Job Description

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.

Typical Accountabilities

• Provide end-to-end quality oversightfor 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 leadfor activities related to new supplier selection, supplier establishment, strategic sourcing, and New Product Introductionprojects.

• Support Quality Assurance activitiesfor technology transfer, process validation, qualification activities, and product launch readiness at external manufacturing sites.

• Ensure quality oversightof CMOs, suppliers, and contractors supporting the manufacture of biologic and synthetic drug substances and drug products.

• Lead or support quality activitiesrelated to change controls, deviation investigations, issue management, risk assessment, and the implementation of corrective and preventive actions.

• Represent Global Qualitywithin the External Supply & Manufacturing (ESM)organization and within the broader project management framework.

• Provide expert QA guidanceto cross-functional teams and external partners to support robust decision-making and effective risk management.

• Drive continuous improvement initiativesacross 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 relationshipswith global stakeholders, suppliers, and project teams to ensure alignment, accountability, and successful project delivery.

Education
A degree in ascienceortechnicaldiscipline such asPharmacy,Biology,Chemistry,Engineering, or equivalent experience is required.

Qualifications, Skills and Experience

Essential

• Experience in the manufacture of biologicand/or syntheticdrug substancesor drug products
• Experience in Biologics Drug Substance Manufacture
• Experience supporting technology transferand validationactivities at contract manufacturing organizations
• Broad Quality Assuranceknowledge with relevant practical experience in pharmaceutical operationsand/or developmentenvironments.
• Strong working knowledge of cGMPs, Quality Systems, and the pharmaceutical supply chainenvironment.
• Demonstrated experience working cross-functionallyand leading significant improvement initiatives
• Strong problem-solvingand decision-making capabilities in complex, regulated environments.
• Excellent oral and written communicationskills.
• Strong negotiationand influencingskills.
• 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 Americasregion.

Desirable

• Experience in Sterile Drug Product Manufacture
• Multi-siteand multi-functionalexperience.
• Experience in Quality Assuranceor in combined Qualityand Technicalroles.
• Knowledge of or certification in Lean Six Sigma
• Experience collaborating with international suppliersor 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

Date Posted

06-jul-2026

Closing Date

17-jul-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.