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.

Typical Accountabilities

• Provide end-to-end quality oversightfor supplier-related projects ensuring compliance withcGMP AstraZeneca quality standards and applicable regulatory requirements throughout planning execution and close-out.

• Act as the project quality leadfor activities related tonew supplier selection supplier establishmentstrategic sourcing andNew Product Introductionprojects.

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

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

• Lead or support quality activitiesrelated tochange controlsdeviation investigations issue management risk assessment and the implementation of corrective and preventive actions.

• Represent Global Qualitywithin theExternal 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 includingpost-approval changes lifecycle management and transition of products intocommercial 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 asPharmacyBiologyChemistryEngineering or equivalent experience is required.

Qualifications Skills and Experience

Essential:

• Experience in the manufacture ofbiologicand/orsyntheticdrug substancesordrug products.
• Experience inBiologics Drug Substance Manufacture.
• Experience supportingtechnology transferandvalidationactivities atcontract manufacturing organizations.
• BroadQuality Assuranceknowledge with relevant practical experience in pharmaceuticaloperationsand/ordevelopmentenvironments.
• Strong working knowledge ofcGMPsQuality Systems and the pharmaceuticalsupply chainenvironment.
• Demonstrated experience workingcross-functionallyand leading significantimprovement initiatives.
• Strongproblem-solvingand decision-making capabilities in complex regulated environments.
• Excellentoral and written communicationskills.
• Strongnegotiationandinfluencingskills.
• Experience providing quality oversight to external suppliers contractors orCMOs.
• Ability to work effectively across multiple countries cultures and time zones.
• Willingness to travel up to25%within theAmericasregion.

Desirable:

• Experience inSterile Drug Product Manufacture.
• Multi-siteandmulti-functionalexperience.
• Experience inQuality Assuranceor in combinedQualityandTechnicalroles.
• Knowledge of or certification inLean Six Sigma.
• Experience collaborating withinternational suppliersor cross-functional teams across multiple countries in support of quality technical and/or supply chain objectives.
• Experience supportingpost-approval changes launch activities and transition intocommercial supply.

Date Posted

Closing Date

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.