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, general, 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, d

📌 Associate Director External Quality (Guadalajara)
🏢 MX10 ASTRAZENECA S.A DE C.V.
📍 Guadalajara