CMOs**. * Ability to work effectively across multiple countries, cultures, and time zones. * Willingness to travel up to **25%** within the **Americas** region. **Desirable**: * Experience in **Sterile Drug Product Manufacture**. * **Multi-site** and **multi-functional** experience. * Experience in **Quality Assurance** or in combined **Quality** and **Technical** roles. * Knowledge of or certification in **Lean Six Sigma**. * Experience collaborating with **international suppliers** or cross-functional teams across multiple countries in support of quality, technical, and/or supply chain objectives. * Experience supporting **post-approval changes**, launch activities, and transition into **commercial supply**. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.  AstraZeneca offers an environment where your work is valued and impactful. With an unrivalled forward-looking mindset, you'll be at the forefront of innovation, learning how to add real value throughout the lifecycle of our products—from discovery to commercialisation. As the voice of the patient, every batch you certify is a personal stamp of approval. We are committed to improving reliability and excellence in our processes through constant innovation and trailing new models and technologies. Here, you'll feel empowered to make decisions that prioiritise patient safety and quality.  Ready to take on this exciting challenge? Apply now and be part of our journey to deliver life-changing medicines!  **Date Posted** 18-ago-2026 **Closing Date** 21-ago-2026 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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.